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

NCT02304796 | Unknown

• 1 other identifier: 0015-14-SHA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Anxiety Disorders; Group Psychotherapy; Cognitive-Behavioral Therapy; Dance/Movement Therapy; CBT; DMT; Unified Protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Other Outcomes (4)

• Change in Difficulties in Emotion Regulation Scale

  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 Body Sensations 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)

• Change in Bodily Awareness of Emotions Subscale of the Emotion Awareness Questionnaire - Revised

  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)

Study Arms (2)

Unified CBT

EXPERIMENTAL

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

Combined CBT-DMT

EXPERIMENTAL

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

Behavioral: Combined Cognitive-Behavioral and Dance/Movement Therapy

Interventions

Unified Cognitive-Behavioral Therapy BEHAVIORAL

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.

Unified CBT

Combined Cognitive-Behavioral and Dance/Movement Therapy BEHAVIORAL

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.

Combined CBT-DMT

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Yuval Bloch, M.D.

  Shalvata Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

IL (1)