- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368444
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
June 5, 2022 updated by: Julie Staples, PhD, Georgetown University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87114
- Yoga Studio
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Cognitive Behavioral Therapy and Yoga
|
Group Cognitive Behavioral Therapy Treatment and Yoga Program
Other Names:
|
What is the study measuring?
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)
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)
|
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)
Time Frame: Baseline and 8 weeks and 16 weeks
|
Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)
|
Baseline and 8 weeks and 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie K Staples, Ph.D., Georgetown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
February 10, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Actual)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 5, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITRP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Disorders, Post-Traumatic
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
US Department of Veterans AffairsEmory UniversityWithdrawnPost-Traumatic Stress Disorders
-
University of KonstanzGerman Research Foundation; NGO vivo e.V.; GTZ-German Technical Cooperation,... and other collaboratorsCompletedPost-Traumatic Stress DisordersSri Lanka
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruitingPost-traumatic Stress DisorderFrance
-
VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesRecruitingPost-Traumatic Stress DisorderUnited States
-
Johns Hopkins UniversityWithdrawnPost-Traumatic Stress Disorder
Clinical Trials on Cognitive Behavioral Therapy and Yoga
-
University of PittsburghCompletedSmoking CessationUnited States
-
Children's Hospital of PhiladelphiaActive, not recruitingPediatric Chronic PainUnited States
-
Wake Forest University Health SciencesPatient-Centered Outcomes Research InstituteCompleted
-
Imad Najm MDRecruiting
-
Yale UniversityCrohn's & Colitis Foundation of America (CCFA)Recruiting
-
NYU Langone HealthNational Center for Complementary and Integrative Health (NCCIH)Completed
-
The Miriam HospitalNational Institutes of Health (NIH); National Center for Complementary and...Completed
-
The Miriam HospitalNational Center for Complementary and Integrative Health (NCCIH)Unknown
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States