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Идёт набор NCT07391072

Effectiveness of a Waitlist App "Stappvoorstap" During Mental Healthcare Waiting Times

Без фазы С лечением Psychological Stress Coping Ability Mental Health Quality of Life

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: Stappvoorstap: mobile self-management waitlist intervention.
Кому может быть актуально
Состояния в реестре: Psychological Stress, Coping Ability, Mental Health, Quality of Life. 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
Нидерланды
Следующий шаг
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Официальное название

Bridging the Gap: A Multiple Baseline Design Study on the Effectiveness of a Mobile-based Stress Management Intervention in Adults on Waiting Lists for Mental Healthcare

Обзор

This study evaluates the effectiveness of Stappvoorstap, a mobile self-management application designed for adults on mental health waiting lists in the Netherlands. The app helps users monitor daily stress levels, recognize personal stress patterns, and provides coping strategies, relaxation exercises, and supportive resources. Using a multiple baseline single-case experimental design, participants use the app for 4 weeks while completing weekly questionnaires measuring perceived stress, coping self-efficacy, and quality of life. The study aims to determine whether the app can reduce stress and improve wellbeing during the waiting period before mental healthcare treatment begins.

Подробное описание

Prolonged waiting times for mental healthcare pose significant challenges, with nearly 100,000 people on waiting lists in the Netherlands as of December 2023. During this period, symptoms can worsen, daily functioning may decline, and quality of life decreases. Stappvoorstap was developed in co-creation with waitlist clients and experts-by-experience to address this gap. The app is based on stress-signaling plans used in Dutch mental healthcare and functions as an ecological momentary intervention. It measures perceived stress 2-4 times daily, creates visual overviews of stress patterns, and provides real-time coping suggestions, mindfulness exercises, informational articles, and personal stories from other clients. This study uses a nonconcurrent multiple baseline design with A-B-A design. Participants are randomly assigned to 3, 4, or 5-week baseline phases, followed by 4 weeks of app use, and 3 weeks of follow-up. Weekly assessments include the Perceived Stress Scale (PSS-10), Coping Self-Efficacy Scale (CSES-13), and WHOQOL-BREF. Both group-level and individual case analyses will be conducted using mixed-effects modeling and Tau-(BC) effect size measures.

Participants are recruited from mental health waiting lists across the Netherlands. As this is a mobile app-based intervention, participation is location-independent and takes place remotely.

Вмешательства

  • Поведенческое Stappvoorstap: mobile self-management waitlist intervention
    Stappvoorstap is a free mobile self-management application developed in co-creation with mental health waitlist clients. The app measures daily stress levels 2-4 times per day through short questionnaires, creates visual overviews of personal stress patterns on daily and weekly scales, provides real-time coping suggestions, offers mindfulness and relaxation exercises (breathing exercises, meditation, nature sounds, calming music), and includes informational articles and personal experience stori

Первичные конечные точки

  • Change in Perceived Stress [Срок оценки: Weekly measurements for 10-12 weeks (depending on group assignment)]
Вторичные конечные точки (2)
  • Change in Coping Self-Efficacy [Срок оценки: Weekly measurements for 10-12 weeks (depending on group assignment)]
  • Change in Quality of Life [Срок оценки: Weekly measurements for 10-12 weeks (depending on group assignment)]

Критерии участия

Критерии включения

  • Currently on a waiting list at a mental health organization in the Netherlands.
  • Aged 18 years or older
  • Owns a smartphone and has the ability to operate it
  • Sufficient proficiency in Dutch or English language (at least B1 level)

Критерии исключения

  • Currently enrolled in another medical-scientific research study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Нидерланды · 1 центр
  • GGZ Centraal — Almere Stad

Идентификаторы

NCT: NCT07391072 · Stappvoorstap_N24.084 · KPO-79

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗