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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Information about local and national complementary and integrative health programs |
|
| Yoga and meditation | Experimental | Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program |
|
| Wellness | Experimental | Weekly exercise/nutrition classes to support lifestyle changes |
|
| Positive affect | Experimental | Weekly classes focused on increasing positive affect and social support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga and meditation | Behavioral | 12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inventory of Psychosocial Functioning (IPF) | The IPF is a self-report measure of functioning across several domains. It is summarized in a mean score with higher scores indicating greater functional impairment. | weeks 0, 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R) | The CAPS-5R is a clinician-administered measure of PTSD symptom severity summarized in a total score with higher scores indicating greater symptom severity. | weeks 0, 12 and 24 |
| Quick Inventory of Depressive Symptomatology (QIDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariel J Lang, PhD, MPH | Contact | 858-552-8585 | x5359 | ariel.lang@va.gov |
| Haley Suit, MA | Contact | haley.suit@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Central Arkansas Healthcare System | Not yet recruiting | Little Rock | Arkansas | 72205-5446 | United States |
Deidentified datasets will be made available via National Institutes of Mental Health Data Archive (NDA). The study protocol, statistical analysis plan and ICF/HIPAA form will be available on clinical.trials.gov.
Data and supporting information will be available within 1 year of the conclusion of the trial and archived according to the standards of the hosting archives.
Unique research resources will be readily available for research purposes to members of academic institutions, non-profit organizations, and commercial partners after the completion of data analysis, presentations, and publications
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| 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 |
| D019122 | Meditation |
| D006262 | Health |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Wellness | Behavioral | 12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes |
|
| Positive affect | Behavioral | 12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection |
|
| Information | Other | Provision of written information about local and national complementary and integrative care resources |
|
The QIDS is a self-report measure of depression severity summarized by a total score for which higher scores reflect greater symptom severity. |
| weeks 0, 12 and 24 |
| Insomnia Severity Index (ISI) | The ISI is a self-report measure that assesses the consequences of and distress related to insomnia summarized by a total score in which higher scores indicate greater sleep disruption. | weeks 0, 12 and 24 |
| VA San Diego Healthcare System | Recruiting | San Diego | California | 92161 | United States |
|
| Durham VA Healthcare System | Not yet recruiting | Durham | North Carolina | 27705 | United States |
|
| VA Portland Healthcare System | Recruiting | Portland | Oregon | 97239-2964 | United States |
|
| VA North Texas Healthcare System | Recruiting | Dallas | Texas | 75216-7167 | United States |
|
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011154 | Population Characteristics |