Distress, PsychologicalNCT07195019
Women's Wellbeing Study
A study testing Integrative Yoga & Mindful Self-Compassion training and Women's Wellbeing Education in people with Distress, Psychological, run by Butler Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Distress, Psychological
- What is being tested?
- Integrative Yoga & Mindful Self-Compassion training and Women's Wellbeing Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Butler Hospital
Providence, Rhode Island, 02906
Research Coordinator, 401-455-6200, ext. 21070, i-ymsc.study@butler.org
About this study
Official title: Treatments for Improving Mood in Women
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.
Read the 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.
- Conditions
- Distress, Psychological
- Being tested
- Integrative Yoga & Mindful Self-Compassion training, Women's Wellbeing Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Yoga & Mindful Self-Compassion trainingBehavioural
Group Integrative Yoga \& Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
Women's Wellbeing EducationBehavioural
Group women's wellbeing education for women with a history of interpersonal violence exposure and distress
| Study group | Role | What they receive |
|---|---|---|
| Integrative Yoga and Mindful Self-Compassion (I-YMSC) training | Experimental | 12 weeks of I-YMSC training Receives: Behavioral: Integrative Yoga & Mindful Self-Compassion training |
| Women's Wellbeing Education (WWE) | Active comparator | 12 weeks of group WWE Receives: Behavioral: Women's Wellbeing Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility assessed based on number of participants who remained in the intervention (retention).
Measured: Post intervention (month 3)
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.
Measured: Post intervention (month 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.
Measured: Post intervention (month 3)
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.
Measured: Post intervention (month 3)
The Client Satisfaction Questionnaire (CSQ-8)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Measured: Post intervention (month 3)
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
Measured: 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.
Measured: Baseline to post intervention (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start27 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195019
- Sponsor's protocol ID
- 1871144-2
- Other IDs
- K23AT011917
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments for Improving Mood in Women
- ClinicalTrials.gov ID
- NCT07195019
- Acronym / sponsor ID
- 1871144-2
- Conditions
- Distress, Psychological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Yoga and Mindful Self-Compassion (I-YMSC) training | Experimental | Behavioral: Integrative Yoga & Mindful Self-Compassion training12 weeks of I-YMSC training |
| Women's Wellbeing Education (WWE) | Active comparator | Behavioral: Women's Wellbeing Education12 weeks of group WWE |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Yoga & Mindful Self-Compassion trainingGroup Integrative Yoga \& Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress | Behavioural | Integrative Yoga and Mindful Self-Compassion (I-YMSC) training |
| Women's Wellbeing EducationGroup women's wellbeing education for women with a history of interpersonal violence exposure and distress | Behavioural | Women's Wellbeing Education (WWE) |
Primary outcome
Feasibility
Time frame: Post intervention (month 3)
Feasibility assessed based on number of participants who remained in the intervention (retention).
Feasibility of Intervention Measure
Time frame: Post intervention (month 3)
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.
Intervention Appropriateness Measure
Time frame: Post intervention (month 3)
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.
Acceptability of Intervention Measure
Time frame: Post intervention (month 3)
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.
The Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post intervention (month 3)
Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Time frame: Post intervention (month 3)
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
1 secondary outcome
Depression Anxiety and Stress Scale (DASS-21)
Time frame: Baseline to post intervention (month 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Yoga & Mindful Self-Compassion training and Women's Wellbeing Education in people with Distress, Psychological, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Post intervention (month 3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.