Health TrialsbyHealthPanel

Women's Wellbeing Study

ConditionDistress, Psychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorButler Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Women's Wellbeing Education

    Behavioral

    Group women's wellbeing education for women with a history of interpersonal violence exposure and distress

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Integrative Yoga and Mindful Self-Compassion (I-YMSC) trainingExperimental treatment 1 intervention
Group B: Women's Wellbeing Education (WWE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

Feasibility assessed based on number of participants who remained in the intervention (retention).

Time frame
Post intervention (month 3)
2

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.

Time frame
Post intervention (month 3)
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.

Time frame
Post intervention (month 3)
4

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.

Time frame
Post intervention (month 3)

Secondary outcomes

1

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.

Time frame
Baseline to post intervention (month 3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Butler Hospital

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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