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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011917 | 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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Phase 2 is a randomized controlled trial of integrative yoga and mindful self-compassion program vs. women's wellbeing education for women with a history of interpersonal violence exposure and heightened distress.
In Phase 2, the investigators will conduct a pilot randomized controlled trial (RCT) of 12 weeks of integrative yoga and mindful self-compassion training (I-YMSC) vs. 12 weeks of women's wellbeing education (WWE).
Participants will be women with a history of interpersonal violence exposure and heightened distress.
Participants will be randomized to Phase 2 groups of 12 weeks of I-YMSC or WWE. Forty-eight women will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative Yoga and Mindful Self-Compassion (I-YMSC) training | Experimental | 12 weeks of I-YMSC training |
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| Women's Wellbeing Education (WWE) | Active Comparator | 12 weeks of group WWE |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Yoga & Mindful Self-Compassion training | Behavioral | Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility assessed based on number of participants who remained in the intervention (retention). | Post intervention (month 3) |
| Feasibility of Intervention Measure | The Feasibility of Intervention Measure (FIM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. | Post intervention (month 3) |
| Intervention Appropriateness Measure | The Intervention Appropriateness Measure (IAM) construct comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. | Post intervention (month 3) |
| Acceptability of Intervention Measure | The Acceptability of Intervention Measure (AIM) comprises four items with each item measured on a 1-5 scale. The total score range is from 4-20. Higher scores indicate greater feasibility. | Post intervention (month 3) |
| The Client Satisfaction Questionnaire (CSQ-8) | Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction. | Post intervention (month 3) |
| Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Anxiety and Stress Scale (DASS-21) | Distress at Month 3. The DASS-21 is a 21-item measure with each item measured on a 0-3 scale, and total score conversion ranging from 0-63. Higher global scores indicate greater psychological distress. | Baseline to post intervention (month 3) |
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Inclusion Criteria:
Exclusion Criteria:
Inability to be physically active, determined by a score >1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
Planned surgery in next 6 months, as this would interfere with study participation
Pregnancy, as yoga should be modified for pregnancy
Women who meet criteria for the following:
Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Lifetime history of psychotic disorders (DIAMOND)
Current probable severe substance use disorder (DIAMOND)
Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
Moderate or high risk for suicide on the adapted Columbia Suicide Severity Rating Scale screen version-recent (C-SSRS) and/or endorsement of suicidal plan/intent in the past 3 months
Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
Self-report of experiencing intimate partner violence currently or within past six months (assessed by the Revised Conflict Tactics Scale 2 [R-CTS2]), as this would require a different type of intervention
Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
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| Women's Wellbeing Education | Behavioral | Group women's wellbeing education for women with a history of interpersonal violence exposure and distress |
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| Post intervention (month 3) |