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

NCT ID: NCT02954731

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-12-11

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.

Conditions

Depression, Unipolar; Anxiety Disorder Social; Panic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

UP-CBT

Intervention Type: BEHAVIORAL

Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy

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.

Group Type: ACTIVE_COMPARATOR

Standard-CBT

Intervention Type: BEHAVIORAL

Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy

Interventions

UP-CBT

Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy

Intervention Type: BEHAVIORAL

Standard-CBT

Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Psychiatric Research Unit, Region Zealand, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Sidse Arnfred

Associate Professor, Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidse MH Arnfred, MD,PhD,DMSc

Role: PRINCIPAL_INVESTIGATOR

Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand

Locations

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 Sjælland, Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 27705086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24646219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22697453 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20886609 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37106559 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28114915 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SA005

Identifier Type: -

Identifier Source: org_study_id