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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | OTHER |
| University of Copenhagen | OTHER |
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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. 31st July 2018 suppl: Inclusion number expanded to 170 in each arm due to unexpected large drop-out.
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.31st July 2018 suppl: Inclusion number expanded to 340 due to unexpected large drop-out.
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 MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UP-CBT | Experimental | The "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP) is one of the most widely studied transdiagnostic manuals. Here, the investigators apply a group manual that has been modified from the published UP for individual therapy based on recommendations on group delivery from the UP Institute (personal communications) and integrations modifications necessary for the delivery in the Mental Health Service. Group UP-CBT, consist of 8 treatment modules delivered in 14 group sessions given weekly in 2 hour sessions. |
|
| Standard-CBT | Active Comparator | Group CBT following Danish versions of diagnosis specific manuals (Social Anxiety Disorder (SAD) Group; Depression (DEP) Group; Agoraphobia/Panic Disorder (Ag/PD) (standard-CBT). The original elements of psychoeducation, cognitive restructuring, and exposure/activity scheduling are present in the applied manuals. Standard-CBT, consist of 8 treatment modules delivered in 14 group sessions given weekly in 2 hour sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UP-CBT | Behavioral | Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| WHO Well-Being Index (WHO-5) | Self-rating questionnaire, 5 items on positive quality of life, web-based | Week 19 after allocation |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Symptom Check List (SCL-25) | Validated questionnaire - web-based | Week 19 after allocation |
| Work and Social Adjustment Scale (WSAS) | Validated questionnaire - web-based |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale (OASIS) | Validated questionnaire | Weekly, weeks 4-19 after allocation, before session |
| Overall Depression Severity and Impairment Scale (ODSIS) | Validated questionnaire |
Inclusion Criteria:
Referred to Danish Mental Health Service
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sidse MH Arnfred, MD,PhD,DMSc | Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychotherapeutic Unit, Mental Health Centre Copenhagen | Copenhagen | Capital Region | 2200 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27705086 | Background | Reinholt N, Aharoni R, Winding C, Rosenberg N, Rosenbaum B, Arnfred S. Transdiagnostic group CBT for anxiety disorders: the unified protocol in mental health services. Cogn Behav Ther. 2017 Jan;46(1):29-43. doi: 10.1080/16506073.2016.1227360. Epub 2016 Oct 5. | |
| 24646219 | Background | Reinholt N, Krogh J. Efficacy of transdiagnostic cognitive behaviour therapy for anxiety disorders: a systematic review and meta-analysis of published outcome studies. Cogn Behav Ther. 2014;43(3):171-84. doi: 10.1080/16506073.2014.897367. Epub 2014 Mar 19. |
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The datasets generated by the planned study will not be publicly available due to the rules of the Danish Data Protection Agency, but will be available from the corresponding author, after publication, on reasonable request and following signed confidentiality agreement with PI and the Danish Data Protection Agency Region Zealand.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2016 | Apr 11, 2019 |
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| Standard-CBT | Behavioral | Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy |
|
| Week 19 after allocation |
| Hamilton Depression Rating Scale (HDRS) | 6-item HDRS based on telephone interview | Week 19 after allocation |
| Hamilton Anxiety Rating Scale (HARS) | 6-item HARS based on telephone interview | Week 19 after allocation |
| Weekly, weeks 4-19 after allocation, before session |
| WHO Well-Being Index (WHO-5) | Validated questionnaire | Weekly, weeks 4-19 after allocation, before session |
| Positive Affect and Negative Affect Schedule (PANAS) | Validated questionnaire - web-based | Week 19 after allocation |
| Positive Affect and Negative Affect Schedule (PANAS) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Hopkins Symptom Check List (SCL-25) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Emotion Regulation Questionnaire (ERQ) | Validated questionnaire - web-based | Week 19 after allocation |
| Emotion Regulation Questionnaire (ERQ) | Validated questionnaire - web-based | Week 42-43 after allocation |
| WHO Well-Being Index (WHO-5) | Self-rating questionnaire, 5 items on positive quality of life, web-based | Week 42-43 after allocation |
| Emotion Regulation Strategies Questionnaire (ERSQ) | Validated questionnaire - web-based | Week 19 after allocation |
| Emotion Regulation Strategies Questionnaire (ERSQ) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Perseverative Thinking Questionnaire (PTQ) | Validated questionnaire - web-based | Week 19 after allocation |
| Perseverative Thinking Questionnaire (PTQ) | Validated questionnaires - web-based | Week 42-43 after allocation |
| Becks Depression inventory (BDI-II) | Validated questionnaire - web-based | Week 19 after allocation |
| Becks Depression inventory (BDI-II) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Work and Social Adjustment Scale (WSAS) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores | Validated questionnaire - web-based | Week 19 after allocation |
| Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores | Validated questionnaire - web-based | Week 42-43 after allocation |
| Liebowitch Social Anxiety Scale (LSAS) | Validated questionnaire - web-based | Week 19 after allocation |
| Liebowitch Social Anxiety Scale (LSAS) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Panic Disorder Severity Scale (PDSS) | Validated questionnaire - web-based | Week19 after allocation |
| Panic Disorder Severity Scale (PDSS) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Mobility Inventory for Agoraphobia (MIA) | Validated questionnaire - web-based | Week 19 after allocation |
| Mobility Inventory for Agoraphobia (MIA) | Validated questionnaire - web-based | Week 42-43 after allocation |
| Hamilton Depression Rating Scale | 6-item HDRS based on telephone interview | Week 42-43 after allocation |
| Hamilton Anxiety Rating Scale | 6-item HARS based on telephone interview | Week 42-43 after allocation |
| Client Satisfaction Questionnaire | 8-item validated questionnaire, web-based | Week 43 |
| Patient Evaluation of Group Therapy | Purpose-made questionnaire | Week 19 |
| Group Questionnaire - brief | 8 items from validated questionnaire about group atmosphere | Weekly, weeks 4-19 after allocation, after session |
| Therapist Ratings of session methods and atmosphere | Purpose-made questionnaire | Weekly, weeks 4-19 after allocation, after session |
| Homework and Event Tracker | Purpose-made question for patients about homework and events previous week | Weekly, weeks 4-19 after allocation, before session |
| Outpatient Clinic for Anxiety and Personality Disorders |
| Risskov |
| Central Region |
| 8240 |
| Denmark |
| Outpatient Clinic for Mania and Depression | Risskov | Central Region | 8240 | Denmark |
| Psychiatric Outpatient Clinic | Slagelse | Region Sjælland | 4200 | Denmark |
| 22697453 | Background | Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18. |
| 20886609 | Background | Wilamowska ZA, Thompson-Hollands J, Fairholme CP, Ellard KK, Farchione TJ, Barlow DH. Conceptual background, development, and preliminary data from the unified protocol for transdiagnostic treatment of emotional disorders. Depress Anxiety. 2010 Oct;27(10):882-90. doi: 10.1002/da.20735. |
| 37106559 | Derived | Niemeijer M, Reinholt N, Poulsen S, Bach B, Christensen AB, Eskildsen A, Hvenegaard M, Arendt M, Arnfred S. Trait and symptom change in group cognitive behaviour therapy for anxiety and depression. Clin Psychol Psychother. 2023 Sep-Oct;30(5):1058-1070. doi: 10.1002/cpp.2857. Epub 2023 Apr 27. |
| 28114915 | Derived | Arnfred SM, Aharoni R, Hvenegaard M, Poulsen S, Bach B, Arendt M, Rosenberg NK, Reinholt N. Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial. BMC Psychiatry. 2017 Jan 23;17(1):37. doi: 10.1186/s12888-016-1175-0. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Aug 19, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
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