Anxiety Disorder Social, Depression, Unipolar, Panic Disorder
Conditions
Keywords
Cognitive Behavior Therapy, Negative Affect, Unified Protocol, Session Tracking, Mechanisms of Change in Psychotherapy
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.
Interventions
BEHAVIORALUP-CBT
Psychotherapy in groups based on the Unified Protocol a third generation CBT-type psychotherapy
BEHAVIORALStandard-CBT
Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
Sponsors
Aarhus University Hospital
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Psychiatric Research Unit, Region Zealand, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHO Well-Being Index (WHO-5) | Week 19 after allocation | Self-rating questionnaire, 5 items on positive quality of life, web-based |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Hamilton Anxiety Rating Scale (HARS) | Week 19 after allocation | 6-item HARS based on telephone interview |
Other
| Measure | Time frame | Description |
|---|---|---|
| Emotion Regulation Questionnaire (ERQ) | Week 19 after allocation | Validated questionnaire - web-based |
| Emotion Regulation Strategies Questionnaire (ERSQ) | Week 19 after allocation | Validated questionnaire - web-based |
| Perseverative Thinking Questionnaire (PTQ) | Week 19 after allocation | Validated questionnaire - web-based |
| Becks Depression inventory (BDI-II) | Week 19 after allocation | Validated questionnaire - web-based |
| Work and Social Adjustment Scale (WSAS) | 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 | Week 19 after allocation | Validated questionnaire - web-based |
| Liebowitch Social Anxiety Scale (LSAS) | Week 19 after allocation | Validated questionnaire - web-based |
| Panic Disorder Severity Scale (PDSS) | Week19 after allocation | Validated questionnaire - web-based |
| Overall Anxiety Severity and Impairment Scale (OASIS) | Weekly, weeks 4-19 after allocation, before session | Validated questionnaire |
| Hamilton Depression Rating Scale | Week 42-43 after allocation | 6-item HDRS based on telephone interview |
| Hamilton Anxiety Rating Scale | Week 42-43 after allocation | 6-item HARS based on telephone interview |
| Client Satisfaction Questionnaire | Week 43 | 8-item validated questionnaire, web-based |
| Patient Evaluation of Group Therapy | Week 19 | Purpose-made questionnaire |
| Group Questionnaire - brief | Weekly, weeks 4-19 after allocation, after session | 8 items from validated questionnaire about group atmosphere |
| Therapist Ratings of session methods and atmosphere | Weekly, weeks 4-19 after allocation, after session | Purpose-made questionnaire |
| Homework and Event Tracker | Weekly, weeks 4-19 after allocation, before session | Purpose-made question for patients about homework and events previous week |
| Mobility Inventory for Agoraphobia (MIA) | Week 19 after allocation | Validated questionnaire - web-based |
| Overall Depression Severity and Impairment Scale (ODSIS) | Weekly, weeks 4-19 after allocation, before session | Validated questionnaire |
| WHO Well-Being Index (WHO-5) | Weekly, weeks 4-19 after allocation, before session | Validated questionnaire |
| Positive Affect and Negative Affect Schedule (PANAS) | Week 19 after allocation | Validated questionnaire - web-based |
| Hopkins Symptom Check List (SCL-25) | Week 42-43 after allocation | Validated questionnaire - web-based |
Countries
Denmark
Outcome results
None listed