RECRUITING

Women's Wellbeing Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Treatments for Improving Mood in Women

Quick Facts

Study Start:2025-08-27

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07195019

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female 2. Ages 18-65 3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\]) 4. Report being distressed, defined by a score of \>5 on the Kessler-6 screener 5. Speak and understand English well enough to understand questionnaires when they are read aloud 6. Have access to a telephone through owning one, a relative/friend, or an agency 7. 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	1. Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation 2. Planned surgery in next 6 months, as this would interfere with study participation 3. Pregnancy, as yoga should be modified for pregnancy 4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) 5. Lifetime history of psychotic disorders (DIAMOND) 6. Current probable severe substance use disorder (DIAMOND) 7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND) 8. 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 9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks 10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes 11. 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 12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions

Inclusion Criteria

Exclusion Criteria

1. Female
2. Ages 18-65
3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\])
4. Report being distressed, defined by a score of \>5 on the Kessler-6 screener
5. Speak and understand English well enough to understand questionnaires when they are read aloud
6. Have access to a telephone through owning one, a relative/friend, or an agency
7. 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

1. Inability to be physically active, determined by a score \>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
2. Planned surgery in next 6 months, as this would interfere with study participation
3. Pregnancy, as yoga should be modified for pregnancy
4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
5. Lifetime history of psychotic disorders (DIAMOND)
6. Current probable severe substance use disorder (DIAMOND)
7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
8. 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
9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
11. 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
12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions

Contacts and Locations

Study Locations (Sites)

Butler Hospital

Providence, Rhode Island, 02906

United States

Collaborators and Investigators

Sponsor: Butler Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2025-08-27

Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

Distress, Psychological