A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy and Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Cognitive Behavioral Therapy and Yoga | Behavioral: Cognitive Behavioral Therapy and Yoga<br>* Group Cognitive Behavioral Therapy Treatment and Yoga Program<br>* Other names: Kundalini Yoga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Baseline and 8 weeks and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) | Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) | Baseline and 8 weeks and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress, Sleep