Distress
Conditions
Brief summary
Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.
Detailed description
In Phase 1.2, the investigators will conduct an open single-arm pilot trial of a 12 week adapted integrative hatha yoga and self-compassion program. The investigators will enroll 15 women survivors of interpersonal violence in the open pilot trial.
Interventions
BEHAVIORALIntegrative hatha yoga and mindful self-compassion
12 weeks of integrative hatha yoga and mindful self-compassion training
Sponsors
Butler Hospital
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 |
|---|---|---|
| Participant Retention - 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, constituting the score range. Higher scores indicate greater feasibility. |
| Intervention Appropriateness Measure | Post intervention (month 3) | The Intervention Appropriateness Measure (IAM) construct constitutes four items with each item measured on a 1-5 scale, comprising the total score range. Higher scores indicate greater intervention appropriateness. |
| 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, constituting the total score range. Higher scores indicate greater acceptability. |
| 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. |
| Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | Mid intervention (month 1.5) and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety and Stress Scale (DASS-21) | 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
Participant flow
Recruitment details
Participant recruitment started September 10 2024 and completed on March 6, 2025. Participants were recruited from both clinical settings and community advertisements.
Pre-assignment details
All enrolled participants in this open pilot trial were assigned to the integrative yoga and mindful self-compassion arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Depression, Anxiety, and Stress Scale (DASS-21) | 41.45 Units on a scale STANDARD_DEVIATION 24.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 4 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
None listed