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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003905-01A2 | U.S. NIH Grant/Contract | View source | |
| 1R21AT003905-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The central question in this research proposal is: can a popular technique that specifically targets active mastery and improved affect regulation, yoga, which is utilized by approximately 4% of the US population each year (1), improve the constellation of PTSD symptoms, multiple somatic complaints, social and occupational impairment and high health care utilization that has been documented in hundreds of thousands of women in the US?
The Primary Aims of this study include the following:
Research has demonstrated a close association between trauma exposure and 1) PTSD, anxiety & depression, 2) loss of affect regulation, 3) poor quality of life, and 4) high health care utilization (2, 3). This study will explore how a popular body-mind technique, yoga, compares with a attentional control group condition, Women's Health Education (WHE), in the treatment of [heretofore treatment- unresponsive adults with] PTSD, and measure whether yoga can affect "the attitudes and beliefs" that "can reduce psychological stress and contribute to positive health outcomes." [The study of yoga for chronic PTSD is in line with the empirical research that supports the notion that autonomic dysregulation plays a significant role in the persistence of PTSD (4), and with the hypothesis that an increased capacity for self-regulation is associated with a decrease in the severity of this symptom constellation].
Primary aims.
Primary Hypotheses:
Participants in the yoga condition will demonstrate a clinically significant reduction in PTSD symptoms at post-treatment, defined as a mean reduction of total CAPS score of at least 30% compared to baseline.
Yoga will be more effective than attention control at improving PTSD symptoms as evidenced by a significantly greater drop in total CAPS score from pre-treatment to post-treatment for the yoga group.
Secondary Hypotheses:
Yoga will be more effective at improving comorbid conditions and quality of life and reducing health care utilization than attention control.
Yoga will be more effective than attention control at improving HRV and body awareness.]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga | Experimental | 10 week trauma-sensitive yoga classes |
|
| Women's Health Education | No Intervention | 10 weeks of women's health education classes as an attentional control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | 10 weeks of a trauma-sensitive yoga class |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS 1) | Initial Assessment | |
| Clinician Administered PTSD Scale (CAPS 1) | One week Pre-Treatment Evaluation | |
| Clinician Administered PTSD Scale (CAPS 1) | One week Post-treatment | |
| Clinician Administered PTSD Scale (CAPS 1) | 2 month-follow-up Evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Initial Assessment, week 1 of treatment, week 2 of treatment, week 5 of treatment, week 9 of treatment, week 10 of treatment, one week post-treatment, 2 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regina Musicaro, BA | Contact | 617-232-1303 | 310 | rmusicaro@traumacenter.org |
| Joseph Spinazzola, Ph.D. | Contact | 617-232-1303 | jspinazzola@jri.org |
| Name | Affiliation | Role |
|---|---|---|
| Bessel van der Kolk, M.D. | The Trauma Center at JRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Trauma Center at JRI | Recruiting | Brookline | Massachusetts | 02446 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32853015 | Derived | Nguyen-Feng VN, Hodgdon H, Emerson D, Silverberg R, Clark CJ. Moderators of treatment efficacy in a randomized controlled trial of trauma-sensitive yoga as an adjunctive treatment for posttraumatic stress disorder. Psychol Trauma. 2020 Nov;12(8):836-846. doi: 10.1037/tra0000963. Epub 2020 Aug 27. | |
| 25004196 | Derived | van der Kolk BA, Stone L, West J, Rhodes A, Emerson D, Suvak M, Spinazzola J. Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial. J Clin Psychiatry. 2014 Jun;75(6):e559-65. doi: 10.4088/JCP.13m08561. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2017 | |
| Reset | May 3, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2017 | May 3, 2017 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |