Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
Primary Purpose
PTSD
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mindful Yoga Therapy
Wait-list Control
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring PTSD, Yoga, Complementary and Alternative Medicine (CAM)
Eligibility Criteria
Inclusion Criteria:
- OEF/OIF/OND Veteran
- Ages 18-45
- Currently enrolled in active PTSD treatment
- Meet criteria for PTSD
- Veteran with combat exposure during deployment
Exclusion Criteria:
- Current psychotic disorder or bipolar disorder
- Current use of beta-blocker medication
- Current regular yoga or meditation practice in the past month
- Significant limitations or injuries
Sites / Locations
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm 1
Arm 2
Arm Description
12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
The "gold standard" measure of frequency and intensity of PTSD symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT01521442
First Posted
January 19, 2012
Last Updated
December 18, 2014
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01521442
Brief Title
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
Official Title
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Did not have funding or resources to carry out study
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.
Detailed Description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT)is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot randomized clinical trial with cross-over waitlist comparison (RCT) will compare Immediate Mindful Yoga Therapy (MYT) plus Treatment as Usual (TAU) with Delayed MYT + TAU. Baseline (week 0), 12-week, and 24-week assessments, in addition to 36-week assessments for the delayed MYT treatment group, will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to treatment condition.
Primary Aim: The primary aim of the current pilot study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for PTSD among OEF/OIF Veterans.
Specific Aim #1: To establish that MYT is a treatment that can be implemented safely. Hypothesis #1: There will be no significant difference in the number of adverse events between treatment groups from week 0 to week 12.
Specific Aim #2: To establish that MYT is a treatment that veterans find helpful and accessible. Hypothesis #2. At least 50% of participants completing the MYT treatment will report that the treatment was helpful and accessible as reported on self-report measures of treatment satisfaction, administered at the completion of the MYT treatment component of the study (week 12 for the immediate MYT treatment group; week 24 for the delayed MYT treatment group).
Secondary Aim: To assess the effect of Mindful Yoga Therapy as an adjunctive treatment on symptoms of PTSD is OEF/OIF Veterans.
Specific Aim #3: To examine the efficacy of MYT + TAU in reducing frequency and/or intensity of PTSD symptoms. Hypothesis #3. While both groups are expected to show reductions in symptoms, compared to participants in the Delayed MYT + TAU group, Veterans in the Immediate MYT + TAU group will exhibit significantly greater reductions in the frequency and/or intensity of PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS) (baseline to 12-week change). We predict that Immediate MYT+TAU will have a differential impact on the three PTSD symptom clusters, with the greatest effect on the hyperarousal symptoms.
Specific Aim #4. To document the durability of MYT treatment effects in the Immediate MYT group. Hypothesis #4. PTSD symptom scores will not be significantly different at 24-week assessment compared to those at week 12 assessment in the immediate MYT treatment group, and not significantly different at 36-week assessment compared to 24-week assessment for the delayed treatment group.
Tertiary Aim: To assess changes in heart rate variability from a resting baseline period and a guided meditation period in Veterans with PTSD before and after treatment with Mindful Yoga Therapy.
Specific Aim #5: To examine the predictive value of HRV on outcomes of Immediate MYT+TAU and Delayed MYT + TAU. Hypothesis #5. Increases in high frequency HRV (HF-HRV) from resting baseline to guided meditation at the pre-treatment assessment (week 0 for the immediate MYT treatment group, week 12 for the delayed MYT treatment group) will be associated with greater PTSD symptom reduction at post-treatment (week 12 for the immediate MYT treatment group; week 24 for delayed MYT treatment group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, Yoga, Complementary and Alternative Medicine (CAM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Arm Title
Arm 2
Arm Type
Other
Arm Description
12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Yoga Therapy
Intervention Description
Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Intervention Type
Behavioral
Intervention Name(s)
Wait-list Control
Intervention Description
Participants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
The "gold standard" measure of frequency and intensity of PTSD symptoms.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OEF/OIF/OND Veteran
Ages 18-45
Currently enrolled in active PTSD treatment
Meet criteria for PTSD
Veteran with combat exposure during deployment
Exclusion Criteria:
Current psychotic disorder or bipolar disorder
Current use of beta-blocker medication
Current regular yoga or meditation practice in the past month
Significant limitations or injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Heapy, Ph.D.
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
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Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
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