DistressI-YMSCNCT06657950
Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2
A study testing Integrative hatha yoga and mindful self-compassion in people with Distress, run by Butler Hospital at 1 site in United States.
Trial summary
Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Distress
- What is being tested?
- Integrative hatha yoga and mindful self-compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
About this study
Official title: Adaptation and Pilot Study of Integrative Yoga and Mindful Self-Compassion (I-YMSC) to Improve Mood in Women Survivors of Interpersonal Violence
Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.
Read the detailed description
In Phase 1.2, the investigators will conduct an open single-arm pilot trial of a 12 week adapted integrative hatha yoga and self-compassion program.
The investigators will enroll 15 women survivors of interpersonal violence in the open pilot trial.
- Conditions
- Distress
- Being tested
- Integrative hatha yoga and mindful self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative hatha yoga and mindful self-compassionBehavioural
12 weeks of integrative hatha yoga and mindful self-compassion training
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Integrative hatha yoga and mindful self-compassion | Experimental | 12 weeks of adapted, integrative yoga and mindful self-compassion specifically designed to be administered to women survivors of interpersonal violence. Receives: Behavioral: Integrative hatha yoga and mindful self-compassion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention - 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, constituting the score range. Higher scores indicate greater feasibility.
Measured: Post intervention (month 3)
Intervention Appropriateness Measure
The Intervention Appropriateness Measure (IAM) construct constitutes four items with each item measured on a 1-5 scale, comprising the total score range. Higher scores indicate greater intervention appropriateness.
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, constituting the total score range. Higher scores indicate greater acceptability.
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: Mid intervention (month 1.5) and 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: 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 Oct 2024
- Study start10 Sep 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DistressStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT06657950
- Sponsor's protocol ID
- 2203-003 Open
- Other IDs
- K23AT011917
- Acronym
- I-YMSC
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2024
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Study of Integrative Yoga and Mindful Self-Compassion (I-YMSC) to Improve Mood in Women Survivors of Interpersonal Violence
- ClinicalTrials.gov ID
- NCT06657950
- Acronym / sponsor ID
- I-YMSC / 2203-003 Open
- Conditions
- Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1.2: Open Trial N=15 women survivors of interpersonal violence will be enrolled into a single-arm pilot trial to test the adapted integrative hatha yoga and mindful self-compassion program.
Detailed description
In Phase 1.2, the investigators will conduct an open single-arm pilot trial of a 12 week adapted integrative hatha yoga and self-compassion program.
The investigators will enroll 15 women survivors of interpersonal violence in the open pilot trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Integrative hatha yoga and mindful self-compassion | Experimental | Behavioral: Integrative hatha yoga and mindful self-compassion12 weeks of adapted, integrative yoga and mindful self-compassion specifically designed to be administered to women survivors of interpersonal violence. |
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 hatha yoga and mindful self-compassion12 weeks of integrative hatha yoga and mindful self-compassion training | Behavioural | Experimental: Integrative hatha yoga and mindful self-compassion |
Primary outcome
Participant Retention - 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, constituting the score range. Higher scores indicate greater feasibility.
Intervention Appropriateness Measure
Time frame: Post intervention (month 3)
The Intervention Appropriateness Measure (IAM) construct constitutes four items with each item measured on a 1-5 scale, comprising the total score range. Higher scores indicate greater intervention appropriateness.
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, constituting the total score range. Higher scores indicate greater acceptability.
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: Mid intervention (month 1.5) and 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: Post intervention (month 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 hatha yoga and mindful self-compassion in people with Distress, 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: finished, as of the sponsor's last update on 25 Jun 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?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention - 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 25 Jun 2026.