TRACT-RCT: Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder
Study Details
Study Description
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. 31st July 2018 suppl: Inclusion number expanded to 170 in each arm due to unexpected large drop-out.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UP-CBT 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. |
Behavioral: UP-CBT
Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy
|
| Active Comparator: Standard-CBT 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. |
Behavioral: Standard-CBT
Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
|
Outcome Measures
Primary Outcome Measures
- WHO Well-Being Index (WHO-5) [Week 19 after allocation]
Self-rating questionnaire, 5 items on positive quality of life, web-based
Secondary Outcome Measures
- Hopkins Symptom Check List (SCL-25) [Week 19 after allocation]
Validated questionnaire - web-based
- Work and Social Adjustment Scale (WSAS) [Week 19 after allocation]
Validated questionnaire - web-based
- Hamilton Depression Rating Scale (HDRS) [Week 19 after allocation]
6-item HDRS based on telephone interview
- Hamilton Anxiety Rating Scale (HARS) [Week 19 after allocation]
6-item HARS based on telephone interview
Other Outcome Measures
- Overall Anxiety Severity and Impairment Scale (OASIS) [Weekly, weeks 4-19 after allocation, before session]
Validated questionnaire
- Overall Depression Severity and Impairment Scale (ODSIS) [Weekly, weeks 4-19 after allocation, before session]
Validated questionnaire
- WHO Well-Being Index (WHO-5) [Weekly, weeks 4-19 after allocation, before session]
Validated questionnaire
- Positive Affect and Negative Affect Schedule (PANAS) [Week 19 after allocation]
Validated questionnaire - web-based
- Positive Affect and Negative Affect Schedule (PANAS) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Hopkins Symptom Check List (SCL-25) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Emotion Regulation Questionnaire (ERQ) [Week 19 after allocation]
Validated questionnaire - web-based
- Emotion Regulation Questionnaire (ERQ) [Week 42-43 after allocation]
Validated questionnaire - web-based
- WHO Well-Being Index (WHO-5) [Week 42-43 after allocation]
Self-rating questionnaire, 5 items on positive quality of life, web-based
- Emotion Regulation Strategies Questionnaire (ERSQ) [Week 19 after allocation]
Validated questionnaire - web-based
- Emotion Regulation Strategies Questionnaire (ERSQ) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Perseverative Thinking Questionnaire (PTQ) [Week 19 after allocation]
Validated questionnaire - web-based
- Perseverative Thinking Questionnaire (PTQ) [Week 42-43 after allocation]
Validated questionnaires - web-based
- Becks Depression inventory (BDI-II) [Week 19 after allocation]
Validated questionnaire - web-based
- Becks Depression inventory (BDI-II) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Work and Social Adjustment Scale (WSAS) [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 [Week 19 after allocation]
Validated questionnaire - web-based
- Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores [Week 42-43 after allocation]
Validated questionnaire - web-based
- Liebowitch Social Anxiety Scale (LSAS) [Week 19 after allocation]
Validated questionnaire - web-based
- Liebowitch Social Anxiety Scale (LSAS) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Panic Disorder Severity Scale (PDSS) [Week19 after allocation]
Validated questionnaire - web-based
- Panic Disorder Severity Scale (PDSS) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Mobility Inventory for Agoraphobia (MIA) [Week 19 after allocation]
Validated questionnaire - web-based
- Mobility Inventory for Agoraphobia (MIA) [Week 42-43 after allocation]
Validated questionnaire - web-based
- Hamilton Depression Rating Scale [Week 42-43 after allocation]
6-item HDRS based on telephone interview
- Hamilton Anxiety Rating Scale [Week 42-43 after allocation]
6-item HARS based on telephone interview
- Client Satisfaction Questionnaire [Week 43]
8-item validated questionnaire, web-based
- Patient Evaluation of Group Therapy [Week 19]
Purpose-made questionnaire
- Group Questionnaire - brief [Weekly, weeks 4-19 after allocation, after session]
8 items from validated questionnaire about group atmosphere
- Therapist Ratings of session methods and atmosphere [Weekly, weeks 4-19 after allocation, after session]
Purpose-made questionnaire
- Homework and Event Tracker [Weekly, weeks 4-19 after allocation, before session]
Purpose-made question for patients about homework and events previous week
Eligibility Criteria
Criteria
Inclusion Criteria:
Referred to Danish Mental Health Service
-
a principal DSM-5 diagnosis of Unipolar Depression (single episode or recurrent)(app. 50%), Social Anxiety Disorder (app. 25%), and Agoraphobia/Panic Disorder (app 25%)
-
the patient is currently not using any antidepressants or use accepted antidepressants (according to predefined list), which have been unchanged for at least 4 weeks before inclusion and no change in antidepressants is anticipated,
-
sufficient knowledge of the Danish language.
Exclusion Criteria:
-
risk of suicide is high according to clinicians or assessment researchers
-
alcohol or drug dependence,
-
cluster A or B (DSM-5) personality disorder diagnosed by intake clinicians or assessment researcher,
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co-morbidity of pervasive developmental disorder, psychotic disorders, eating disorders, bipolar disorder, or severe physical illness,
-
psychopharmacological treatment other than those predefined as acceptable,
-
patient does not accept to stop the use of anxiolytics within the first four weeks of intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Psychotherapeutic Unit, Mental Health Centre Copenhagen | Copenhagen | Capital Region | Denmark | 2200 |
| 2 | Outpatient Clinic for Anxiety and Personality Disorders | Risskov | Central Region | Denmark | 8240 |
| 3 | Outpatient Clinic for Mania and Depression | Risskov | Central Region | Denmark | 8240 |
| 4 | Psychiatric Outpatient Clinic | Slagelse | Region Zealand | Denmark | 4200 |
Sponsors and Collaborators
- Psychiatric Research Unit, Region Zealand, Denmark
- Aarhus University Hospital
- Mental Health Centre Copenhagen
- University of Copenhagen
Investigators
- Principal Investigator: Sidse MH Arnfred, MD,PhD,DMSc, Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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. Epub 2016 Oct 5.
- 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. Review.
- 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. Review.
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