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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02368444
Other study ID # ITRP-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date January 2016

Study information

Verified date June 2022
Source Georgetown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Yoga Studio Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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