Distress, Psychological
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntegrative Yoga & Mindful Self-Compassion training
Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
BEHAVIORALWomen's Wellbeing Education
Group women's wellbeing education for women with a history of interpersonal violence exposure and distress
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Female 2. Ages 18-65 3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\]) 4. Report being distressed, defined by a score of \>5 on the Kessler-6 screener 5. Speak and understand English well enough to understand questionnaires when they are read aloud 6. Have access to a telephone through owning one, a relative/friend, or an agency 7. Have access to a device that will support use of the video platform we are using to conduct assessments and for home practice yoga video sessions
Exclusion criteria
1. Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation 2. Planned surgery in next 6 months, as this would interfere with study participation 3. Pregnancy, as yoga should be modified for pregnancy Women who meet criteria for the following: 4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) 5. Lifetime history of psychotic disorders (DIAMOND) 6. Current probable severe substance use disorder (DIAMOND) 7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND) 8. 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 9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks 10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes 11. 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 12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Appropriateness Measure | Post intervention (month 3) | 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. |
| Feasibility | Post intervention (month 3) | Feasibility assessed based on number of participants who remained in the intervention (retention). |
| Feasibility of Intervention Measure | Post intervention (month 3) | 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. |
| Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | Post intervention (month 3) | 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. |
| Acceptability of Intervention Measure | Post intervention (month 3) | 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. |
| The Client Satisfaction Questionnaire (CSQ-8) | Post intervention (month 3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety and Stress Scale (DASS-21) | Baseline to post intervention (month 3) | 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. |
Countries
United States
Outcome results
None listed