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

This study has been completed.
Sponsor:
Collaborators:
Brain and Behavior Research Foundation
Information provided by (Responsible Party):
Jessica J Noggle Taylor, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01556074
First received: March 8, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Post Traumatic Stress Disorder
Insomnia
Behavioral: Yoga treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Yoga for Sleep Disturbances in Insomnia and Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in sleep quality measured by wrist actigraphy and daily sleep diaries [ Time Frame: Averages of: 2-week pre-treatment baseline; last 2 weeks of treatment; 2-week long-term follow-up occuring 3-months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of yoga program as measured by a 2-item Yoga Evaluation Form (End) and a 2-item Yoga Evaluation Form (Followup) [ Time Frame: One occurrence at 1 week following intervention, one occurrence at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Treatment adherence as measured by attendance to group yoga classes and play count monitoring of mp3's for home practice on non-class days [ Time Frame: Averages over duration of intervention (8 weeks total) ] [ Designated as safety issue: No ]
  • Accrual rate calculated from recruitment and consent information [ Time Frame: Monthly for duration of recruitment period (expected to be 3 months per cohort, up to 6 to 9 months for 2 to 3 cohorts total) ] [ Designated as safety issue: No ]
  • Attrition rate calculated from disempanelment information [ Time Frame: Monthly for duration of data collection and treatment (approximately 6 months per cohort, up to 18 months for 2 to 3 cohorts total) ] [ Designated as safety issue: No ]
  • Change in PTSD symptoms as measured by the 17-item, self-reported PTSD Checklist-- Civilian version (PCL-C) [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in 10-min segment of a seated 30-min electrocardiogram (ECG) recording [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in emotional distress as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for anxiety (4 items), depression (4 items) and anger (8 items) [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in social health as measured by short forms of the Patient Reported Outcomes Measurement System (PROMIS) instruments for social functioning (4 items), social functioning satisfaction (4 items) and social isolation (6 items) [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in interoception as measured by the 32-item self-reported Multidimensional Assessment of Interoceptive Awareness scale (MAIA) [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in emotion regulation as measured by the Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]
  • Change in sleep disturbance and sleep-related impairment as measured by two PROMIS scales [ Time Frame: Once at 1-week before intervention, once at 1 week post-intervention, once at 3 months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga treatment Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556074

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Brigham and Women's Hospital
Brain and Behavior Research Foundation
Investigators
Principal Investigator: Jessica J Noggle, PhD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Jessica J Noggle Taylor, PhD, Research Fellow in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01556074     History of Changes
Other Study ID Numbers: 2012P000263, F32AT006092-01A1, 18180
Study First Received: March 8, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board
United States: Data Safety and Monitoring Board

Keywords provided by Brigham and Women's Hospital:
Post traumatic stress disorder
PTSD
Insomnia
Sleep
Yoga
Meditation
Mental Health
Sleep Quality
Actigraphy
Sleep Diaries
Autonomic
Social Health
Interoception
Attention Regulation
Emotion Regulation

Additional relevant MeSH terms:
Sleep Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Sleep Initiation and Maintenance Disorders
Nervous System Diseases
Mental Disorders
Anxiety Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Parasomnias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014