Back to resultsA Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy and Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Posttraumatic Stress, Sleep
Eligibility Criteria
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
Sites / Locations
- Yoga Studio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
Cognitive Behavioral Therapy and Yoga
Outcomes
Primary Outcome 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)
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 Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02368444
Brief Title
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Official Title
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Posttraumatic Stress, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy and Yoga
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy and Yoga
Other Intervention Name(s)
T.E.A.M. Cognitive Behavioral Therapy, Kundalini Yoga
Intervention Description
Group Cognitive Behavioral Therapy Treatment and Yoga Program
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)
Description
Changes in Sleep Quality will be measured using the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline and 8 weeks and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie K Staples, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yoga Studio
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Cognitive Behavioral Therapy and Yoga Program for Trauma Symptoms
We'll reach out to this number within 24 hrs