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Идёт набор NCT07195019

Women's Wellbeing Study

Без фазы С лечением Distress, Psychological

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Integrative Yoga & Mindful Self-Compassion training, Women's Wellbeing Education.
Кому может быть актуально
Состояния в реестре: Distress, Psychological. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Treatments for Improving Mood in Women

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Integrative Yoga & Mindful Self-Compassion training
    Group Integrative Yoga \& Mindful Self-Compassion training for women with a history of interpersonal violence exposure and distress
  • Поведенческое Women's Wellbeing Education
    Group women's wellbeing education for women with a history of interpersonal violence exposure and distress

Первичные конечные точки

  • Feasibility [Срок оценки: Post intervention (month 3)]
  • Feasibility of Intervention Measure [Срок оценки: Post intervention (month 3)]
  • Intervention Appropriateness Measure [Срок оценки: Post intervention (month 3)]
  • Acceptability of Intervention Measure [Срок оценки: Post intervention (month 3)]
  • The Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: Post intervention (month 3)]
  • Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) [Срок оценки: Post intervention (month 3)]
Вторичные конечные точки (1)
  • Depression Anxiety and Stress Scale (DASS-21) [Срок оценки: Baseline to post intervention (month 3)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Butler Hospital — Providence

Идентификаторы

NCT: NCT07195019 · 1871144-2 · K23AT011917

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗