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Recruiting NCT07195019

Women's Wellbeing Study

No phase Interventional Distress, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrative Yoga & Mindful Self-Compassion training, Women's Wellbeing Education.
Who it may be relevant to
Registry conditions: Distress, Psychological. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatments for Improving Mood in Women

Overview

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

  • Behavioral Integrative Yoga & Mindful Self-Compassion training
    Group Integrative Yoga \& Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
  • Behavioral Women's Wellbeing Education
    Group women's wellbeing education for women with a history of interpersonal violence exposure and distress

Primary outcome measures

  • Feasibility [Time frame: Post intervention (month 3)]
  • Feasibility of Intervention Measure [Time frame: Post intervention (month 3)]
  • Intervention Appropriateness Measure [Time frame: Post intervention (month 3)]
  • Acceptability of Intervention Measure [Time frame: Post intervention (month 3)]
  • The Client Satisfaction Questionnaire (CSQ-8) [Time frame: Post intervention (month 3)]
  • Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) [Time frame: Post intervention (month 3)]
Secondary outcome measures (1)
  • Depression Anxiety and Stress Scale (DASS-21) [Time frame: Baseline to post intervention (month 3)]

Eligibility criteria

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

Women who meet criteria for the following:

  • 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
  • Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
  • Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
  • 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
  • Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Butler Hospital — Providence

Identifiers

NCT: NCT07195019 · 1871144-2 · K23AT011917

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗