CompletedNot Applicable

Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2

United States11 participantsStarted 2024-09-10

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. Ages 18-65
✓. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\])
✓. Report being distressed, defined by a score of \>5 on the Kessler-6 screener
✓. Speak and understand English well enough to understand questionnaires when they are read aloud
✓. Have access to a telephone through owning one, a relative/friend, or an agency
✓. 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

✕. 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
✕. 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

What they're measuring

Feasibility

Timeframe: Post intervention (month 3)

Feasibility of Intervention Measure

Timeframe: Post intervention (month 3)

Intervention Appropriateness Measure

Timeframe: Post intervention (month 3)

Acceptability of Intervention Measure

Timeframe: Post intervention (month 3)

The Client Satisfaction Questionnaire (CSQ-8)

Timeframe: Post intervention (month 3)

Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)

Timeframe: Mid intervention (month 1.5) and Post intervention (month 3)

Trial details

NCT IDNCT06657950

SponsorButler Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

View on ClinicalTrials.gov More Distress trials

Who can participate

Age range18 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. Ages 18-65
✓. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\])
✓. Report being distressed, defined by a score of \>5 on the Kessler-6 screener
✓. Speak and understand English well enough to understand questionnaires when they are read aloud
✓. Have access to a telephone through owning one, a relative/friend, or an agency
✓. 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

✕. 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
✕. 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

What they're measuring

Feasibility

Timeframe: Post intervention (month 3)

Feasibility of Intervention Measure

Timeframe: Post intervention (month 3)

Intervention Appropriateness Measure

Timeframe: Post intervention (month 3)

Acceptability of Intervention Measure

Timeframe: Post intervention (month 3)

The Client Satisfaction Questionnaire (CSQ-8)

Timeframe: Post intervention (month 3)

Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)

Timeframe: Mid intervention (month 1.5) and Post intervention (month 3)