Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/7/2015 |
| Start Date: | April 2013 |
| End Date: | November 2015 |
| Contact: | Rebecca A Czlapinski, M.A. |
| Email: | rebecca.czlapinski@va.gov |
| Phone: | 203.932.5711 |
Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study
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.
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.
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).
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).
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
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