A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

Overview

The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Detailed Description

The purpose of the proposed study is to evaluate the effectiveness of a cognitive behavioral therapy (CBT) and yoga program for improving posttraumatic stress disorder (PTSD) symptoms and sleep quality in people who have experienced a traumatic event and are reporting trauma symptoms. The total length of the program will be 8 weeks. The sessions will be held 3 hours per week with 1.5 hours of group cognitive behavioral therapy and 1.5 hours of yoga. Changes in PTSD symptoms and sleep quality will be measured at baseline, immediately following the program, and at 2 month follow-up.

Interventions

  • Behavioral: Cognitive Behavioral Therapy and Yoga
    • Group Cognitive Behavioral Therapy Treatment and Yoga Program

Arms, Groups and Cohorts

  • Experimental: Intervention Group
    • Cognitive Behavioral Therapy and Yoga

Clinical Trial Outcome Measures

Primary Measures

  • Changes in Posttraumatic Stress Symptoms will be measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (PCL-5)
    • Time Frame: Baseline and 8 weeks and 16 weeks
    • Changes in Posttraumatic Stress Symptoms will be measured using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (PCL-5)

Secondary Measures

  • Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)
    • Time Frame: Baseline and 8 weeks and 16 weeks
    • Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)

Participating in This Clinical Trial

Inclusion Criteria

  • clinically diagnosed posttraumatic stress disorder (PTSD) or subthreshold PTSD symptoms Exclusion Criteria:

  • current uncontrolled psychotic or bipolar disorder, significant cognitive impairment, substance dependence, non-English speaking, or a significant medical condition that would interfere with participation in the yoga portion of the program

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Georgetown University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julie Staples, PhD, Assistant Adjunct Professor – Georgetown University
  • Overall Official(s)
    • Julie K Staples, Ph.D., Principal Investigator, Georgetown University

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