Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders

Study Overview
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Brief Summary
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The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy. In addition, change in proposed mechanism in each therapy will be examined, along with their association with change in outcome measures during therapy.

Detailed Description
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The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy. 24 patients will be randomized to 1 of the two treatment arms and treated with 20 weekly 1.5-2 hours therapy sessions. Independent evaluator and self-reports measures will be collected at intake, pre-treatment, session by session, post-treatment and and follow-up. Hypotheses: Both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living. Changes in process measures (proposed mechanism of change - emotion regulation, working alliance, fear of bodily sensations, bodily/movement awareness) will be predictive of change in outcome measures (anxiety severity and valued living). Changes in bodily/movement awareness will be more predictive of change in outcome measures in the CBT-DMT group than in the unified protocol group.

Official Title
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Randomized Controlled Trial Examining the Effectiveness of Two Group Psychotherapies for Anxiety Disorders: Unified Cognitive-behavioral Therapy vs. Combined Cognitive Behavioral and Dance/Movement Therapy

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Unified Cognitive-Behavioral Therapy
* Behavioral: Combined Cognitive-Behavioral and Dance/Movement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One of the following primary axis I DSM-IV-TR diagnoses: Panic disorder with or without Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Anxiety Disorder Not Otherwise Specified; Adjustment Disorder With Anxiety; Adjustment Disorder With Mixed Anxiety and Depressed Mood If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase of the study (5-6 months) Provision of written informed consent Exclusion Criteria: Current or past schizophrenia, psychosis, or bipolar disorder. Current suicidal ideation. Current substance/alcohol dependence or abuse. Cluster A or B personality disorder. Pregnancy (for women).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unified CBT<br>Group psychotherapy according to the principles of the Cognitive-Behavioral Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011). | Behavioral: Unified Cognitive-Behavioral Therapy<br>* 20 weekly sessions (1.5-2 hours each), based on the principles of the Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011) adapted for a group format. The treatment will include 8 different modules of varying length: motivation enhancement, understanding emotions, identifying and monitoring emotions, emotional awareness training, cognitive appraisal and reappraisal, emotional avoidance, emotion driven behaviors, awareness and tolerance of bodily sensations, relapse prevention.<br>|
| Experimental: Combined CBT-DMT<br>Group psychotherapy combining cognitive-behavioral principles and techniques with dance/movement therapy techniques. | Behavioral: Combined Cognitive-Behavioral and Dance/Movement Therapy<br>* 20 weekly sessions (1.5-2 hours each), based on combined cognitive-behavioral techniques (psychoeducation, awareness and tolerance of emotions, interoceptive exposures, in-vivo exposures, cognitive flexibility) and dance/movement techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Anxiety Rating Scale | Structured independent evaluator interview for assessing severity of anxiety | Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression, Anxiety, Stress Scales-21 | Self-report measure of depression, anxiety and stress | Intake (entry to study), Weekly during treatment (weekly between 1-6 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake) | 
| Change in Valued Living Questionnaire | Self-report measure of valued living | Intake (entry to study), Pre-treatment (1 month from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake) | 
| Change in Mini International Neuropsychiatric Interview | Structured independent evaluator interview for assessing Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR) axis I diagnoses | Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Disorders, Group Psychotherapy, Cognitive-Behavioral Therapy, Dance/Movement Therapy, CBT, DMT, Unified Protocol