Emotional DisorderNCT03064477
The Unified Protocol for the Treatment of Emotional Disorders in Spanish Public Mental Health System
A study testing Unified Protocol and Cognitive Behavioral Therapy (TAU) in people with Emotional Disorder and Anxiety Disorders, run by Universitat Jaume I at 3 sites in Spain.
Trial summary
The present randomized, controlled trial will compare the cost-efficacy and acceptability of the Unified Protocol in group format against traditional individual Cognitive Behavioral Treatment in a sample of patients with emotional disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- What is being tested?
- Unified Protocol and Cognitive Behavioral Therapy (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesSpain
- Study dates
- 14 Sep 2014to 30 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anxiety or mood disorder is the main diagnosis
- The patient is over 18 years of age
- The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
- The patient is able to attend to the evaluation and treatment sessions
- The patient signs the informed consent form
Who cannot join
- The patient presents a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder) or there is suicide risk at the time of assessment
- The patient has used substances in the last three months (excluding cannabis, coffee, and / or nicotine)
- The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable CBT principles
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario de Elda
Elda
Alejandro Lizaur Utrilla, 961622300
Lorena Pallás Álvarez
- Recruiting
Clínica de Navarra
Pamplona
Olga Díaz Pardo, 848422495
Luisa Fernanda Pérez Ayerra
- Recruiting
Hospital Comarcal de Vinaròs
Vinaròs
Benjamin Altozano, MD, 964477000
Vanessa Ferreres Galan
About this study
Official title: Cost-efficacy and Acceptability of the Unified Protocol for the Treatment of Emotional Disorders in the Spanish Public Mental Health System Using a Group Format
The present randomized, controlled trial will compare the cost-efficacy and acceptability of the Unified Protocol in group format against traditional individual Cognitive Behavioral Treatment in a sample of patients with emotional disorders. Ultimately, the goal of the current study is to explore whether the Unified Protocol in group format can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System, that is, one that generates long-lasting changes in symptoms, while reducing both direct and indirect economic costs associated with the treatment of emotional disorders.
Read the detailed description
Emotional disorders (EDs; i.e., depressive and anxiety disorders) have become the most prevalent psychiatric disorders globally. The 12-month prevalence of anxiety and depressive disorders affect 14% and 7.8% (6.9% by major depression) of the population, respectively, and comordibity may be as high as 50%. Lifetime prevalence rates in primary care settings in Spain reveal that mood and anxiety disorders, as defined in the DSM-IV-TR, are the most prevalent psychiatric problems as well, with 35.8% and 25.6%, respectively.
As a result of their high prevalence in the population, emotional disorders have become a global health problem due to their associated costs.For instance, a study conducted in 36 countries estimated that the annual cost of treatment for depressive disorders and anxiety problems amounted to $91 billion and $56 billion, respectively. If both direct and indirect costs of these emotional disorders were accounted for, expenses increased to $925,000 million. In Spain, when both direct and indirect costs are included, mood and anxiety disorders are estimated to cost €10,763 million and €10,365 million, respectively.
Pharmacological treatment and individual cognitive behavioral therapy (CBT) are the most frequent interventions for emotional disorders in the Spanish National Health System. Therefore, increasing the efficiency of these treatments may be a way of reducing the current public health costs of emotional disorders. A recently developed form of CBT, the Unified Protocol for the Treatment of Emotional Disorders (UP), might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The UP was created on the basis of the identification of common psychopathological vulnerability factors in emotional disorders, together with elements and techniques shared by disorder-specific cognitive-behavioral treatments. In the UP, traditional CBT techniques (i.e., cognitive restructuring) and contemporary practices (i.e., mindfulness) are combined to treat emotion regulation deficits, which are argued to be the underlying common factor in all emotional disorders. The UP is a structured, manual-based treatment, so it can be easily applied in a group format. This, together with the fact that the UP can be applied simultaneously to individuals with different emotional disorders, might help reduce existent waiting lists and current costs of individual treatment.
So far, studies exploring the effectiveness of the UP in a group format have led to promising findings. Overall, results suggest that the UP has between moderate and strong effect sizes on numerous outcomes, including depression, anxiety, positive and negative affect, quality of life, overall adjustment, and avoidance of negative sensations, for both anxiety and mood disorders. These studies have also revealed that between half and two thirds of patients ceased to meet diagnostic criteria after the treatment and one investigation, conducted by the investigators participating in the present study, revealed that changes remained stable 12 months after treatment completion. Despite the previous results are encouraging, conclusions should be interpreted with caution as sample sizes have been small (11 participants in two studies and 47 patients in one investigation) and cost-effectiveness of the UP in group format compared with traditional individual CBT remains unclear. Methodologically-sound, randomized, controlled trials are needed in order to replicate the aforementioned findings and to elucidate whether the UP in group format is an effective and efficient treatment option for emotional disorders in public settings.
It is expected that both interventions (CBT and UP) will be comparable in terms of effectiveness and acceptability, but treatment costs will be lower in the UP condition. To ensure the generalizability of results, the hypotheses will be tested in various public mental health centers in Spain.
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Being tested
- Unified Protocol, Cognitive Behavioral Therapy (TAU)
- Keywords
- Unified Protocol, Transdiagnostic approach, Public health
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
Intervention group that carries out the Unified Protocol in a group format
Cognitive Behavioral Therapy (TAU)Behavioural
TAU group that carries out Cognitive Behavioral Therapy in an individual format
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol (UP) | Experimental | Investigators in the present study have adapted the UP to implement it in group format in a Public Mental Health setting in Spain. This adaptation is composed of 12 treatment sessions of two hours of duration each, at a rate of one per week.
Participants in the UP will receive UP treatment in group format instead of the usual Cognitive Behavioral Therapy in individual format. Patients in the UP condition will receive pharmacological treatment (i.e., antidepressants and / or anxiolytics) as usual. Receives: Behavioral: Unified Protocol |
| Treatment As Usual (TAU) | Active comparator | Cognitive Behavioral Therapy in individual format is the treatment of choice (TAU) by psychologists and psychiatrists at the collaborating Public Mental Health Centers and Primary Care Centers, together with pharmacological treatment (i.e., antidepressants and / or anxiolytics). Receives: Behavioral: Cognitive Behavioral Therapy (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of depressive symptoms
The Beck Depression Inventory-II (BDI-II) is a largely used measure that evaluates depressive symptomatology. It consists of 21 items, each including a set of four different sentences that reflect an increasing degree of depression. Responses are obtained through a 4-point Likert scale ranging from 0 (lowest degree of depressive symptomatology) to 3 (most severe symptomatology). Scores in the BDI-II range from 0 to 63. The alpha coefficient obtained in the Spanish version (.87) indicates a good internal consistency.
Measured: Up to 12 months
Change in the severity of anxiety symptoms
The Beck Anxiety Inventory (BAI) is a frequently used measure of the severity of anxiety symptoms. The BAI includes 21 items. Each item reflects an anxiety symptom and respondents are asked to rate the extent to which the symptoms affected them during the past week. Responses are obtained through a 4-point Likert scale ranging from 0 = not at all to 3 = severely. Total score ranges from 0 to 63. The internal consistency estimate for the Spanish version of the BAI is high (.93).
Measured: Up to 12 months
Secondary outcomes (8)
Change in quality of life
The Quality of Life Index (QLI) is a self-report measure composed of 10 items, each representing a dimension of quality of life: physical disability, emotional well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, social emotional support, community and services support, personal fulfillment, spiritual fulfillment, and overall quality of life. Responses are obtained be means of a 10-point line ranging from 0 = poor to 10 = excellent. Test-retest reliability of the Spanish version of the QLI (QLI-Sp) is very good (.89).
Measured: Up to 12 months
Change in the general tendency to worry
The Penn State Worry Questionnaire (PSWQ) was administered to patients with general anxiety disorders. It evaluates an individuals' general tendency to worry excessively. It contains 16 items that assess the intensity and frequency of preoccupation where 1 = nothing and 5 = much. The PSWQ has an excellent internal consistency (.95).
Measured: Up to 12 months
Change in obsessions and compulsions
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a semi-structured interview is used to evaluate the severity of obsessions and compulsions of patients with obsessive-compulsive disorders. It consists of 64 items, which are then grouped into 15 categories. The categories evaluate the duration, interference, discomfort, resistance, and control over obsessions and compulsions using a scale ranging from 0 = absence of symptoms to 4 = extreme severity of symptoms. The Y-BOCS has a very good internal consistency (.60-.91).
Measured: Up to 12 months
Change in the severity of panic symptoms
The Self-reported Panic Disorder Severity Scale (PDSS-SR) evaluates the severity of symptoms in persons with panic disorders (intensity, frequency, interference, avoidance, and agoraphobic fear, among others) using a semi-structured interview. Seven Likert-type items are administered each with a 0-4 range (0 = minimum severity of symptoms and 4 = maximum severity of symptoms). The internal consistency of this instrument is good (.65).
Measured: Up to 12 months
Change in agoraphobia severity
The Inventory for Agoraphobia (IA) examines the physiological, motor, and cognitive responses of agoraphobia patients, both when they are alone and accompanied. It consists of 69 Likert-type items. The internal consistency is high for the three subscales: physiological responses (0.94), motor responses (0.93), and cognitive responses (0.87).
Measured: Up to 12 months
Change in the severity of post-traumatic symptoms
The Post-Traumatic Stress Disorder Symptom Severity Scale (PTSD-SSS) is used to assess the severity of symptoms in people who have experienced a traumatic life event. It contains 17 items that are classified into 3 subscales: re-experimentation, avoidance, and activation increase. The internal consistency of the scale is excellent (.92).
Measured: Up to 12 months
Change in social anxiety symptoms
The Social interaction anxiety inventory (SIAS) is a self-reported scale assesses fear and anxiety in social interactions. It consists of 19 items that refer to the severity of symptoms, where 0 indicates nothing and 4 indicates very. The SIAS has excellent reliability estimates (.90).
Measured: Up to 12 months
Change in the severity of hypochondriacal attitudes
The Whiteley Index of hypochondriasis (WI) consists of 14 dichotomous items, labeled yes and no, that evaluate hypochondriacal attitudes. Items are grouped into 3 subscales: bodily concern, phobia to diseases, and conviction of the presence of a disease. The internal consistency of scales in the WI is very good (.76 - .80).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start14 Sep 2014
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- All consecutive patients with emotional disorders attending any of the collaborating centers will be asked to participate in the present study. Once inclusion criteria are met, each patient will be randomly assigned to one of the two experimental groups: TAU or UP. Randomization will be performed by a researcher unrelated to the study using a computer-generated sequence (Randomizer). Randomization will be stratified according to the severity of the primary measures of depression and anxiety, using the recommended cutoff in the manuals. Stratification will be made to ensure a comparable proportion of severely depressed and anxious individuals in each group. For each subgroup (i.e., severe or less severe depression and/or anxiety), participants will be randomly assigned to the UP or to TAU.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Zaragoza
- Responsible party
- Sponsor
- Investigators
- Jorge Osma, Ph.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064477
- Sponsor's protocol ID
- UJIUP
- Status last verified
- Jun 2020
- First submitted
- 22 Feb 2017
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta y manual del paciente.[The unified protocol for transdiagnostic treatment of emotional disorders: Client workbook and Therapist guide]. Madrid: Alianza Editorial; 2015.
Beck AT, Steer R. Beck Anxiety Inventory manual. San Antonio: Psychological Corporation;1993.
Gallagher MW, Sauer-Zavala SE, Boswell JF, Carl JR, Bullis J, Farchione TJ, Barlow DH. The Impact of the Unified Protocol for Emotional Disorders on Quality of Life. Int J Cogn Ther. 2013 Mar 1;6(1):10.1521/ijct.2013.6.1.57. doi: 10.1521/ijct.2013.6.1.57.
PubMed 24358405Osma J, Barrada JR, Garcia-Palacios A, Navarro-Haro M, Aguilar A. Internal Structure and Clinical Utility of the Anxiety Control Questionnaire-Revised (ACQ-R) Spanish Version. Span J Psychol. 2016 Oct 3;19:E63. doi: 10.1017/sjp.2016.69.
PubMed 27692017Osma J, Castellano C, Crespo E, García-PalaciosA. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in format group in a Spanish public mental health setting. PsicologíaConductual. 2015; 23 (3): 447-466.
Carl JR, Gallagher MW, Sauer-Zavala SE, Bentley KH, Barlow DH. A preliminary investigation of the effects of the unified protocol on temperament. Compr Psychiatry. 2014 Aug;55(6):1426-34. doi: 10.1016/j.comppsych.2014.04.015. Epub 2014 Apr 27.
PubMed 24933653Peris-Baquero O, Osma J. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Group Format in Spain: Results of a Noninferiority Randomized Controlled Trial at 15 Months after Treatment Onset. Depress Anxiety. 2023 Jun 30;2023:1981377. doi: 10.1155/2023/1981377. eCollection 2023.
PubMed 40224586Osma J, Peris-Baquero O, Suso-Ribera C, Farchione TJ, Barlow DH. Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Psychother Res. 2022 Mar;32(3):329-342. doi: 10.1080/10503307.2021.1939190. Epub 2021 Jun 16.
PubMed 34132170Osma J, Suso-Ribera C, Garcia-Palacios A, Crespo-Delgado E, Robert-Flor C, Sanchez-Guerrero A, Ferreres-Galan V, Perez-Ayerra L, Malea-Fernandez A, Torres-Alfosea MA. Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial. Health Qual Life Outcomes. 2018 Mar 12;16(1):46. doi: 10.1186/s12955-018-0866-2.
PubMed 29530035
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-efficacy and Acceptability of the Unified Protocol for the Treatment of Emotional Disorders in the Spanish Public Mental Health System Using a Group Format
- ClinicalTrials.gov ID
- NCT03064477
- Acronym / sponsor ID
- UJIUP
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Keywords
- Unified Protocol, Transdiagnostic approach, Public health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Universidad de Zaragoza
- Study start
- 14 Sep 2014 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Feb 2017 (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 present randomized, controlled trial will compare the cost-efficacy and acceptability of the Unified Protocol in group format against traditional individual Cognitive Behavioral Treatment in a sample of patients with emotional disorders. Ultimately, the goal of the current study is to explore whether the Unified Protocol in group format can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System, that is, one that generates long-lasting changes in symptoms, while reducing both direct and indirect economic costs associated with the treatment of emotional disorders.
Detailed description
Emotional disorders (EDs; i.e., depressive and anxiety disorders) have become the most prevalent psychiatric disorders globally. The 12-month prevalence of anxiety and depressive disorders affect 14% and 7.8% (6.9% by major depression) of the population, respectively, and comordibity may be as high as 50%. Lifetime prevalence rates in primary care settings in Spain reveal that mood and anxiety disorders, as defined in the DSM-IV-TR, are the most prevalent psychiatric problems as well, with 35.8% and 25.6%, respectively.
As a result of their high prevalence in the population, emotional disorders have become a global health problem due to their associated costs.For instance, a study conducted in 36 countries estimated that the annual cost of treatment for depressive disorders and anxiety problems amounted to $91 billion and $56 billion, respectively. If both direct and indirect costs of these emotional disorders were accounted for, expenses increased to $925,000 million. In Spain, when both direct and indirect costs are included, mood and anxiety disorders are estimated to cost €10,763 million and €10,365 million, respectively.
Pharmacological treatment and individual cognitive behavioral therapy (CBT) are the most frequent interventions for emotional disorders in the Spanish National Health System. Therefore, increasing the efficiency of these treatments may be a way of reducing the current public health costs of emotional disorders. A recently developed form of CBT, the Unified Protocol for the Treatment of Emotional Disorders (UP), might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format. The UP was created on the basis of the identification of common psychopathological vulnerability factors in emotional disorders, together with elements and techniques shared by disorder-specific cognitive-behavioral treatments. In the UP, traditional CBT techniques (i.e., cognitive restructuring) and contemporary practices (i.e., mindfulness) are combined to treat emotion regulation deficits, which are argued to be the underlying common factor in all emotional disorders. The UP is a structured, manual-based treatment, so it can be easily applied in a group format. This, together with the fact that the UP can be applied simultaneously to individuals with different emotional disorders, might help reduce existent waiting lists and current costs of individual treatment.
So far, studies exploring the effectiveness of the UP in a group format have led to promising findings. Overall, results suggest that the UP has between moderate and strong effect sizes on numerous outcomes, including depression, anxiety, positive and negative affect, quality of life, overall adjustment, and avoidance of negative sensations, for both anxiety and mood disorders. These studies have also revealed that between half and two thirds of patients ceased to meet diagnostic criteria after the treatment and one investigation, conducted by the investigators participating in the present study, revealed that changes remained stable 12 months after treatment completion. Despite the previous results are encouraging, conclusions should be interpreted with caution as sample sizes have been small (11 participants in two studies and 47 patients in one investigation) and cost-effectiveness of the UP in group format compared with traditional individual CBT remains unclear. Methodologically-sound, randomized, controlled trials are needed in order to replicate the aforementioned findings and to elucidate whether the UP in group format is an effective and efficient treatment option for emotional disorders in public settings.
It is expected that both interventions (CBT and UP) will be comparable in terms of effectiveness and acceptability, but treatment costs will be lower in the UP condition. To ensure the generalizability of results, the hypotheses will be tested in various public mental health centers in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All consecutive patients with emotional disorders attending any of the collaborating centers will be asked to participate in the present study. Once inclusion criteria are met, each patient will be randomly assigned to one of the two experimental groups: TAU or UP. Randomization will be performed by a researcher unrelated to the study using a computer-generated sequence (Randomizer). Randomization will be stratified according to the severity of the primary measures of depression and anxiety, using the recommended cutoff in the manuals. Stratification will be made to ensure a comparable proportion of severely depressed and anxious individuals in each group. For each subgroup (i.e., severe or less severe depression and/or anxiety), participants will be randomly assigned to the UP or to TAU.
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol (UP) | Experimental | Behavioral: Unified ProtocolInvestigators in the present study have adapted the UP to implement it in group format in a Public Mental Health setting in Spain. This adaptation is composed of 12 treatment sessions of two hours of duration each, at a rate of one per week. Participants in the UP will receive UP treatment in group format instead of the usual Cognitive Behavioral Therapy in individual format. Patients in the UP condition will receive pharmacological treatment (i.e., antidepressants and / or anxiolytics) as usual. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Cognitive Behavioral Therapy (TAU)Cognitive Behavioral Therapy in individual format is the treatment of choice (TAU) by psychologists and psychiatrists at the collaborating Public Mental Health Centers and Primary Care Centers, together with pharmacological treatment (i.e., antidepressants and / or anxiolytics). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Anxiety or mood disorder is the main diagnosis
- The patient is over 18 years of age
- The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
- The patient is able to attend to the evaluation and treatment sessions
- The patient signs the informed consent form
Key exclusion criteria (3 listed)
- The patient presents a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder) or there is suicide risk at the time of assessment
- The patient has used substances in the last three months (excluding cannabis, coffee, and / or nicotine)
- The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable CBT principles
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 |
|---|---|---|
| Unified ProtocolIntervention group that carries out the Unified Protocol in a group format | Behavioural | Unified Protocol (UP) |
| Cognitive Behavioral Therapy (TAU)TAU group that carries out Cognitive Behavioral Therapy in an individual format | Behavioural | Treatment As Usual (TAU) |
Primary outcome
Change in the severity of depressive symptoms
Time frame: Up to 12 months
The Beck Depression Inventory-II (BDI-II) is a largely used measure that evaluates depressive symptomatology. It consists of 21 items, each including a set of four different sentences that reflect an increasing degree of depression. Responses are obtained through a 4-point Likert scale ranging from 0 (lowest degree of depressive symptomatology) to 3 (most severe symptomatology). Scores in the BDI-II range from 0 to 63. The alpha coefficient obtained in the Spanish version (.87) indicates a good internal consistency.
Change in the severity of anxiety symptoms
Time frame: Up to 12 months
The Beck Anxiety Inventory (BAI) is a frequently used measure of the severity of anxiety symptoms. The BAI includes 21 items. Each item reflects an anxiety symptom and respondents are asked to rate the extent to which the symptoms affected them during the past week. Responses are obtained through a 4-point Likert scale ranging from 0 = not at all to 3 = severely. Total score ranges from 0 to 63. The internal consistency estimate for the Spanish version of the BAI is high (.93).
8 secondary outcomes
Change in quality of life
Time frame: Up to 12 months
Change in the general tendency to worry
Time frame: Up to 12 months
Change in obsessions and compulsions
Time frame: Up to 12 months
Change in the severity of panic symptoms
Time frame: Up to 12 months
Change in agoraphobia severity
Time frame: Up to 12 months
Change in the severity of post-traumatic symptoms
Time frame: Up to 12 months
Change in social anxiety symptoms
Time frame: Up to 12 months
Change in the severity of hypochondriacal attitudes
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- BackgroundBarlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta y manual del paciente.[The unified protocol for transdiagnostic treatment of emotional disorders: Client workbook and Therapist guide]. Madrid: Alianza Editorial; 2015.
- BackgroundBeck AT, Steer R. Beck Anxiety Inventory manual. San Antonio: Psychological Corporation;1993.
- Background: PubMed 24358405Gallagher MW, Sauer-Zavala SE, Boswell JF, Carl JR, Bullis J, Farchione TJ, Barlow DH. The Impact of the Unified Protocol for Emotional Disorders on Quality of Life. Int J Cogn Ther. 2013 Mar 1;6(1):10.1521/ijct.2013.6.1.57. doi: 10.1521/ijct.2013.6.1.57.
- Background: PubMed 27692017Osma J, Barrada JR, Garcia-Palacios A, Navarro-Haro M, Aguilar A. Internal Structure and Clinical Utility of the Anxiety Control Questionnaire-Revised (ACQ-R) Spanish Version. Span J Psychol. 2016 Oct 3;19:E63. doi: 10.1017/sjp.2016.69.
- BackgroundOsma J, Castellano C, Crespo E, García-PalaciosA. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in format group in a Spanish public mental health setting. PsicologíaConductual. 2015; 23 (3): 447-466.
- Background: PubMed 24933653Carl JR, Gallagher MW, Sauer-Zavala SE, Bentley KH, Barlow DH. A preliminary investigation of the effects of the unified protocol on temperament. Compr Psychiatry. 2014 Aug;55(6):1426-34. doi: 10.1016/j.comppsych.2014.04.015. Epub 2014 Apr 27.
- Derived from this study: PubMed 40224586Peris-Baquero O, Osma J. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Group Format in Spain: Results of a Noninferiority Randomized Controlled Trial at 15 Months after Treatment Onset. Depress Anxiety. 2023 Jun 30;2023:1981377. doi: 10.1155/2023/1981377. eCollection 2023.
- Derived from this study: PubMed 34132170Osma J, Peris-Baquero O, Suso-Ribera C, Farchione TJ, Barlow DH. Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Psychother Res. 2022 Mar;32(3):329-342. doi: 10.1080/10503307.2021.1939190. Epub 2021 Jun 16.
- Derived from this study: PubMed 29530035Osma J, Suso-Ribera C, Garcia-Palacios A, Crespo-Delgado E, Robert-Flor C, Sanchez-Guerrero A, Ferreres-Galan V, Perez-Ayerra L, Malea-Fernandez A, Torres-Alfosea MA. Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial. Health Qual Life Outcomes. 2018 Mar 12;16(1):46. doi: 10.1186/s12955-018-0866-2.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
Related trials for Emotional Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
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.
Jorge Osma, Ph.D. principal investigator
Assistant Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol and Cognitive Behavioral Therapy (TAU) in people with Emotional Disorder and Anxiety Disorders, run by Universitat Jaume I at 3 sites in Spain.
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 3 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 Jorge Osma, Ph.D. (976861390, osma@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the severity of depressive symptoms (time frame: Up to 12 months). The study lists 2 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 NCT03064477, which also lists 9 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 18 Jun 2020.