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

Primary Purpose

Depression, Unipolar, Anxiety Disorder Social, Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
UP-CBT
Standard-CBT
Sponsored by
Psychiatric Research Unit, Region Zealand, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Unipolar focused on measuring Cognitive Behavior Therapy, Negative Affect, Unified Protocol, Session Tracking, Mechanisms of Change in Psychotherapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psychotherapeutic Unit, Mental Health Centre Copenhagen
  • Outpatient Clinic for Anxiety and Personality Disorders
  • Outpatient Clinic for Mania and Depression
  • Psychiatric Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UP-CBT

Standard-CBT

Arm Description

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 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.

Outcomes

Primary Outcome Measures

WHO Well-Being Index (WHO-5)
Self-rating questionnaire, 5 items on positive quality of life, web-based

Secondary Outcome Measures

Hopkins Symptom Check List (SCL-25)
Validated questionnaire - web-based
Work and Social Adjustment Scale (WSAS)
Validated questionnaire - web-based
Hamilton Depression Rating Scale (HDRS)
6-item HDRS based on telephone interview
Hamilton Anxiety Rating Scale (HARS)
6-item HARS based on telephone interview

Full Information

First Posted
October 25, 2016
Last Updated
September 15, 2020
Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
Collaborators
Aarhus University Hospital, Mental Health Centre Copenhagen, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02954731
Brief Title
Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric Research Unit, Region Zealand, Denmark
Collaborators
Aarhus University Hospital, Mental Health Centre Copenhagen, University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Unipolar, Anxiety Disorder Social, Panic Disorder
Keywords
Cognitive Behavior Therapy, Negative Affect, Unified Protocol, Session Tracking, Mechanisms of Change in Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UP-CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard-CBT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UP-CBT
Intervention Description
Psychotherapy in groups based on the "Unified Protocol" a third generation CBT-type psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Standard-CBT
Intervention Description
Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
Primary Outcome Measure Information:
Title
WHO Well-Being Index (WHO-5)
Description
Self-rating questionnaire, 5 items on positive quality of life, web-based
Time Frame
Week 19 after allocation
Secondary Outcome Measure Information:
Title
Hopkins Symptom Check List (SCL-25)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Work and Social Adjustment Scale (WSAS)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Hamilton Depression Rating Scale (HDRS)
Description
6-item HDRS based on telephone interview
Time Frame
Week 19 after allocation
Title
Hamilton Anxiety Rating Scale (HARS)
Description
6-item HARS based on telephone interview
Time Frame
Week 19 after allocation
Other Pre-specified Outcome Measures:
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
Validated questionnaire
Time Frame
Weekly, weeks 4-19 after allocation, before session
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
Validated questionnaire
Time Frame
Weekly, weeks 4-19 after allocation, before session
Title
WHO Well-Being Index (WHO-5)
Description
Validated questionnaire
Time Frame
Weekly, weeks 4-19 after allocation, before session
Title
Positive Affect and Negative Affect Schedule (PANAS)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Positive Affect and Negative Affect Schedule (PANAS)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Hopkins Symptom Check List (SCL-25)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Emotion Regulation Questionnaire (ERQ)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Emotion Regulation Questionnaire (ERQ)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
WHO Well-Being Index (WHO-5)
Description
Self-rating questionnaire, 5 items on positive quality of life, web-based
Time Frame
Week 42-43 after allocation
Title
Emotion Regulation Strategies Questionnaire (ERSQ)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Emotion Regulation Strategies Questionnaire (ERSQ)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Perseverative Thinking Questionnaire (PTQ)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Perseverative Thinking Questionnaire (PTQ)
Description
Validated questionnaires - web-based
Time Frame
Week 42-43 after allocation
Title
Becks Depression inventory (BDI-II)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Becks Depression inventory (BDI-II)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Work and Social Adjustment Scale (WSAS)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Liebowitch Social Anxiety Scale (LSAS)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Liebowitch Social Anxiety Scale (LSAS)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Panic Disorder Severity Scale (PDSS)
Description
Validated questionnaire - web-based
Time Frame
Week19 after allocation
Title
Panic Disorder Severity Scale (PDSS)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Mobility Inventory for Agoraphobia (MIA)
Description
Validated questionnaire - web-based
Time Frame
Week 19 after allocation
Title
Mobility Inventory for Agoraphobia (MIA)
Description
Validated questionnaire - web-based
Time Frame
Week 42-43 after allocation
Title
Hamilton Depression Rating Scale
Description
6-item HDRS based on telephone interview
Time Frame
Week 42-43 after allocation
Title
Hamilton Anxiety Rating Scale
Description
6-item HARS based on telephone interview
Time Frame
Week 42-43 after allocation
Title
Client Satisfaction Questionnaire
Description
8-item validated questionnaire, web-based
Time Frame
Week 43
Title
Patient Evaluation of Group Therapy
Description
Purpose-made questionnaire
Time Frame
Week 19
Title
Group Questionnaire - brief
Description
8 items from validated questionnaire about group atmosphere
Time Frame
Weekly, weeks 4-19 after allocation, after session
Title
Therapist Ratings of session methods and atmosphere
Description
Purpose-made questionnaire
Time Frame
Weekly, weeks 4-19 after allocation, after session
Title
Homework and Event Tracker
Description
Purpose-made question for patients about homework and events previous week
Time Frame
Weekly, weeks 4-19 after allocation, before session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Referred to Danish Mental Health Service 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%) 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, sufficient knowledge of the Danish language. Exclusion Criteria: risk of suicide is high according to clinicians or assessment researchers alcohol or drug dependence, cluster A or B (DSM-5) personality disorder diagnosed by intake clinicians or assessment researcher, co-morbidity of pervasive developmental disorder, psychotic disorders, eating disorders, bipolar disorder, or severe physical illness, psychopharmacological treatment other than those predefined as acceptable, patient does not accept to stop the use of anxiolytics within the first four weeks of intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidse MH Arnfred, MD,PhD,DMSc
Organizational Affiliation
Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychotherapeutic Unit, Mental Health Centre Copenhagen
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Outpatient Clinic for Anxiety and Personality Disorders
City
Risskov
State/Province
Central Region
ZIP/Postal Code
8240
Country
Denmark
Facility Name
Outpatient Clinic for Mania and Depression
City
Risskov
State/Province
Central Region
ZIP/Postal Code
8240
Country
Denmark
Facility Name
Psychiatric Outpatient Clinic
City
Slagelse
State/Province
Region Zealand
ZIP/Postal Code
4200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
27705086
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. doi: 10.1080/16506073.2016.1227360. Epub 2016 Oct 5.
Results Reference
background
PubMed Identifier
24646219
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.
Results Reference
background
PubMed Identifier
22697453
Citation
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.
Results Reference
background
PubMed Identifier
20886609
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.
Results Reference
background
PubMed Identifier
28114915
Citation
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.
Results Reference
derived

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

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