Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
NCT ID: NCT01521442
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2013-04-30
2015-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Arm 1
12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Mindful Yoga Therapy
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.
Arm 2
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.
Wait-list Control
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.
Interventions
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Mindful Yoga Therapy
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.
Wait-list Control
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.
Eligibility Criteria
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Inclusion Criteria
* Ages 18-45
* Currently enrolled in active PTSD treatment
* Meet criteria for PTSD
* Veteran with combat exposure during deployment
Exclusion Criteria
* Current use of beta-blocker medication
* Current regular yoga or meditation practice in the past month
* Significant limitations or injuries
18 Years
45 Years
ALL
No
Sponsors
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VA Connecticut Healthcare System
FED
Responsible Party
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Principal Investigators
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Alicia Heapy, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System
Locations
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VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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Other Identifiers
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01540
Identifier Type: -
Identifier Source: org_study_id