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

Primary Purpose

Anxiety Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Unified Cognitive-Behavioral Therapy
Combined Cognitive-Behavioral and Dance/Movement Therapy
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety Disorders, Group Psychotherapy, Cognitive-Behavioral Therapy, Dance/Movement Therapy, CBT, DMT, Unified Protocol

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Shalvata Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unified CBT

Combined CBT-DMT

Arm Description

Group psychotherapy according to the principles of the Cognitive-Behavioral Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011).

Group psychotherapy combining cognitive-behavioral principles and techniques with dance/movement therapy techniques.

Outcomes

Primary Outcome Measures

Change in Hamilton Anxiety Rating Scale
Structured independent evaluator interview for assessing severity of anxiety

Secondary Outcome Measures

Change in Depression, Anxiety, Stress Scales-21
Self-report measure of depression, anxiety and stress
Change in Valued Living Questionnaire
Self-report measure of valued living
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

Full Information

First Posted
November 22, 2014
Last Updated
April 13, 2016
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02304796
Brief Title
Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety Disorders, Group Psychotherapy, Cognitive-Behavioral Therapy, Dance/Movement Therapy, CBT, DMT, Unified Protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unified CBT
Arm Type
Experimental
Arm Description
Group psychotherapy according to the principles of the Cognitive-Behavioral Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011).
Arm Title
Combined CBT-DMT
Arm Type
Experimental
Arm Description
Group psychotherapy combining cognitive-behavioral principles and techniques with dance/movement therapy techniques.
Intervention Type
Behavioral
Intervention Name(s)
Unified Cognitive-Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Combined Cognitive-Behavioral and Dance/Movement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hamilton Anxiety Rating Scale
Description
Structured independent evaluator interview for assessing severity of anxiety
Time Frame
Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Secondary Outcome Measure Information:
Title
Change in Depression, Anxiety, Stress Scales-21
Description
Self-report measure of depression, anxiety and stress
Time Frame
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)
Title
Change in Valued Living Questionnaire
Description
Self-report measure of valued living
Time Frame
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)
Title
Change in Mini International Neuropsychiatric Interview
Description
Structured independent evaluator interview for assessing Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR) axis I diagnoses
Time Frame
Intake (entry to study), Pre-treatment (1 month from intake), Post-Treatment (6 months from intake), Follow-Up (7 months from intake)
Other Pre-specified Outcome Measures:
Title
Change in Difficulties in Emotion Regulation Scale
Description
Self-report measure of different aspects of emotion regulation difficulties
Time Frame
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)
Title
Change in Body Sensations Questionnaire
Description
Self-report measure of fear of bodily sensations
Time Frame
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)
Title
Change in Bodily Awareness of Emotions Subscale of the Emotion Awareness Questionnaire - Revised
Description
Self-report measure of awareness of bodily sensations/movement and their emotional meaning
Time Frame
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)
Title
Change in Working Alliance Inventory - Short and Revised form - Group version
Description
Self-report measure of working alliance in group therapy
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, M.D.
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders

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