We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02954731
First Posted: November 3, 2016
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aarhus University Hospital
Mental Health Centre Copenhagen
University of Copenhagen
Information provided by (Responsible Party):
Sidse Arnfred, Psychiatric Research Unit, Region Zealand, Denmark
  Purpose

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.


Condition Intervention
Depression, Unipolar Anxiety Disorder Social Panic Disorder Behavioral: UP-CBT Behavioral: Standard-CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sidse Arnfred, Psychiatric Research Unit, Region Zealand, Denmark:

Primary Outcome Measures:
  • WHO Well-Being Index (WHO-5) [ Time Frame: Week 16-17 after allocation ]
    Self-rating questionnaire, 5 items on positive quality of life, web-based


Secondary Outcome Measures:
  • WHO Well-Being Index (WHO-5) [ Time Frame: Week 42-43 after allocation ]
    Self-rating questionnaire, 5 items on positive quality of life, web-based

  • Positive Affect and Negative Affect Schedule (PANAS) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - webbased

  • Positive Affect and Negative Affect Schedule (PANAS) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - webbased

  • Hopkins Symptom Check List (SCL-25) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - webbased

  • Hopkins Symptom Check List (SCL-25) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - webbased

  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Emotion Regulation Questionnaire (ERQ) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Emotion Regulation Strategies Questionnaire (ERSQ) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Emotion Regulation Strategies Questionnaire (ERSQ) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Perserverative Thinking Questionnaire (PTQ) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Perserverative Thinking Questionnaire (PTQ) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaires - web-based

  • Becks Depression inventory (BDI-II) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Becks Depression inventory (BDI-II) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Work and Social Adjustment Scale (WSAS) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Work and Social Adjustment Scale (WSAS) [ Time Frame: 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 [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Liebowitch Social Anxiety Scale (LSAS) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Liebowitch Social Anxiety Scale (LSAS) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Week16-17 after allocation ]
    Validated questionnaire - web-based

  • Panic Disorder Severity Scale (PDSS) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Mobility Inventory for Agoraphobia (MIA) [ Time Frame: Week 16-17 after allocation ]
    Validated questionnaire - web-based

  • Mobility Inventory for Agoraphobia (MIA) [ Time Frame: Week 42-43 after allocation ]
    Validated questionnaire - web-based

  • Hamilton Depression Rating Scale [ Time Frame: Week 16-17 after allocation ]
    6-item HDRS based on telephone interview

  • Hamilton Depression Rating Scale [ Time Frame: Week 42-43 after allocation ]
    6-item HDRS based on telephone interview

  • Hamilton Anxiety Rating Scale [ Time Frame: Week 16-17 after allocation ]
    6-item HARS based on telephone interview

  • Hamilton Anxiety Rating Scale [ Time Frame: Week 42-43 after allocation ]
    6-item HARS based on telephone interview

  • Client Satisfaction Questionnaire (CSQ) [ Time Frame: Week 16-17 after allocation ]
    Validated user satisfaction questionnaire

  • Group Therapy drop-out [ Time Frame: Week 16-17 after allocation ]
    Therapist declaration of patient drop-out

  • Service Adherence [ Time Frame: Week 1-16 after allocation, during intervention ]
    Patient self-ratings of attendance

  • Service Adherence Registration [ Time Frame: Weekly, weeks 3-17 after allocation ]
    Therapist registration of attendance


Other Outcome Measures:
  • Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Weekly, weeks 1-17 after allocation ]
    Validated questionnaire

  • Overall Depression Severity and Impairment Scale (ODSIS) [ Time Frame: Weekly, weeks 1-17 after allocation ]
    Validated questionnaire

  • WHO Well-Being Index (WHO-5) [ Time Frame: Weekly, weeks 1-17 after allocation ]
    Validated questionnaire


Estimated Enrollment: 248
Study Start Date: December 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Procol" 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

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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954731


Locations
Denmark
Psychotherapeutic Unit, Mental Health Centre Copenhagen
Copenhagen, Capital Region, Denmark, 2200
Outpatient Clinic for Anxiety and Personality Disorders
Risskov, Central Region, Denmark, 8240
Outpatient Clinic for Mania and Depression
Risskov, Central Region, Denmark, 8240
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidse Arnfred, Associate Professor, Consultant, Psychiatric Research Unit, Region Zealand, Denmark
ClinicalTrials.gov Identifier: NCT02954731     History of Changes
Other Study ID Numbers: SA005
First Submitted: October 25, 2016
First Posted: November 3, 2016
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Sidse Arnfred, Psychiatric Research Unit, Region Zealand, Denmark:
Cognitive Behavior Therapy
Negative Affect
Unified Protocol
Session Tracking
Mechanisms of Change in Psychotherapy

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Anxiety Disorders
Panic Disorder
Agoraphobia
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders


To Top