BridgeMD
New treatment option for Distress, Psychological
Official title Women's Wellbeing Study
ClinicalTrials.gov ID: NCT07195019
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Female
- Ages 18-65
- Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History...
- 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
You likely can't join if
- Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of...
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.