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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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Rhode Island
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Providence, Rhode Island, Forente stater, 02906
- Rekruttering
- Butler Hospital
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Ta kontakt med:
- Research Coordinator
- Telefonnummer: 401-455-6200, ext. 21070
- E-post: i-ymsc.study@butler.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion 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
Exclusion Criteria:
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Inability to be physically active, determined by a score >1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation
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Planned surgery in next 6 months, as this would interfere with study participation
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Pregnancy, as yoga should be modified for pregnancy
Women who meet criteria for the following:
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Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
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Lifetime history of psychotic disorders (DIAMOND)
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Current probable severe substance use disorder (DIAMOND)
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Current diagnosis of anorexia nervosa or history in past year (DIAMOND)
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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
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Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks
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Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes
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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
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Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Integrative Yoga and Mindful Self-Compassion (I-YMSC) training
12 weeks of I-YMSC training |
Group Integrative Yoga & Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress |
|
Aktiv komparator: Women's Wellbeing Education (WWE)
12 weeks of group WWE |
Group women's wellbeing education for women with a history of interpersonal violence exposure and distress |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility
Tidsramme: Post intervention (month 3)
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Feasibility assessed based on number of participants who remained in the intervention (retention). |
Post intervention (month 3)
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Feasibility of Intervention Measure
Tidsramme: Post intervention (month 3)
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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. |
Post intervention (month 3)
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Intervention Appropriateness Measure
Tidsramme: Post intervention (month 3)
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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. |
Post intervention (month 3)
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Acceptability of Intervention Measure
Tidsramme: Post intervention (month 3)
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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. |
Post intervention (month 3)
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The Client Satisfaction Questionnaire (CSQ-8)
Tidsramme: Post intervention (month 3)
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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)
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Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
Tidsramme: Post intervention (month 3)
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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. |
Post intervention (month 3)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Depression Anxiety and Stress Scale (DASS-21)
Tidsramme: Baseline to post intervention (month 3)
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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. |
Baseline to post intervention (month 3)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1871144-2
- K23AT011917 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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