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

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

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder; Depression, Unipolar; Anxiety Disorder Social
• Intervention / Treatment: Behavioral: UP-CBT; Behavioral: Standard-CBT

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 Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2200
      • Psychotherapeutic Unit, Mental Health Centre Copenhagen
  • Central Region
    • Risskov, Central Region, Denmark, 8240
      • Outpatient Clinic for Anxiety and Personality Disorders
    • Risskov, Central Region, Denmark, 8240
      • Outpatient Clinic for Mania and Depression
  • Region Zealand
    • Slagelse, Region Zealand, Denmark, 4200
      • Psychiatric Outpatient Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Psychiatric Research Unit, Region Zealand, Denmark
• Collaborators: Aarhus University Hospital; University of Copenhagen; Mental Health Centre Copenhagen
• Investigators: Principal Investigator: Sidse MH Arnfred, MD,PhD,DMSc, Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ACTUAL): April 11, 2019
• Study Completion (ACTUAL): December 11, 2019

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (ESTIMATE): November 3, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Negative Affect; Unified Protocol; Cognitive Behavior Therapy; Session Tracking; Mechanisms of Change in Psychotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Phobic Disorders; Depression; Depressive Disorder; Disease; Anxiety Disorders; Phobia, Social; Panic Disorder; Agoraphobia
• Other Study ID Numbers: SA005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.