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

Not Applicable

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Unified Cognitive-Behavioral Therapy; Behavioral: Combined Cognitive-Behavioral and Dance/Movement Therapy

• Registration Number: NCT02304796
• Lead Sponsor: Shalvata Mental Health Center

Brief Summary

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

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:

1. Both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living.

2. 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).

3. 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.

Study Timeline

• Study First Submitted: 2014-11-22
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Study Start: 2015-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified CBT	Unified Cognitive-Behavioral Therapy	Group psychotherapy according to the principles of the Cognitive-Behavioral Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011).
Combined CBT-DMT	Combined Cognitive-Behavioral and Dance/Movement Therapy	Group psychotherapy combining cognitive-behavioral principles and techniques with dance/movement therapy techniques.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel