Personality DisorderNCT06591754
Feasibility, Acceptability, and Preliminary Effects of ISTDP for Personality Disorders in a Specialized Psychiatric Clinic
A study testing ISTDP in people with Personality Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personality Disorder
- What is being tested?
- ISTDP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Personality disorder diagnosis (Clinical assessment using STIP-5) Speaks Swedish fluently
Who cannot join
- Autism or intellectual disability Borderline, antisocial or narcissistic personality disorder diagnosis Need for interpreter Urgent social misery Psychotic disorder High suicidality
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst
Stockholm, 14157
About this study
Official title: A Pilotstudy Investigating Feasability, Acceptability and Preliminary Effects of ISTDP (Intensive Short Term Dynamic Psychotherapy) for Patients with Personality Disorder in a Psychiatric Clinic Specialized on Depression, Anxiety and PTSD
The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.
Read the detailed description
The investigators vill investigate a 25-week treatment with ISTDP that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and PTSD. The feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. Patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.
- Conditions
- Personality Disorder
- Being tested
- ISTDP
- Keywords
- Personality disorder, ISTDP, Intensive Short-Term Dynamic Psychotherapy
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISTDPBehavioural
Both the individual therapy and the group therapy is based on ISTDP (Intensive Short-Term Dynamic Psychotherapy), an affect-focused psychodynamic therapy method. The therapy focus on the relationship between feelings, anxiety and dysfunctional emotion regulation (i.e. defenses). The purpose is to increase the capacity of anxiety regulation in the patient and to help the patient identify the dysfunctional patterns developed to avoid internal stress and then gradually approach previously warded of feelings. The individual therapy consists of 25 weekly sessions. The group treatment consists of 18 weekly sessions and is structured in three phases. Phase one: Psychoeducation about anxiety and exercises in anxiety regulation. Phase two: patients takes turn to observe their own anxiety and defenses together with a therapist. Phase three: Every session two patients will work with a chosen problem and identify defenses, anxiety and feelings together with a therapist in front of the group.
| Study group | Role | What they receive |
|---|---|---|
| ISTDP | Experimental | ISTDP combined group- and individual therapy Receives: Behavioral: ISTDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews
Measured: Immediately after treatment completion
Depression symtoms
Depression symtoms will be measured with Patient Health Questionnaire (PHQ-9; (Kroenke et al., 2001)
Measured: Baseline, weekly throughout treatment, immediately after treatment completion and 6-month follow-up
Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)
Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)
Measured: Immediately after treatment completion (25 weeks)
Adverse events related to the treatment
Adverse events related to the treatment
Measured: From start of treatment up to. 6 month follow up.
Number of individual sessions attended during the treatment
Number of individual sessions attended during the treatment
Measured: Throughout the treatment period, up to 25 weeks
Number of group sessions attended during the treatment
Number of group sessions attended during the treatment
Measured: Throughout the treatment period, up to 25 weeks
Number of dropouts
Number of dropouts
Measured: Throughout the treatment period, up to 25 weeks
Total number of sessions attended during the treatment
Total number of sessions attended during the treatment
Measured: Throughout the treatment period, up to 25 weeks
Secondary outcomes (10)
Fear of negative emotions
Fear of negative emotion scale (Gilbert et al., 2014) for assessing fear and avoidance of negative feelings.
Measured: Change from baseline to post-treatment (25 weeks) and follow up 6 months after treatment.
Anxiety symtoms
Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006) for assessing anxiety symtoms.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Emotions regulation difficulties
Difficulties in Emotion Regulation Scale (DERS-16; Bjureberg et al., 2016) for assessing difficulties with emotions regulation.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Severity of personality disorder
The Standardized Assessment of Severity of Personality Disorders (SASPD; Olajide et al., 2018) for assessing degree of personality disorder.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Symtoms of Borderline Personality disorder
Borderline Symtom List (BLS-23; Bohus et al., 2008) for assessing symtoms of Borderline personality disorder.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Severity of personality disorder
Levels of Personality Functioning Brief Form (LPFS-BF; Weekers et al., 2019) for assessing degree of personality disorder.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Quality of life
Brunnsviken Brief Quality of life (Lindner et al., 2016) for assessing quality of life.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Quality of life
EuroQol-5D (EQ5D; Balestroni, Gianluigi, \& Bertolotti, 2015) for assessing quality of life.
Measured: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Working alliance
Session Alliance Inventory (SAI; Falkenström et al., 2015) for assessing the working alliance with the therapist
Measured: Weekly throughout treatment , up to 25 weeks
Emotional activation during therapy
Emotional Experience Self Report (Fisher et al., 2016) for assessing the degree of emotional activation during the session.
Measured: Weekly throughout treatment, up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Stockholm University
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591754
- Sponsor's protocol ID
- 2024-04361-01
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The raw data collected in the study can be made available on a group level given that the request comply with Swedish and EU laws regulating protection of identifiable data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilotstudy Investigating Feasability, Acceptability and Preliminary Effects of ISTDP (Intensive Short Term Dynamic Psychotherapy) for Patients with Personality Disorder in a Psychiatric Clinic Specialized on Depression, Anxiety and PTSD
- ClinicalTrials.gov ID
- NCT06591754
- Acronym / sponsor ID
- 2024-04361-01
- Conditions
- Personality Disorder
- Keywords
- Personality disorder, ISTDP, Intensive Short-Term Dynamic Psychotherapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Stockholm University
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
The primary objective of this study is to evaluate the feasibility and acceptability of a 25-week combined group and individual therapy program using Intensive Short-Term Dynamic Psychotherapy (ISTDP) for patients diagnosed with personality disorders. The secondary objective is to investigate preliminary effects of the treatment in terms of reducing symtoms of depression, anxiety and emotion regulation difficulties.
Detailed description
The investigators vill investigate a 25-week treatment with ISTDP that consists of both weekly group- and individual therapy for patients diagnosed with personality disorder in a psychiatric clinic specialized on depression, anxiety and PTSD. The feasibility and acceptability and preliminary effects will be evaluated using a within-group design with repeated measures and qualitative interviews. Patients will be recruited from the clinic and the main inclusion criteria is that the patient have a personality disorder diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISTDP | Experimental | Behavioral: ISTDPISTDP combined group- and individual therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Personality disorder diagnosis (Clinical assessment using STIP-5) Speaks Swedish fluently
Key exclusion criteria (1 listed)
- Autism or intellectual disability Borderline, antisocial or narcissistic personality disorder diagnosis Need for interpreter Urgent social misery Psychotic disorder High suicidality
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 |
|---|---|---|
| ISTDPBoth the individual therapy and the group therapy is based on ISTDP (Intensive Short-Term Dynamic Psychotherapy), an affect-focused psychodynamic therapy method. The therapy focus on the relationship between feelings, anxiety and dysfunctional emotion regulation (i.e. defenses). The purpose is to increase the capacity of anxiety regulation in the patient and to help the patient identify the dysfunctional patterns developed to avoid internal stress and then gradually approach previously warded of feelings. The individual therapy consists of 25 weekly sessions. The group treatment consists of 18 weekly sessions and is structured in three phases. Phase one: Psychoeducation about anxiety and exercises in anxiety regulation. Phase two: patients takes turn to observe their own anxiety and defenses together with a therapist. Phase three: Every session two patients will work with a chosen problem and identify defenses, anxiety and feelings together with a therapist in front of the group. | Behavioural | ISTDP |
Primary outcome
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews
Time frame: Immediately after treatment completion
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews
Depression symtoms
Time frame: Baseline, weekly throughout treatment, immediately after treatment completion and 6-month follow-up
Depression symtoms will be measured with Patient Health Questionnaire (PHQ-9; (Kroenke et al., 2001)
Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)
Time frame: Immediately after treatment completion (25 weeks)
Participants satisfaction with treatment assessed with the Client Satisfaction Questionnaire (CSQ-8)
Adverse events related to the treatment
Time frame: From start of treatment up to. 6 month follow up.
Adverse events related to the treatment
Number of individual sessions attended during the treatment
Time frame: Throughout the treatment period, up to 25 weeks
Number of individual sessions attended during the treatment
Number of group sessions attended during the treatment
Time frame: Throughout the treatment period, up to 25 weeks
Number of group sessions attended during the treatment
Number of dropouts
Time frame: Throughout the treatment period, up to 25 weeks
Number of dropouts
Total number of sessions attended during the treatment
Time frame: Throughout the treatment period, up to 25 weeks
Total number of sessions attended during the treatment
10 secondary outcomes
Fear of negative emotions
Time frame: Change from baseline to post-treatment (25 weeks) and follow up 6 months after treatment.
Anxiety symtoms
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Emotions regulation difficulties
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Severity of personality disorder
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Symtoms of Borderline Personality disorder
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Severity of personality disorder
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Quality of life
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Quality of life
Time frame: Change from baseline to immediately after treatment completion (25 weeks) and follow up 6 months after treatment.
Working alliance
Time frame: Weekly throughout treatment , up to 25 weeks
Emotional activation during therapy
Time frame: Weekly throughout treatment, up to 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. The raw data collected in the study can be made available on a group level given that the request comply with Swedish and EU laws regulating protection of identifiable data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISTDP in people with Personality Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 19 Sep 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients experience of, and satisfaction with, the treatment assessed through qualitative interviews (time frame: Immediately after treatment completion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.