Clinical Trial: Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder: A Pragmatic, Multicenter Non-inferiority Randomized Contro
Brief Summary:
Transdiagnostic Cognitive Behavior Therapy (CBT) delivered in the individual format, have been proven just as effective as traditional diagnosis specific CBT manuals. The investigators have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) to make it applicable as group therapy in Danish Mental Health Service and a naturalistic trial of this manual has shown promising results. As the use of one manual instead of several diagnosis specific manuals in regional clinics could simplify logistics and reduce waiting time, the investigators want to compare group UP-CBT with diagnosis specific group CBT.
Method: A partial blinded, pragmatic, non-inferiority, multicentre randomized clinical trial (RCT). UP-CBT is compared to treatment-as-usual CT. 124 patients are included in each intervention arm, recruited from three Danish regional Mental Health Service Clinics.
Detailed Summary:
Background: Transdiagnostic Cognitive Behavior Therapy (TCBT) Manuals delivered in individual format, have been reported to be just as effective as traditional diagnosis specific CBT manuals. The investigators have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) developed by Barlow and colleagues for use in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic trial. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, the study aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT.
Methods/design: It is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for depression, social anxiety disorder and agoraphobia/panic disorder. In both arms, the intervention consists of weekly group session for 14 weeks. In total, 248 patients are recruited from three regional MHS centers across the country and included in two intervention arms.
Outcomes are measured at end of therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to delivered intervention, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence.
Discussion: The current study will be the first RCT investigating the dissemination of the UP in a MHS setting and UP delivered in groups and including patients with depression. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MH
Sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Current Primary Outcome: WHO Well-Being Index (WHO-5) [ Time Frame: Week 16-17 after allocation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- WHO Well-Being Index (WHO-5) [ Time Frame: Week 42-43 after allocation ]Self-rating questionnaire, 5 items on positive quality of life, web-based
- Positive Affect and Negative Affect Schedule (PANAS) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - webbased
- Positive Affect and Negative Affect Schedule (PANAS) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - webbased
- Hopkins Symptom Check List (SCL-25) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - webbased
- Hopkins Symptom Check List (SCL-25) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - webbased
- Emotion Regulation Questionnaire (ERQ) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Emotion Regulation Questionnaire (ERQ) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Emotion Regulation Strategies Questionnaire (ERSQ) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Emotion Regulation Strategies Questionnaire (ERSQ) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Perserverative Thinking Questionnaire (PTQ) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Perserverative Thinking Questionnaire (PTQ) [ Time Frame: Week 42-43 after allocation ]Validated questionnaires - web-based
- Becks Depression inventory (BDI-II) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Becks Depression inventory (BDI-II) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Work and Social Adjustment Scale (WSAS) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Work and Social Adjustment Scale (WSAS) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Liebowitch Social Anxiety Scale (LSAS) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Liebowitch Social Anxiety Scale (LSAS) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Panic Disorder Severity Scale (PDSS) [ Time Frame: Week16-17 after allocation ]Validated questionnaire - web-based
- Panic Disorder Severity Scale (PDSS) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Mobility Inventory for Agoraphobia (MIA) [ Time Frame: Week 16-17 after allocation ]Validated questionnaire - web-based
- Mobility Inventory for Agoraphobia (MIA) [ Time Frame: Week 42-43 after allocation ]Validated questionnaire - web-based
- Hamilton Depression Rating Scale [ Time Frame: Week 16-17 after allocation ]6-item HDRS based on telephone interview
- Hamilton Depression Rating Scale [ Time Frame: Week 42-43 after allocation ]6-item HDRS based on telephone interview
- Hamilton Anxiety Rating Scale [ Time Frame: Week 16-17 after allocation ]6-ite
Original Secondary Outcome: Same as current
Information By: Psychiatric Research Unit, Region Zealand, Denmark
Dates:
Date Received: October 25, 2016
Date Started: December 2016
Date Completion: April 2019
Last Updated: November 1, 2016
Last Verified: November 2016
