Clinical trial NCT02954731: Trans-diagnostic Group CBT vs. Standard Group CBT for Depression, Social Anxiety and Agoraphobia/Panic Disorder
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Anxiety Disorder Social
Panic Disorder
Keywords: Cognitive Behavior Therapy
Negative Affect
Unified Protocol
Session Tracking
Mechanisms of Change in Psychotherapy
Lead sponsor: Psychiatric Research Unit, Region Zealand, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Mental Health Services in the Capital Region, Denmark
name: University of Copenhagen
First posted: 2016-11-03
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: WHO Well-Being Index (WHO-5)
timeFrame: Week 19 after allocation
Secondary outcomes:
measure: Hopkins Symptom Check List (SCL-25)
timeFrame: Week 19 after allocation
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Week 19 after allocation
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: Week 19 after allocation
measure: Hamilton Anxiety Rating Scale (HARS)
timeFrame: Week 19 after allocation
Other outcomes:
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Weekly, weeks 4-19 after allocation, before session
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Weekly, weeks 4-19 after allocation, before session
measure: WHO Well-Being Index (WHO-5)
timeFrame: Weekly, weeks 4-19 after allocation, before session
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: Week 19 after allocation
measure: Positive Affect and Negative Affect Schedule (PANAS)
timeFrame: Week 42-43 after allocation
measure: Hopkins Symptom Check List (SCL-25)
timeFrame: Week 42-43 after allocation
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Week 19 after allocation
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Week 42-43 after allocation
measure: WHO Well-Being Index (WHO-5)
timeFrame: Week 42-43 after allocation
measure: Emotion Regulation Strategies Questionnaire (ERSQ)
timeFrame: Week 19 after allocation
measure: Emotion Regulation Strategies Questionnaire (ERSQ)
timeFrame: Week 42-43 after allocation
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Week 19 after allocation
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: Week 42-43 after allocation
measure: Becks Depression inventory (BDI-II)
timeFrame: Week 19 after allocation
measure: Becks Depression inventory (BDI-II)
timeFrame: Week 42-43 after allocation
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Week 42-43 after allocation
measure: Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
timeFrame: Week 19 after allocation
measure: Personality Inventory for DSM-5 - Short Form (PID-5 SF) Negative Affectivity and Detachment domain scores
timeFrame: Week 42-43 after allocation
measure: Liebowitch Social Anxiety Scale (LSAS)
timeFrame: Week 19 after allocation
measure: Liebowitch Social Anxiety Scale (LSAS)
timeFrame: Week 42-43 after allocation
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Week19 after allocation
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Week 42-43 after allocation
measure: Mobility Inventory for Agoraphobia (MIA)
timeFrame: Week 19 after allocation
measure: Mobility Inventory for Agoraphobia (MIA)
timeFrame: Week 42-43 after allocation
measure: Hamilton Depression Rating Scale
timeFrame: Week 42-43 after allocation
measure: Hamilton Anxiety Rating Scale
timeFrame: Week 42-43 after allocation
measure: Client Satisfaction Questionnaire
timeFrame: Week 43
measure: Patient Evaluation of Group Therapy
timeFrame: Week 19
measure: Group Questionnaire - brief
timeFrame: Weekly, weeks 4-19 after allocation, after session
measure: Therapist Ratings of session methods and atmosphere
timeFrame: Weekly, weeks 4-19 after allocation, after session
measure: Homework and Event Tracker
timeFrame: Weekly, weeks 4-19 after allocation, before session
Locations:
city: Copenhagen
country: Denmark
facility: Psychotherapeutic Unit, Mental Health Centre Copenhagen
state: Capital Region
city: Risskov
country: Denmark
facility: Outpatient Clinic for Anxiety and Personality Disorders
state: Central Region
city: Risskov
country: Denmark
facility: Outpatient Clinic for Mania and Depression
state: Central Region
city: Slagelse
country: Denmark
facility: Psychiatric Outpatient Clinic
state: Region Zealand
Study officials:
affiliation: Universityhospital Copenhagen, Psychiatry West, Mental Health Services Region Zealand
name: Sidse MH Arnfred, MD,PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.