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

Not Applicable

Completed

• Conditions: Depression, Unipolar; Anxiety Disorder Social; Panic Disorder
• Interventions: Behavioral: Standard-CBT; Behavioral: UP-CBT

• Registration Number: NCT02954731
• Lead Sponsor: Psychiatric Research Unit, Region Zealand, Denmark

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.

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 Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2016-12
• Primary Completion: 2019-04-11
• Study Completion: 2019-12-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-CBT	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.
UP-CBT	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Hamilton Anxiety Rating Scale (HARS)	Week 19 after allocation	6-item HARS based on telephone interview
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

Trial Locations

Locations (4)

Psychiatric Outpatient Clinic; 🇩🇰 Slagelse, Region Zealand, 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