Evaluation of Yoga for Sleep Disturbances in Post Traumatic Stress Disorder (PTSD)

NCT ID: NCT01556074

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-02-28

Brief Summary

The primary objective of this preliminary study is to estimate sleep outcome effect sizes and determine feasibility for a novel yoga treatment of insomnia in participants with post traumatic stress disorder (PTSD). Additional objectives are to evaluate relationships of sleep outcomes with measures of other PTSD symptoms, psychosocial health and possible mechanisms of action.

Conditions

Post Traumatic Stress Disorder; Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yoga treatment

Group Type: EXPERIMENTAL

Yoga treatment

Intervention Type: BEHAVIORAL

Biweekly 90-minute group yoga classes for 8 weeks and on non-class days participants will be asked to devote 15 minutes per day to a prescribed home yoga practice.

Interventions

Yoga treatment

Biweekly 90-minute group yoga classes for 8 weeks and on non-class days participants will be asked to devote 15 minutes per day to a prescribed home yoga practice.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and non-pregnant female adults at least 18 years of age.
• A DSM-IV-TR diagnosis of post-traumatic stress disorder (PTSD).
• Naïve to yoga and other meditative practices, defined as less than one hour per week for the past 6 months.
• Potential subjects receiving ongoing medical or psychological treatment are eligible, as long as treatment remains stable over the course of the study and does not include more than one hour weekly of mind-body medicine (strategies directly related to meditation and yoga).
• No more than 2 alcoholic or caffeinated drinks/day
• No illicit drug use
• Potential subjects are eligible if they have been on stable dosage (not PRN) of medication for PTSD symptoms including sleep disturbances and any medication that may influence sleep for at least 6 weeks prior to the study, and be willing to continue with same dosage for the duration of the study.
• No current substance abuse, defined as diagnosis of substance abuse or dependence disorder within the past year, and/or in/outpatient treatment for substance abuse or dependence in the past 6 weeks.
• No transcontinental travel over the course of the study.
• No night-shift or rotating shift work over the course of the study.
• Insomnia based on the American Academy of Sleep Medicine's Research Diagnostic Criteria (RDC) for insomnia due to a mental health disorder
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sat Bir Khalsa, PhD

Assistant Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica J Noggle Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Sat Bir S Khalsa, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

F32AT006092-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18180

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012P000263

Identifier Type: -

Identifier Source: org_study_id