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Clinical Trials/NCT02304796
NCT02304796
Unknown
N/A

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

Shalvata Mental Health Center1 site in 1 country24 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Shalvata Mental Health Center
Enrollment
24
Locations
1
Primary Endpoint
Change in Hamilton Anxiety Rating Scale
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
September 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Change in Hamilton Anxiety Rating Scale

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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