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Идёт набор NCT06907654

Couples' Affect in Relationships Study

Без фазы С лечением Depression Disorders

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: well-being app, List of well-being resources.
Кому может быть актуально
Состояния в реестре: Depression Disorders. Базовые параметры: от 18 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is: * Does gaining knowledge about well-being positively impact individuals and their romantic relationships? Participants will complete online surveys about their thoughts and feelings.

Подробное описание

This study will deliver a meditation-based mobile intervention (The Healthy Minds Program) to one member of a long-term romantic couple and will assess for relationship satisfaction/distress, well-being, and mindfulness in both the primary participant and their partner. The control group will receive a list of well-being-based psychoeducation resources.

Вмешательства

  • Устройство well-being app
    The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
  • Поведенческое List of well-being resources
    Participants will be given a list of resources that promote well-being.

Первичные конечные точки

  • Change in Primary Participant-Rated Couples Satisfaction Index (CSI-16) [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person PHQ-9 Rating of Primary Participant [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
Вторичные конечные точки (12)
  • Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S) [Срок оценки: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Primary Participant-Rated PHQ-9 [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person PHQ-9 Rating of Primary Participant [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Relationship Longevity [Срок оценки: Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Partner Participant-Rated PHQ-9 [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Problematic and Risky Internet Use Screening Scale (PRIUSS 3) [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Partner Participant-Rated Couples Satisfaction Index (CSI-16) [Срок оценки: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person Sussex-Oxford Compassion for the Self Scale (SOCS-S) [Срок оценки: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Relationship Attribution Measure [Срок оценки: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Partner Acceptance Scale [Срок оценки: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Observed Mindfulness Measure [Срок оценки: Baseline, Week 4, 3-Month Follow-Up]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Be either married, living together, OR in a dating relationship for at least 12 months
  • Proficiency in English
  • US citizen or permanent resident
  • If non-monogamous, must be able to enroll in the study with a primary partner with whom they spend the majority of their time.
  • Use of a smartphone (primary participant only)
  • Phone able to receive SMS text messages
  • Depression symptoms (≥ 5 on PHQ-9; primary participant only)

Критерии исключения

  • Severe physical or sexual relationship aggression during the past 6 months (any item endorsement on 5-item severe IPV screener)
  • Endorsement of active suicidality
  • History of psychosis or mania
  • Prior use of the Healthy Minds Program app
  • Prior significant experience with meditation
  • Severe hearing impairment that would interfere with the use of an audio-based intervention (primary participant only)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Wisconsin - Madison — Madison

Идентификаторы

NCT: NCT06907654 · 2025-0357 · A171600 · EDUC/COUNSELING PSYCH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗