Anxiety DisordersNCT02126787
Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment
A study testing Intensive Group Analytic Psychotherapy and Intensive transdiagnostic cognitive-behavioral group therapy in people with Anxiety Disorders and Depressive Disorders, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders, Personality Disorders
- What is being tested?
- Intensive Group Analytic Psychotherapy and Intensive transdiagnostic cognitive-behavioral group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Axis I anxiety disorder (based on M.I.N.I.)
- Diagnosis of comorbid personality disorder (based on SCID II) or depressive disorder (based on M.I.N.I.)
- Age: 18 to 65 years
- Sufficient knowledge of the Polish language
- Written informed consent of the patient
Who cannot join
- Organic disorder
- Acute substance related disorders
- Schizophrenia, bipolar affective disorder
- Severe depression [over 26 points in Beck Questionnaire] or bipolar disorder.
- Dissocial personality disorder, schizotypal personality disorder
- Current suicidal ideation with a high risk of suicide
Show all 10Show fewer
- Restriction of intellectual capacity
- Serious unstable medical problems/complications
- Concurrent psychotherapeutic treatment
- Failed treatment of CBT or psychodynamic psychotherapy for anxiety
Trial locations and contacts
1 site in 1 country.
Poland1 site
Hospital of Wola
Warsaw, Warsaw, 01-211
Andrzej Kokoszka, MD, PhD
Paweł Holas, MD. PhD
About this study
Official title: Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment of Anxiety Disorders and Comorbid Depressive or Personality Disorders
Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. The aim is to determine the effectiveness of the two kinds of day treatments consisting of intensive, short-term group therapy: psychodynamic and cognitive-behavioral for patients with anxiety disorders and comorbid depressive or personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures.
Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety disorders and comorbid depressive or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals will address comorbidity). Primary outcome measures are include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline, post-treatment and 3 months following the end of the therapy.
Discussion: The randomized controlled trial format is used to compare effectiveness of intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for anxiety disorders and comorbid depressive or personality disorders. The rationale is to investigate how effectively anxiety disorders and comorbid personality disorders can be treated in a day hospital typical for Polish healthcare system in 3 months treatment.
Read the detailed description
Anxiety disorders are among the most prevalent mental disorders, with lifetime prevalence of 30% in US (Kessler et al., 2005) and only 9,9% in Poland (Moskalewicz, Wciórka, Kiejna, Wojtyniak, 2012), the study of the similar methodology, like in the U.S. Many studies suggest their strong comorbidity with personality disorders in some countries. Recent meta-analysis of 125 studies conducted by Friborg, Martinussen, Kaiser, Overgård and Rosenvinge (2013) has shown that a risk of comorbid anxiety disorders and personality disorders varies from 35% to 52%. Alongside anxiety disorders, the most frequently co-occurring are cluster C personality disorders. Epidemiologic studies also show high comorbidity rates for anxiety and depressive disorders, ranging from 40%-80% (Jacobi et al., 2004; Lamers et al., 2011). The data on relationships between comorbid mental disorders and treatment outcome is inconsistent. Reviews by Reich and Green (1991) and Reich and Vasile (1993) including 38 studies have shown that comorbid anxiety disorders and personality disorders are negatively related to treatment outcome. However, Dressen and Arntz (1997) after analyzing 15 studies do not share these conclusions.
Day treatment care is directed precisely to the patients who need treatment of a greater intensity and cannot be treated in outpatient care. Group psychotherapy (often used together with pharmacotherapy) is employed in day care since the 1940s (cf. Cameron 1947; Goldman, 1989). This form of therapy is chosen on economic basis. The treatment usually takes place a few days a week and lasts for several months. Different types of psychotherapy or different treatment methods (e.g. therapeutic community, psychodrama, art therapy, psycho-drawing, movie therapy, social skills training) are often applied together. In Poland, group psychotherapy is widely used in day care. Nowadays 300 such wards exist in Poland. Psychotherapy for anxiety disorders and personality disorders lasting for few months (most often three months) is provided for approximately 8000 patients a year (IPIN, 2009).
The effectiveness of day care is investigated to a very small degree, compared to its frequent usage (cf. Marshall et al 2001). However, difficulties in identifying the basic effective components of the treatment and a large diversity of treatment programs make it difficult to generalize the results.
Among a scarce number of published studies, only four were randomized controlled trials (RCT). Three of these studies compared psychotherapy in day care units to outpatient psychotherapy (Tyler et al., 1987; Dick et al., 1991; Arnevik et al., 2009) and one study used a waiting list control group (Piper, Rosie, Azim, \& Joyce, 1993). Tyler et al. (1987) found no significant differences between day care and outpatient care for anxiety disorders. Dick et al. (1991) found a significant difference in the improvement of personality disorder pathology, in favor of day care. In the first study psychotherapy modality was not mentioned, in the second an eclectic psychotherapy was applied. In another study Arnevik et al. (2009), day care (18 week group psychodynamic and cognitive-behavioral psychotherapy) was compared to individual psychotherapy in patients with personality disorders and no significant differences in improvement were observed between the two groups. Piper et al. (1993) found that day care patients suffering from affective disorders and personality disorders experienced a significant improvement that continued in follow-up after 8 months (18 week group psychodynamic psychotherapy), compared to patients in a waiting list control group. Authors of a Cochrane review of day care versus outpatient care notice that because of a small number of existing studies: "there is only limited evidence to justify the provision of day treatment programs and transitional day hospital care, and no evidence to support the provision of day care centers" (Marshall et al. 2001). Existing data is therefore not sufficient to justify the use of group psychotherapy in day care, and more high quality research is needed. The question of which treatment of the two most widely used, psychodynamic or CBT, is more effective also awaits an answer. These questions are relevant in light of the large expenditures incurred by the national health funds financing the treatment. They are also important for the health care in Poland, where this type of treatment is very common.
Objectives
The main objective of the planned research is to evaluate the clinical effectiveness of intensive, short-term, psychodynamic and cognitive-behavioral group psychotherapy for an anxiety disorders with comorbid depressive or personality disorders in day care conditions.
More specific objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures.
Study design
This study is a randomized controlled trial (RCT) in which participants will be allocated to one of the three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) or a waiting-list control group (WL). Participants allocated to the waiting list condition start their treatment after 12-week waiting period. The total duration of the study will be three years. Figure 1 shows the trial design. The study protocol, information brochure and informed consent were approved by the Medical Ethics Committee of the Warsaw Medical University.
Study center
The protocol and the design is part of the research grant given to the II Department of Psychiatry Medical University of Warsaw. The study will be carried out at the day unit Wola Center of Mental Health at Hospital of Wola in Warsaw that is used as clinical setting of the II Department of Psychiatry Medical University of Warsaw.
Participants (recruitment, inclusion and exclusion criteria, randomization)
Participants with anxiety disorders and comorbid personality disorders will be recruited in outpatient clinic. Subjects who meet all the inclusion criteria will be randomized to two modalities of treatments and the waiting list. Inclusion and exclusion criteria are listed in Table 1. The number of excluded patients and reasons for exclusion will be recorded. The diagnostic criteria are based on the DSM-V system. Independent researchers not involved in the treatment will make diagnosis of personality with with the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II; First, Gibbon, Spitzer, Williams, Benjamin, 1997, 2010) and of clinical disorders with International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Masiak \& Przychoda, 1998). Diagnosis and qualification to treatment modality is carried out during ambulatory sessions. Up to 6 individual sessions will be required for the recruitment procedure including 3 sessions with a certified clinical psychologist, 2 sessions with a psychiatrist, and one for outcome measures. Pharmacological consultation take place before randomization. Waiting time before admission is planned to be between 4 and 8 weeks. Participants will be randomized using random numbers tables. Baseline measurement will occur a day before the beginning of therapy. A recruitment flow chart is presented in Figure 1. Patients are planned to be enrolled in the study over a period of three years. Before participating in the study, each patient will be provided with written information about the study and invited to give written consent for inclusion. Participants who will not meet the inclusion criteria will be offered suitable alternative treatment options. The focus of the treatment is on psychotherapy, but a medication is continued or initiated if necessary during the screening procedure at least 4 weeks before the beginning of a group psychotherapy (stable medical treatments with SSRI or SNRI without dose changes during psychotherapy). Due to high comorbidity of anxiety and depressive disorders, depressive disorders patients with mild depression disorders were not excluded, however patients with main depressive pathology were not included.
Assessments
Patients are subjected to 4 assessments: 1) at screening; 2) baseline after randomization; 3) in the end of the 12 weeks treatment; 4) six months after the end of the therapy, in order to evaluate longer-term effects of the treatments. Information from the screening is used to perform stratified randomization and to validate inclusion and exclusion criteria. Patients are assessed by independent and trained clinicians, who are blind to treatment conditions and who will not be involved in the direct clinical care of any of them. Primary outcome measures and secondary outcome measures can be distinguished in this study. Primary outcome measures include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life. The following socio-demographic data will be collected: sex, age, marital status, education, past treatments, symptom history, medication. We also examine patients' expectancy for change and treatment. Some of the variables (e.g. presence or absence of a personality disorder) will be treated in exploratory analyses as predictors and moderators of treatment response.
- Being tested
- Intensive Group Analytic Psychotherapy, Intensive transdiagnostic cognitive-behavioral group therapy
- Keywords
- Anxiety disorders, Depressive disorders, Personality disorders, Psychodynamic psychotherapy, Cognitive-behavioral psychotherapy, Group psychotherapy, Day treatment
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Group Analytic PsychotherapyBehavioural
The form of intensive group analytic therapy to be used in the trial has been manualized by the research team for the study. It is rooted in group analysis tradition (Bion 1961; Foulkes \& Anthony, 1965). It is based on two recent group analytic psychotherapy manuals, one developed by Lorentzen (2014), the other by Garland (2010). The manual has been adapted to day treatment setting and also draws on polish psychoanalytical group experiences practiced in a public service. Like in other psychodynamic short-term therapies this approach is more structured and focused on issues relevant to symptoms relief. Thereby additional techniques are used: psychodrama, non-verbal techniques, movie therapy, memoir, summary or relaxation.
Intensive transdiagnostic cognitive-behavioral group therapyBehavioural
GCBT was designed for treatment in naturalistic settings of diagnostically mixed anxiety disorder patients with comorbid Personality Disorders (PD's) (Holas, Szaniawska, Suszek, Błażejewski, \& Kokoszka, in prep.). It is based on the transdiagnostic approach to emotional and particularly anxiety disorders that has been developed over the past ten years (Barlow, 2000; Barlow, Allen, \& Choate, 2004; Norton, 2006), additionally it includes interventions for personality disorders based of schema therapy and modes of personality disorders. This approach assumes a high overlap between anxiety disorders and is focused on the common aspects of them. Intensive GCBT developed by our group shares the classical assumptions of cognitive-behavioral therapy (Beck, 1976).
| Study group | Role | What they receive |
|---|---|---|
| Intensive Group Analytic Psychotherapy | Experimental | Intensive Group Analytic Psychotherapy in a day clinic setting Receives: Behavioral: Intensive Group Analytic Psychotherapy |
| Intensive GCBT | Experimental | Intensive transdiagnostic cognitive-behavioral group therapy in a day clinic setting Receives: Behavioral: Intensive transdiagnostic cognitive-behavioral group therapy |
| Wait-list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Measured: week 0 (baseline)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Measured: week 0 (baseline)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: week 0 (baseline)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: week 0 (baseline)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Measured: week 0 (screening)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
Measured: week 0 (screening)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Measured: week 12 (end of treatment)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Measured: week 12 (end of treatment)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: week 12 (end of treatment)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: week 12 (end of treatment)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Measured: week 12 (end of treatment)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
Measured: week 12 (end of treatment)
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Measured: week 24 (follow-up)
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Measured: week 24 (follow-up)
Clinical Global Impression - Severity scale
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Measured: week 24 (follow-up)
Clinical Global Impression - Improvement scale
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: week 24 (follow-up)
Mini-International Neuropsychiatric Interview 5
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Measured: week 24 (follow-up)
Becks Depression Inventory II
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
Measured: week 24 (follow-up)
Secondary outcomes (34)
Structured Clinical Interview for DSM-IV Personality Disorders Questionnaire
Structured Clinical Interview for DSM-IV Personality Disorders Questionnaire (SCID-II; First et al., 1997, Polish version: First et al., 2010). SCID-II is an observer-based diagnostic interview used to determine DSM-IV Axis II disorders.
Measured: week 0 (screening)
Symptoms Checklist
Symptoms Checklist (SCL-90-R; Derogatis, 1994; Polish translation). SCL-90-R consists of 90 items and is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It measures 9 primary symptom dimensions and is designed to provide an overview of a patient's symptoms and their intensity at a specific point in time.
Measured: week 0 (baseline)
Self-Esteem Scale
Self-Esteem Scale (SES; Rosenberg, 1965; Polish version: Dzwonkowska, Lachowicz-Tabaczek \& Łaguna, 2008). The SES is a 10-item self-report scale that measures global self-worth by measuring both positive and negative feelings about the self.
Measured: week 0 (baseline)
Defense Style Questionnaire
Defense Style Questionnaire (DSQ-40; Andrews, Singh \& Bond M, 1993; Polish version: Bogutyn, Kokoszka, Pałczyński \& Holas, 1999). The DSQ-40 is a 40 item self-report questionnaire designed to measure an individual's propensity towards three various defense styles (mature, neurotic and immature) along with twenty individual defense mechanisms.
Measured: week 0 (baseline)
Personality Beliefs Questionnaire
Personality Beliefs Questionnaire (PBQ; Beck \& Beck, 1991; Polish translation). The PBQ is a 126-item self-report measure of beliefs associated with 10 DSM-III-R and DSM-IV personality disorders (represented as subscales): 1) avoidant; 2) dependent; 3) obsessive-compulsive; 4) histrionic; 5) passive-aggressive; 6) narcissistic; 7) paranoid; 8) schizoid; 9) antisocial, and 10) borderline.
Measured: week 0 (baseline)
Inventory of Interpersonal Problems
Inventory of Interpersonal Problems (IIP; Horowitz, Alden, Wiggins, \& Pincus 2000; Polish translation). The IIP is a 64-item self-report questionnaire that inventories the interpersonal problems that people experience. It contains eight scales that assess different aspects of an individual's interpersonal difficulties: 1) domineering/controlling; 2) vindictive/self-centered; 3) cold/distant; 4) socially inhibited; 5) non-assertive; 6) overly accommodating; 7) self-sacrificing; 8) intrusive/needy.
Measured: week 0 (baseline)
Dysfunctional Working Models Scale
Dysfunctional Working Models Scale (DWM-S; Perris, Fowler, Skagerlind, Olsson \& Thorsson, 1998; Polish version: Nieznański, Habrat, Szyszkowski, Chojnowska \& Walczak, 2001). The DWM-S is a 35-item self-report measure of dysfunctional working models of self and others.
Measured: week 0 (baseline)
Experiences in Close Relationships
Experiences in Close Relationships (ECR; Brennan , Clark \& Shaver, 1998; Polish version: Stawska, 2010). The ECR is a 36-item self-report measure of adult attachment. It groups people into four different categories on the basis of scores along two scales: avoidance and anxiety.
Measured: week 0 (baseline)
Bell Object Relations and Reality Testing Inventory
Bell Object Relations and Reality Testing Inventory (BORRTI; Bell, 1995; Polish version: Staniszewski, 2011). The BORRTI is a 45-item self-report measure designed to evaluate the ability to sustain essential relationships and accurately identify internal and external reality.
Measured: week 0 (baseline)
Meta-cognitions Questionnaire
Meta-cognitions Questionnaire (MCQ; Cartwright-Hatton \& Wells, 1997; Polish version: Gawęda \& Kokoszka, 2013). The MCQ is a 65-item self-report scale developed to assess several dimensions of metacognition thought to be relevant to psychopathology. Its five subscales are: 1) positive beliefs about worry; 2) negative beliefs about thoughts concerning uncontrollability and danger; 3) cognitive confidence (assessing confidence in attention and memory); 4) negative beliefs concerning the consequences of not controlling thoughts, and 5) cognitive self-consciousness (the tendency to focus attention on thought processes).
Measured: week 0 (baseline)
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire (FFMQ-S; Baer et al. 2006; Polish translation). FFMQ-S is a 39-item self-report measure which assesses five facets of a general tendency to be mindful in daily life: observing, describing, acting with awareness, nonreactivity to inner experience, and nonjudging of inner experience.
Measured: week 0 (baseline)
Satisfaction With Life Scale
Satisfaction With Life Scale (SWLS; Diener, Emmons, Larsen \& Griffin, 1985; Polish version: Juczyński, 2001). The SWLS is a 5-item self-report global measure of life satisfaction.
Measured: week 0 (baseline)
Credibility/Expectancy Questionnaire
Credibility/Expectancy Questionnaire (CEQ; Devilly \& Borkovec, 2000; Polish translation). CEQ is used to measure expectancy for change and treatment credibility as potential confounds for outcome. It comprises six questions.
Measured: week 0 (baseline)
Symptoms Checklist
Symptoms Checklist (SCL-90-R; Derogatis, 1994; Polish translation). SCL-90-R consists of 90 items and is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It measures 9 primary symptom dimensions and is designed to provide an overview of a patient's symptoms and their intensity at a specific point in time.
Measured: week 12 (end of treatment)
Self-Esteem Scale
Self-Esteem Scale (SES; Rosenberg, 1965; Polish version: Dzwonkowska, Lachowicz-Tabaczek \& Łaguna, 2008). The SES is a 10-item self-report scale that measures global self-worth by measuring both positive and negative feelings about the self.
Measured: week 12 (end of treatment)
Defense Style Questionnaire
Defense Style Questionnaire (DSQ-40; Andrews, Singh \& Bond M, 1993; Polish version: Bogutyn, Kokoszka, Pałczyński \& Holas, 1999). The DSQ-40 is a 40 item self-report questionnaire designed to measure an individual's propensity towards three various defense styles (mature, neurotic and immature) along with twenty individual defense mechanisms.
Measured: week 12 (end of treatment)
Personality Beliefs Questionnaire
Personality Beliefs Questionnaire (PBQ; Beck \& Beck, 1991; Polish translation). The PBQ is a 126-item self-report measure of beliefs associated with 10 DSM-III-R and DSM-IV personality disorders (represented as subscales): 1) avoidant; 2) dependent; 3) obsessive-compulsive; 4) histrionic; 5) passive-aggressive; 6) narcissistic; 7) paranoid; 8) schizoid; 9) antisocial, and 10) borderline.
Measured: week 12 (end of treatment)
Inventory of Interpersonal Problems
Inventory of Interpersonal Problems (IIP; Horowitz, Alden, Wiggins, \& Pincus 2000; Polish translation). The IIP is a 64-item self-report questionnaire that inventories the interpersonal problems that people experience. It contains eight scales that assess different aspects of an individual's interpersonal difficulties: 1) domineering/controlling; 2) vindictive/self-centered; 3) cold/distant; 4) socially inhibited; 5) non-assertive; 6) overly accommodating; 7) self-sacrificing; 8) intrusive/needy.
Measured: week 12 (end of treatment)
Dysfunctional Working Models Scale
Dysfunctional Working Models Scale (DWM-S; Perris, Fowler, Skagerlind, Olsson \& Thorsson, 1998; Polish version: Nieznański, Habrat, Szyszkowski, Chojnowska \& Walczak, 2001). The DWM-S is a 35-item self-report measure of dysfunctional working models of self and others.
Measured: week 12 (end of treatment)
Experiences in Close Relationships
Experiences in Close Relationships (ECR; Brennan , Clark \& Shaver, 1998; Polish version: Stawska, 2010). The ECR is a 36-item self-report measure of adult attachment. It groups people into four different categories on the basis of scores along two scales: avoidance and anxiety.
Measured: week 12 (end of treatment)
Bell Object Relations and Reality Testing Inventory
Bell Object Relations and Reality Testing Inventory (BORRTI; Bell, 1995; Polish version: Staniszewski, 2011). The BORRTI is a 45-item self-report measure designed to evaluate the ability to sustain essential relationships and accurately identify internal and external reality.
Measured: week 12 (end of treatment)
Meta-cognitions Questionnaire
Meta-cognitions Questionnaire (MCQ; Cartwright-Hatton \& Wells, 1997; Polish version: Gawęda \& Kokoszka, 2013). The MCQ is a 65-item self-report scale developed to assess several dimensions of metacognition thought to be relevant to psychopathology. Its five subscales are: 1) positive beliefs about worry; 2) negative beliefs about thoughts concerning uncontrollability and danger; 3) cognitive confidence (assessing confidence in attention and memory); 4) negative beliefs concerning the consequences of not controlling thoughts, and 5) cognitive self-consciousness (the tendency to focus attention on thought processes).
Measured: week 12 (end of treatment)
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire (FFMQ-S; Baer et al. 2006; Polish translation). FFMQ-S is a 39-item self-report measure which assesses five facets of a general tendency to be mindful in daily life: observing, describing, acting with awareness, nonreactivity to inner experience, and nonjudging of inner experience.
Measured: week 12 (end of treatment)
Satisfaction With Life Scale
Satisfaction With Life Scale (SWLS; Diener, Emmons, Larsen \& Griffin, 1985; Polish version: Juczyński, 2001). The SWLS is a 5-item self-report global measure of life satisfaction.
Measured: week 12 (end of treatment)
Self-Esteem Scale
Self-Esteem Scale (SES; Rosenberg, 1965; Polish version: Dzwonkowska, Lachowicz-Tabaczek \& Łaguna, 2008). The SES is a 10-item self-report scale that measures global self-worth by measuring both positive and negative feelings about the self.
Measured: week 24 (follow-up)
Defense Style Questionnaire
Defense Style Questionnaire (DSQ-40; Andrews, Singh \& Bond M, 1993; Polish version: Bogutyn, Kokoszka, Pałczyński \& Holas, 1999). The DSQ-40 is a 40 item self-report questionnaire designed to measure an individual's propensity towards three various defense styles (mature, neurotic and immature) along with twenty individual defense mechanisms.
Measured: week 24 (follow-up)
Personality Beliefs Questionnaire
Personality Beliefs Questionnaire (PBQ; Beck \& Beck, 1991; Polish translation). The PBQ is a 126-item self-report measure of beliefs associated with 10 DSM-III-R and DSM-IV personality disorders (represented as subscales): 1) avoidant; 2) dependent; 3) obsessive-compulsive; 4) histrionic; 5) passive-aggressive; 6) narcissistic; 7) paranoid; 8) schizoid; 9) antisocial, and 10) borderline.
Measured: week 24 (follow-up)
Inventory of Interpersonal Problems
Inventory of Interpersonal Problems (IIP; Horowitz, Alden, Wiggins, \& Pincus 2000; Polish translation). The IIP is a 64-item self-report questionnaire that inventories the interpersonal problems that people experience. It contains eight scales that assess different aspects of an individual's interpersonal difficulties: 1) domineering/controlling; 2) vindictive/self-centered; 3) cold/distant; 4) socially inhibited; 5) non-assertive; 6) overly accommodating; 7) self-sacrificing; 8) intrusive/needy.
Measured: week 24 (follow-up)
Dysfunctional Working Models Scale
Dysfunctional Working Models Scale (DWM-S; Perris, Fowler, Skagerlind, Olsson \& Thorsson, 1998; Polish version: Nieznański, Habrat, Szyszkowski, Chojnowska \& Walczak, 2001). The DWM-S is a 35-item self-report measure of dysfunctional working models of self and others.
Measured: week 24 (follow-up)
Experiences in Close Relationships
Experiences in Close Relationships (ECR; Brennan , Clark \& Shaver, 1998; Polish version: Stawska, 2010). The ECR is a 36-item self-report measure of adult attachment. It groups people into four different categories on the basis of scores along two scales: avoidance and anxiety.
Measured: week 24 (follow-up)
Bell Object Relations and Reality Testing Inventory
Bell Object Relations and Reality Testing Inventory (BORRTI; Bell, 1995; Polish version: Staniszewski, 2011). The BORRTI is a 45-item self-report measure designed to evaluate the ability to sustain essential relationships and accurately identify internal and external reality.
Measured: week 24 (follow-up)
Meta-cognitions Questionnaire
Meta-cognitions Questionnaire (MCQ; Cartwright-Hatton \& Wells, 1997; Polish version: Gawęda \& Kokoszka, 2013). The MCQ is a 65-item self-report scale developed to assess several dimensions of metacognition thought to be relevant to psychopathology. Its five subscales are: 1) positive beliefs about worry; 2) negative beliefs about thoughts concerning uncontrollability and danger; 3) cognitive confidence (assessing confidence in attention and memory); 4) negative beliefs concerning the consequences of not controlling thoughts, and 5) cognitive self-consciousness (the tendency to focus attention on thought processes).
Measured: week 24 (follow-up)
Five Facet Mindfulness Questionnaire
Five Facet Mindfulness Questionnaire (FFMQ-S; Baer et al. 2006; Polish translation). FFMQ-S is a 39-item self-report measure which assesses five facets of a general tendency to be mindful in daily life: observing, describing, acting with awareness, nonreactivity to inner experience, and nonjudging of inner experience.
Measured: week 24 (follow-up)
Satisfaction With Life Scale
Satisfaction With Life Scale (SWLS; Diener, Emmons, Larsen \& Griffin, 1985; Polish version: Juczyński, 2001). The SWLS is a 5-item self-report global measure of life satisfaction.
Measured: week 24 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Wola Hospital, University of Warsaw
- Responsible party
- Principal investigator, Andrzej Kokoszka, Medical University of Warsaw
- Investigators
- Andrzej Kokoszka, MD, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126787
- Sponsor's protocol ID
- NN402464340
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
PubMed 32880104Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Suszek H, Holas P, Wyrzykowski T, Lorentzen S, Kokoszka A. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:319. doi: 10.1186/s13063-015-0827-6.
PubMed 26220089
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term, Intensive Psychodynamic Group Therapy Versus Cognitive-behavioral Group Therapy in the Day Treatment of Anxiety Disorders and Comorbid Depressive or Personality Disorders
- ClinicalTrials.gov ID
- NCT02126787
- Acronym / sponsor ID
- NN402464340
- Keywords
- Anxiety disorders, Depressive disorders, Personality disorders, Psychodynamic psychotherapy, Cognitive-behavioral psychotherapy, Group psychotherapy, Day treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Wola Hospital, University of Warsaw
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. The aim is to determine the effectiveness of the two kinds of day treatments consisting of intensive, short-term group therapy: psychodynamic and cognitive-behavioral for patients with anxiety disorders and comorbid depressive or personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures.
Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety disorders and comorbid depressive or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals will address comorbidity). Primary outcome measures are include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline, post-treatment and 3 months following the end of the therapy.
Discussion: The randomized controlled trial format is used to compare effectiveness of intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for anxiety disorders and comorbid depressive or personality disorders. The rationale is to investigate how effectively anxiety disorders and comorbid personality disorders can be treated in a day hospital typical for Polish healthcare system in 3 months treatment.
Detailed description
Anxiety disorders are among the most prevalent mental disorders, with lifetime prevalence of 30% in US (Kessler et al., 2005) and only 9,9% in Poland (Moskalewicz, Wciórka, Kiejna, Wojtyniak, 2012), the study of the similar methodology, like in the U.S. Many studies suggest their strong comorbidity with personality disorders in some countries. Recent meta-analysis of 125 studies conducted by Friborg, Martinussen, Kaiser, Overgård and Rosenvinge (2013) has shown that a risk of comorbid anxiety disorders and personality disorders varies from 35% to 52%. Alongside anxiety disorders, the most frequently co-occurring are cluster C personality disorders. Epidemiologic studies also show high comorbidity rates for anxiety and depressive disorders, ranging from 40%-80% (Jacobi et al., 2004; Lamers et al., 2011). The data on relationships between comorbid mental disorders and treatment outcome is inconsistent. Reviews by Reich and Green (1991) and Reich and Vasile (1993) including 38 studies have shown that comorbid anxiety disorders and personality disorders are negatively related to treatment outcome. However, Dressen and Arntz (1997) after analyzing 15 studies do not share these conclusions.
Day treatment care is directed precisely to the patients who need treatment of a greater intensity and cannot be treated in outpatient care. Group psychotherapy (often used together with pharmacotherapy) is employed in day care since the 1940s (cf. Cameron 1947; Goldman, 1989). This form of therapy is chosen on economic basis. The treatment usually takes place a few days a week and lasts for several months. Different types of psychotherapy or different treatment methods (e.g. therapeutic community, psychodrama, art therapy, psycho-drawing, movie therapy, social skills training) are often applied together. In Poland, group psychotherapy is widely used in day care. Nowadays 300 such wards exist in Poland. Psychotherapy for anxiety disorders and personality disorders lasting for few months (most often three months) is provided for approximately 8000 patients a year (IPIN, 2009).
The effectiveness of day care is investigated to a very small degree, compared to its frequent usage (cf. Marshall et al 2001). However, difficulties in identifying the basic effective components of the treatment and a large diversity of treatment programs make it difficult to generalize the results.
Among a scarce number of published studies, only four were randomized controlled trials (RCT). Three of these studies compared psychotherapy in day care units to outpatient psychotherapy (Tyler et al., 1987; Dick et al., 1991; Arnevik et al., 2009) and one study used a waiting list control group (Piper, Rosie, Azim, \& Joyce, 1993). Tyler et al. (1987) found no significant differences between day care and outpatient care for anxiety disorders. Dick et al. (1991) found a significant difference in the improvement of personality disorder pathology, in favor of day care. In the first study psychotherapy modality was not mentioned, in the second an eclectic psychotherapy was applied. In another study Arnevik et al. (2009), day care (18 week group psychodynamic and cognitive-behavioral psychotherapy) was compared to individual psychotherapy in patients with personality disorders and no significant differences in improvement were observed between the two groups. Piper et al. (1993) found that day care patients suffering from affective disorders and personality disorders experienced a significant improvement that continued in follow-up after 8 months (18 week group psychodynamic psychotherapy), compared to patients in a waiting list control group. Authors of a Cochrane review of day care versus outpatient care notice that because of a small number of existing studies: "there is only limited evidence to justify the provision of day treatment programs and transitional day hospital care, and no evidence to support the provision of day care centers" (Marshall et al. 2001). Existing data is therefore not sufficient to justify the use of group psychotherapy in day care, and more high quality research is needed. The question of which treatment of the two most widely used, psychodynamic or CBT, is more effective also awaits an answer. These questions are relevant in light of the large expenditures incurred by the national health funds financing the treatment. They are also important for the health care in Poland, where this type of treatment is very common.
Objectives
The main objective of the planned research is to evaluate the clinical effectiveness of intensive, short-term, psychodynamic and cognitive-behavioral group psychotherapy for an anxiety disorders with comorbid depressive or personality disorders in day care conditions.
More specific objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures.
Study design
This study is a randomized controlled trial (RCT) in which participants will be allocated to one of the three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) or a waiting-list control group (WL). Participants allocated to the waiting list condition start their treatment after 12-week waiting period. The total duration of the study will be three years. Figure 1 shows the trial design. The study protocol, information brochure and informed consent were approved by the Medical Ethics Committee of the Warsaw Medical University.
Study center
The protocol and the design is part of the research grant given to the II Department of Psychiatry Medical University of Warsaw. The study will be carried out at the day unit Wola Center of Mental Health at Hospital of Wola in Warsaw that is used as clinical setting of the II Department of Psychiatry Medical University of Warsaw.
Participants (recruitment, inclusion and exclusion criteria, randomization)
Participants with anxiety disorders and comorbid personality disorders will be recruited in outpatient clinic. Subjects who meet all the inclusion criteria will be randomized to two modalities of treatments and the waiting list. Inclusion and exclusion criteria are listed in Table 1. The number of excluded patients and reasons for exclusion will be recorded. The diagnostic criteria are based on the DSM-V system. Independent researchers not involved in the treatment will make diagnosis of personality with with the Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II; First, Gibbon, Spitzer, Williams, Benjamin, 1997, 2010) and of clinical disorders with International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Masiak \& Przychoda, 1998). Diagnosis and qualification to treatment modality is carried out during ambulatory sessions. Up to 6 individual sessions will be required for the recruitment procedure including 3 sessions with a certified clinical psychologist, 2 sessions with a psychiatrist, and one for outcome measures. Pharmacological consultation take place before randomization. Waiting time before admission is planned to be between 4 and 8 weeks. Participants will be randomized using random numbers tables. Baseline measurement will occur a day before the beginning of therapy. A recruitment flow chart is presented in Figure 1. Patients are planned to be enrolled in the study over a period of three years. Before participating in the study, each patient will be provided with written information about the study and invited to give written consent for inclusion. Participants who will not meet the inclusion criteria will be offered suitable alternative treatment options. The focus of the treatment is on psychotherapy, but a medication is continued or initiated if necessary during the screening procedure at least 4 weeks before the beginning of a group psychotherapy (stable medical treatments with SSRI or SNRI without dose changes during psychotherapy). Due to high comorbidity of anxiety and depressive disorders, depressive disorders patients with mild depression disorders were not excluded, however patients with main depressive pathology were not included.
Assessments
Patients are subjected to 4 assessments: 1) at screening; 2) baseline after randomization; 3) in the end of the 12 weeks treatment; 4) six months after the end of the therapy, in order to evaluate longer-term effects of the treatments. Information from the screening is used to perform stratified randomization and to validate inclusion and exclusion criteria. Patients are assessed by independent and trained clinicians, who are blind to treatment conditions and who will not be involved in the direct clinical care of any of them. Primary outcome measures and secondary outcome measures can be distinguished in this study. Primary outcome measures include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life. The following socio-demographic data will be collected: sex, age, marital status, education, past treatments, symptom history, medication. We also examine patients' expectancy for change and treatment. Some of the variables (e.g. presence or absence of a personality disorder) will be treated in exploratory analyses as predictors and moderators of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive Group Analytic Psychotherapy | Experimental | Behavioral: Intensive Group Analytic PsychotherapyIntensive Group Analytic Psychotherapy in a day clinic setting |
| Intensive GCBT | Experimental | Behavioral: Intensive transdiagnostic cognitive-behavioral group therapyIntensive transdiagnostic cognitive-behavioral group therapy in a day clinic setting |
| Wait-list control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current diagnosis of Axis I anxiety disorder (based on M.I.N.I.)
- Diagnosis of comorbid personality disorder (based on SCID II) or depressive disorder (based on M.I.N.I.)
- Age: 18 to 65 years
- Sufficient knowledge of the Polish language
- Written informed consent of the patient
Key exclusion criteria (10 listed)
- Organic disorder
- Acute substance related disorders
- Schizophrenia, bipolar affective disorder
- Severe depression [over 26 points in Beck Questionnaire] or bipolar disorder.
- Dissocial personality disorder, schizotypal personality disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Group Analytic PsychotherapyThe form of intensive group analytic therapy to be used in the trial has been manualized by the research team for the study. It is rooted in group analysis tradition (Bion 1961; Foulkes \& Anthony, 1965). It is based on two recent group analytic psychotherapy manuals, one developed by Lorentzen (2014), the other by Garland (2010). The manual has been adapted to day treatment setting and also draws on polish psychoanalytical group experiences practiced in a public service. Like in other psychodynamic short-term therapies this approach is more structured and focused on issues relevant to symptoms relief. Thereby additional techniques are used: psychodrama, non-verbal techniques, movie therapy, memoir, summary or relaxation. | Behavioural | Intensive Group Analytic Psychotherapy |
| Intensive transdiagnostic cognitive-behavioral group therapyGCBT was designed for treatment in naturalistic settings of diagnostically mixed anxiety disorder patients with comorbid Personality Disorders (PD's) (Holas, Szaniawska, Suszek, Błażejewski, \& Kokoszka, in prep.). It is based on the transdiagnostic approach to emotional and particularly anxiety disorders that has been developed over the past ten years (Barlow, 2000; Barlow, Allen, \& Choate, 2004; Norton, 2006), additionally it includes interventions for personality disorders based of schema therapy and modes of personality disorders. This approach assumes a high overlap between anxiety disorders and is focused on the common aspects of them. Intensive GCBT developed by our group shares the classical assumptions of cognitive-behavioral therapy (Beck, 1976). | Behavioural | Intensive GCBT |
Primary outcome
State-Trait Anxiety Inventory
Time frame: week 0 (baseline)
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Hamilton Anxiety Rating Scale
Time frame: week 0 (baseline)
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Clinical Global Impression - Severity scale
Time frame: week 0 (baseline)
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Clinical Global Impression - Improvement scale
Time frame: week 0 (baseline)
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Mini-International Neuropsychiatric Interview 5
Time frame: week 0 (screening)
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Becks Depression Inventory II
Time frame: week 0 (screening)
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
State-Trait Anxiety Inventory
Time frame: week 12 (end of treatment)
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Hamilton Anxiety Rating Scale
Time frame: week 12 (end of treatment)
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Clinical Global Impression - Severity scale
Time frame: week 12 (end of treatment)
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Clinical Global Impression - Improvement scale
Time frame: week 12 (end of treatment)
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Mini-International Neuropsychiatric Interview 5
Time frame: week 12 (end of treatment)
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Becks Depression Inventory II
Time frame: week 12 (end of treatment)
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
State-Trait Anxiety Inventory
Time frame: week 24 (follow-up)
State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, Jacobs, 1983; Polish version: Wrześniewski, Sosnowski, Matusik, 2002). The STAI measures a person's situational (or state) anxiety, as well as the amount of anxiety a person generally feels most of the time (trait). The two self-report scales contain 20 items each.
Hamilton Anxiety Rating Scale
Time frame: week 24 (follow-up)
Hamilton Anxiety Rating Scale (HAM-A; Hamilton, 1959; Polish translation). The HAM-A is an interviewer-administered and rated measure of the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Clinical Global Impression - Severity scale
Time frame: week 24 (follow-up)
Clinical Global Impression - Severity scale (CGI-S; Guy, 1976; Polish translation). CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Clinical Global Impression - Improvement scale
Time frame: week 24 (follow-up)
Clinical Global Impression - Improvement scale (CGI-I; Guy, 1976; Polish translation). CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Mini-International Neuropsychiatric Interview 5
Time frame: week 24 (follow-up)
Mini-International Neuropsychiatric Interview 5 (M.I.N.I.; Sheehan et al., 1998; Polish version: Masiak \& Przychoda, 1998). M.I.N.I. is a short diagnostic interview based on the DSM-IV criteria that focus on the existence of current psychiatric disorders. It consists of separate modules to diagnose specific disorders.
Becks Depression Inventory II
Time frame: week 24 (follow-up)
Becks Depression Inventory II (BDI-II; Beck, Brown \& Steer, 1996; Polish version: Zawadzki, Popiel \& Pragłowska, 2009) is a 21-item self-report inventory used to assess DSM-IV depressive symptoms. Each item consists of four statements, indicating increasing symptom severity.
34 secondary outcomes
Structured Clinical Interview for DSM-IV Personality Disorders Questionnaire
Time frame: week 0 (screening)
Symptoms Checklist
Time frame: week 0 (baseline)
Self-Esteem Scale
Time frame: week 0 (baseline)
Defense Style Questionnaire
Time frame: week 0 (baseline)
Personality Beliefs Questionnaire
Time frame: week 0 (baseline)
Inventory of Interpersonal Problems
Time frame: week 0 (baseline)
Dysfunctional Working Models Scale
Time frame: week 0 (baseline)
Experiences in Close Relationships
Time frame: week 0 (baseline)
Bell Object Relations and Reality Testing Inventory
Time frame: week 0 (baseline)
Meta-cognitions Questionnaire
Time frame: week 0 (baseline)
Five Facet Mindfulness Questionnaire
Time frame: week 0 (baseline)
Satisfaction With Life Scale
Time frame: week 0 (baseline)
Credibility/Expectancy Questionnaire
Time frame: week 0 (baseline)
Symptoms Checklist
Time frame: week 12 (end of treatment)
Self-Esteem Scale
Time frame: week 12 (end of treatment)
Defense Style Questionnaire
Time frame: week 12 (end of treatment)
Personality Beliefs Questionnaire
Time frame: week 12 (end of treatment)
Inventory of Interpersonal Problems
Time frame: week 12 (end of treatment)
Dysfunctional Working Models Scale
Time frame: week 12 (end of treatment)
Experiences in Close Relationships
Time frame: week 12 (end of treatment)
Bell Object Relations and Reality Testing Inventory
Time frame: week 12 (end of treatment)
Meta-cognitions Questionnaire
Time frame: week 12 (end of treatment)
Five Facet Mindfulness Questionnaire
Time frame: week 12 (end of treatment)
Satisfaction With Life Scale
Time frame: week 12 (end of treatment)
Self-Esteem Scale
Time frame: week 24 (follow-up)
Defense Style Questionnaire
Time frame: week 24 (follow-up)
Personality Beliefs Questionnaire
Time frame: week 24 (follow-up)
Inventory of Interpersonal Problems
Time frame: week 24 (follow-up)
Dysfunctional Working Models Scale
Time frame: week 24 (follow-up)
Experiences in Close Relationships
Time frame: week 24 (follow-up)
Bell Object Relations and Reality Testing Inventory
Time frame: week 24 (follow-up)
Meta-cognitions Questionnaire
Time frame: week 24 (follow-up)
Five Facet Mindfulness Questionnaire
Time frame: week 24 (follow-up)
Satisfaction With Life Scale
Time frame: week 24 (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
- Derived from this study: PubMed 32880104Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 26220089Suszek H, Holas P, Wyrzykowski T, Lorentzen S, Kokoszka A. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:319. doi: 10.1186/s13063-015-0827-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Kokoszka, MD, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Group Analytic Psychotherapy and Intensive transdiagnostic cognitive-behavioral group therapy in people with Anxiety Disorders and Depressive Disorders, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Kokoszka, MD, PhD (+48603128361, andrzej.kokoszka@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (time frame: week 0 (baseline)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126787, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.