Trial Outcomes & Findings for Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2 (NCT NCT06657950)
NCT ID: NCT06657950
Last Updated: 2026-06-25
Results Overview
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.
COMPLETED
NA
11 participants
Post intervention (month 3)
2026-06-25
Participant Flow
Participant recruitment started September 10 2024 and completed on March 6, 2025. Participants were recruited from both clinical settings and community advertisements.
All enrolled participants in this open pilot trial were assigned to the integrative yoga and mindful self-compassion arm.
Participant milestones
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2
Baseline characteristics by cohort
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=11 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=20 Participants
|
|
Depression, Anxiety, and Stress Scale (DASS-21)
|
41.45 Units on a scale
STANDARD_DEVIATION 24.87 • n=20 Participants
|
PRIMARY outcome
Timeframe: Post intervention (month 3)Feasibility assessed based on number of participants who remained in the intervention (retention).
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=11 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Participant Retention - Feasibility
|
9 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=9 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Feasibility of Intervention Measure
|
4.86 Units on a scale
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=9 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Intervention Appropriateness Measure
|
4.89 Units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=9 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Acceptability of Intervention Measure
|
4.94 Units on a scale
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=9 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
The Client Satisfaction Questionnaire (CSQ-8)
|
31.44 Units on a scale
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=9 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
|
6 Adverse events
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=11 Participants
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
|
17.78 Units on a scale
Standard Deviation 18.45
|
Adverse Events
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Integrative Hatha Yoga and Mindful Self-compassion
n=11 participants at risk
12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back injury
|
18.2%
2/11 • From enrollment until end of follow-up, up to 4 months
|
|
Immune system disorders
Allergic reaction
|
9.1%
1/11 • From enrollment until end of follow-up, up to 4 months
|
|
Gastrointestinal disorders
GI distress
|
9.1%
1/11 • From enrollment until end of follow-up, up to 4 months
|
|
General disorders
High iron levels
|
9.1%
1/11 • From enrollment until end of follow-up, up to 4 months
|
|
Social circumstances
Physical altercation
|
9.1%
1/11 • From enrollment until end of follow-up, up to 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place