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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02304796
• Other study ID #: 0015-14-SHA
• Status: Active, not recruiting
• Phase: N/A
• First received: November 22, 2014
• Last updated: April 13, 2016
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Unified Cognitive-Behavioral Therapy
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.
• Combined Cognitive-Behavioral and Dance/Movement Therapy
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.

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. New York: Oxford University Press: 2011.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Difficulties in Emotion Regulation Scale	Self-report measure of different aspects of emotion regulation difficulties	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)	No
Other	Change in Body Sensations Questionnaire	Self-report measure of fear of bodily sensations	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)	No
Other	Change in Bodily Awareness of Emotions Subscale of the Emotion Awareness Questionnaire - Revised	Self-report measure of awareness of bodily sensations/movement and their emotional meaning	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)	No
Other	Change in Working Alliance Inventory - Short and Revised form - Group version	Self-report measure of working alliance in group therapy	Intake (entry to study), Pre-treatment (1 month from intake), Session 5 (2 months from intake), Mid-Treatment (3.5 months from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No