Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder

Panic Disorder Clinical Trial

— TRACT-RCT  

Official title:

Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder: A Pragmatic, Multicenter Non-inferiority Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02954731
• Other study ID #: SA005
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 11, 2019

Study information

• Verified date: September 2020
• Source: Psychiatric Research Unit, Region Zealand, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: December 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

Referred to Danish Mental Health Service

1. 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%)

2. 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,

3. sufficient knowledge of the Danish language.

Exclusion Criteria:

1. risk of suicide is high according to clinicians or assessment researchers

2. alcohol or drug dependence,

3. cluster A or B (DSM-5) personality disorder diagnosed by intake clinicians or assessment researcher,

4. co-morbidity of pervasive developmental disorder, psychotic disorders, eating disorders, bipolar disorder, or severe physical illness,

5. psychopharmacological treatment other than those predefined as acceptable,

6. patient does not accept to stop the use of anxiolytics within the first four weeks of intervention.

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorder Social
• Anxiety Disorders
• Depression
• Depression, Unipolar
• Depressive Disorder
• Disease
• Panic Disorder
• Phobia, Social

Intervention

Behavioral:
• UP-CBT
Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy
• Standard-CBT
Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy

Locations

Country	Name	City	State
Denmark	Psychotherapeutic Unit, Mental Health Centre Copenhagen	Copenhagen	Capital Region
Denmark	Outpatient Clinic for Anxiety and Personality Disorders	Risskov	Central Region
Denmark	Outpatient Clinic for Mania and Depression	Risskov	Central Region
Denmark	Psychiatric Outpatient Clinic	Slagelse	Region Zealand

Sponsors (4)

Lead Sponsor	Collaborator
Psychiatric Research Unit, Region Zealand, Denmark	Aarhus University Hospital, Mental Health Centre Copenhagen, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Anxiety Severity and Impairment Scale (OASIS)	Validated questionnaire	Weekly, weeks 4-19 after allocation, before session
Other	Overall Depression Severity and Impairment Scale (ODSIS)	Validated questionnaire	Weekly, weeks 4-19 after allocation, before session
Other	WHO Well-Being Index (WHO-5)	Validated questionnaire	Weekly, weeks 4-19 after allocation, before session
Other	Positive Affect and Negative Affect Schedule (PANAS)	Validated questionnaire - web-based	Week 19 after allocation
Other	Positive Affect and Negative Affect Schedule (PANAS)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Hopkins Symptom Check List (SCL-25)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Emotion Regulation Questionnaire (ERQ)	Validated questionnaire - web-based	Week 19 after allocation
Other	Emotion Regulation Questionnaire (ERQ)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	WHO Well-Being Index (WHO-5)	Self-rating questionnaire, 5 items on positive quality of life, web-based	Week 42-43 after allocation
Other	Emotion Regulation Strategies Questionnaire (ERSQ)	Validated questionnaire - web-based	Week 19 after allocation
Other	Emotion Regulation Strategies Questionnaire (ERSQ)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Perseverative Thinking Questionnaire (PTQ)	Validated questionnaire - web-based	Week 19 after allocation
Other	Perseverative Thinking Questionnaire (PTQ)	Validated questionnaires - web-based	Week 42-43 after allocation
Other	Becks Depression inventory (BDI-II)	Validated questionnaire - web-based	Week 19 after allocation
Other	Becks Depression inventory (BDI-II)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Work and Social Adjustment Scale (WSAS)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores	Validated questionnaire - web-based	Week 19 after allocation
Other	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
Other	Liebowitch Social Anxiety Scale (LSAS)	Validated questionnaire - web-based	Week 19 after allocation
Other	Liebowitch Social Anxiety Scale (LSAS)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Panic Disorder Severity Scale (PDSS)	Validated questionnaire - web-based	Week19 after allocation
Other	Panic Disorder Severity Scale (PDSS)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Mobility Inventory for Agoraphobia (MIA)	Validated questionnaire - web-based	Week 19 after allocation
Other	Mobility Inventory for Agoraphobia (MIA)	Validated questionnaire - web-based	Week 42-43 after allocation
Other	Hamilton Depression Rating Scale	6-item HDRS based on telephone interview	Week 42-43 after allocation
Other	Hamilton Anxiety Rating Scale	6-item HARS based on telephone interview	Week 42-43 after allocation
Other	Client Satisfaction Questionnaire	8-item validated questionnaire, web-based	Week 43
Other	Patient Evaluation of Group Therapy	Purpose-made questionnaire	Week 19
Other	Group Questionnaire - brief	8 items from validated questionnaire about group atmosphere	Weekly, weeks 4-19 after allocation, after session
Other	Therapist Ratings of session methods and atmosphere	Purpose-made questionnaire	Weekly, weeks 4-19 after allocation, after session
Other	Homework and Event Tracker	Purpose-made question for patients about homework and events previous week	Weekly, weeks 4-19 after allocation, before session
Primary	WHO Well-Being Index (WHO-5)	Self-rating questionnaire, 5 items on positive quality of life, web-based	Week 19 after allocation
Secondary	Hopkins Symptom Check List (SCL-25)	Validated questionnaire - web-based	Week 19 after allocation
Secondary	Work and Social Adjustment Scale (WSAS)	Validated questionnaire - web-based	Week 19 after allocation
Secondary	Hamilton Depression Rating Scale (HDRS)	6-item HDRS based on telephone interview	Week 19 after allocation
Secondary	Hamilton Anxiety Rating Scale (HARS)	6-item HARS based on telephone interview	Week 19 after allocation