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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011917 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative hatha yoga and mindful self-compassion | Behavioral | 12 weeks of integrative hatha yoga and mindful self-compassion training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention - Feasibility | Feasibility assessed based on number of participants who remained in the intervention (retention). | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post intervention (month 3) |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 06442 | United States |
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All enrolled participants in this open pilot trial were assigned to the integrative yoga and mindful self-compassion arm.
Participant recruitment started September 10 2024 and completed on March 6, 2025. Participants were recruited from both clinical settings and community advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Integrative Hatha Yoga and Mindful Self-compassion | 12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Integrative Hatha Yoga and Mindful Self-compassion | 12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Retention - Feasibility | Feasibility assessed based on number of participants who remained in the intervention (retention). | Posted | Count of Participants | Participants | Post intervention (month 3) |
|
|
From enrollment until end of follow-up, up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Integrative Hatha Yoga and Mindful Self-compassion | 12 weeks of adapted, integrative yoga and mindful self-compassion developed for women survivors of interpersonal violence. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Event 1: Not related to intervention, mild severity, unexpected; Event 2: Unlikely related to intervention, severe, unexpected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tosca Braun | Butler Hospital | (401)455-6219 | i-ymsc.study@butler.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2025 | May 30, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2025 | May 30, 2026 | ICF_001.pdf |
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| Mid intervention (month 1.5) and Post intervention (month 3) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Depression, Anxiety, and Stress Scale (DASS-21) | Mean | Standard Deviation | Units on a scale |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post intervention (month 3) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post intervention (month 3) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post intervention (month 3) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post intervention (month 3) |
|
|
|
| Primary | 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. | Posted | Number | Adverse events | Mid intervention (month 1.5) and Post intervention (month 3) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Post intervention (month 3) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 4 |
| 11 |
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| Allergic reaction | Immune system disorders | Systematic Assessment | No relation to intervention, moderate severity, unexpected |
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| GI distress | Gastrointestinal disorders | Systematic Assessment | Unrelated to intervention, moderate severity, and unexpected |
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| High iron levels | General disorders | Systematic Assessment | Unrelated to intervention, moderate severity, unexpected |
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| Physical altercation | Social circumstances | Systematic Assessment | Unrelated to intervention, moderate severity, unexpected |
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