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Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)

Primary Purpose

Post-Traumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yoga treatment

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring post traumatic stress disorder, yoga, meditation, military, veteran, trauma, stress, depression, anxiety, insomnia, autonomic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female military veterans and active duty military personnel aged 18 and older
A DSM IV diagnosis of post-traumatic stress disorder
Potential subjects on medications are eligible to participate in the study
Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process

Exclusion Criteria:

Potential subjects are ineligible if pregnant and in their third trimester.
Potential subjects are ineligible if they are confined to a wheel chair.

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga treatment

Waitlist

Arm Description

Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period. This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

PTSD Checklist Military Version (PCL-M)

Impact of Events Scale - Revised (IES-R)

25-item Resilience Scale (RS)

Twenty-four-hour urinary samples

10-minute segment of a seated 30-minute electrocardiogram recording session

Beck Depression Inventory (BDI)

Spielberger State Trait Anxiety Inventory (STAI)

Daily Sleep Wake Diaries

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

Credibility Expectancy Questionnaire (CEQ)

Body-Oriented State Questionnaire (BOSC)

5-Facet Mindfulness Questionnaire (FFMQ)

Perceived Stress Scale (PSS)

Yoga Follow-up Questionnaire

PTSD Checklist Civilian Version (PCL-C)

Full Information

NCT ID

NCT00962403

First Posted

August 13, 2009

Last Updated

March 19, 2013

Sponsor

Brigham and Women's Hospital

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT00962403

Brief Title

Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Acronym

EYIPTSD

Official Title

Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group. Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.

Detailed Description

Specific Aims: To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group. To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment. To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved. To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

Keywords

post traumatic stress disorder, yoga, meditation, military, veteran, trauma, stress, depression, anxiety, insomnia, autonomic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yoga treatment

Arm Type

Experimental

Arm Title

Waitlist

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Yoga treatment

Other Intervention Name(s)

Kripalu Yoga

Intervention Description

The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions. In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.

Primary Outcome Measure Information:

Title

Clinician Administered PTSD Scale (CAPS)

Time Frame

pre-intervention and 10 weeks

Secondary Outcome Measure Information:

Title

PTSD Checklist Military Version (PCL-M)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Impact of Events Scale - Revised (IES-R)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

25-item Resilience Scale (RS)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Twenty-four-hour urinary samples

Time Frame

pre-intervention and 3 months post intervention

Title

10-minute segment of a seated 30-minute electrocardiogram recording session

Time Frame

pre-intervention and 3 months post intervention

Title

Beck Depression Inventory (BDI)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Spielberger State Trait Anxiety Inventory (STAI)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Daily Sleep Wake Diaries

Time Frame

during intervention (weeks 1-10) and 3 months post intervention

Title

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Credibility Expectancy Questionnaire (CEQ)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Body-Oriented State Questionnaire (BOSC)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

5-Facet Mindfulness Questionnaire (FFMQ)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Perceived Stress Scale (PSS)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

Title

Yoga Follow-up Questionnaire

Time Frame

3 months post intervention

Title

PTSD Checklist Civilian Version (PCL-C)

Time Frame

pre-intervention, 5 weeks, 10 weeks and 3 months post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female military veterans and active duty military personnel aged 18 and older A DSM IV diagnosis of post-traumatic stress disorder Potential subjects on medications are eligible to participate in the study Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga) Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process Exclusion Criteria: Potential subjects are ineligible if pregnant and in their third trimester. Potential subjects are ineligible if they are confined to a wheel chair.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sat Bir S Khalsa, Ph.D.

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jennifer Johnston, MA, LMHC

Organizational Affiliation

Northeastern University

Official's Role

Study Director

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16281237

Citation

van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.

Results Reference

background

PubMed Identifier

16507803

Citation

Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.

Results Reference

background

PubMed Identifier

11681550

Citation

Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.

Results Reference

background

PubMed Identifier

16891578

Citation

van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.

Results Reference

background

Citation

Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.

Results Reference

background

PubMed Identifier

6590525

Citation

Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.

Results Reference

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Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder

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