Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
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: Self-Help Plus (SH+), Enhanced Care as Usual (ECAU).
- Кому может быть актуально
- Состояния в реестре: Stress, Psychological, Occupational, Stress, Psychological, Psychological Distress, Burnout, Professional. 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
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial
Обзор
This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.
Подробное описание
Social service workers are chronically exposed to traumatic content and occupational stress, placing them at elevated risk for psychological distress and secondary traumatic stress. A universal-prevention approach is adopted: no individual stress threshold is required for inclusion, as the occupational context itself serves as a high-risk filter.
Randomization is performed at the institution (cluster) level rather than the individual level to prevent contamination, accommodate the group format of the intervention, and reflect logistical realities of the institutions. Two clusters are allocated to the intervention arm and two to the control arm (1:1), stratified by service type. The allocation list is generated by a researcher independent of the field team, and assignment is revealed only after baseline (T0) assessment is complete. The trial is single-blind: participants and facilitators cannot be blinded, but outcome assessment is self-report via online forms (structural assessor masking) and the data analyst is blinded to group allocation (groups coded A/B until analysis is complete).
The SH+ intervention is a low-intensity, guided self-help program based on Acceptance and Commitment Therapy, delivered by trained non-specialist facilitators in a group format across five weekly sessions of approximately two hours each. It uses a pre-recorded audio course complemented by the illustrated self-help book "Doing What Matters in Times of Stress"; participants receive the book and weekly audio exercises for between-session practice. The ECAU control comprises continued access to existing institutional support and routine services plus a comprehensive psychoeducational information pack (stress-coping strategies, recognition of stress symptoms, and pathways to mental health and psychosocial support services in Istanbul). After the 3-month follow-up (T2), control-arm participants are offered the opportunity to attend SH+ sessions.
Assessments are collected at baseline (T0, pre-randomization), post-intervention (T1), and 3-month follow-up (T2) via self-report online forms. Feasibility progression thresholds are pre-specified: recruitment rate ≥70%, session attendance ≥70% (attending at least 3 of 5 sessions), and follow-up completion ≥75%. Preliminary effectiveness is analyzed using design-effect-adjusted methods or linear mixed models accounting for clustering; effect sizes (Cohen's d) with 95% confidence intervals are reported. The intraclass correlation coefficient (ICC) for the primary clinical outcome (PSS-10) is estimated to inform sample-size planning for a future full-scale cluster RCT.
Вмешательства
- Поведенческое Self-Help Plus (SH+)
WHO Self-Help Plus: a low-intensity, ACT-based guided self-help program delivered by trained non-specialist facilitators in a group format over five weekly sessions (approximately 2 hours each), using a pre-recorded audio course and the illustrated self-help book "Doing What Matters in Times of Stress." - Поведенческое Enhanced Care as Usual (ECAU)
Continued access to existing institutional support and routine services plus a comprehensive psychoeducational information pack on stress-coping strategies, recognition of stress symptoms, and referral pathways to mental health and psychosocial support services
Первичные конечные точки
- Recruitment rate (feasibility) [Срок оценки: Through completion of enrollment and baseline assessment (T0), approximately Month 1]
- Session attendance rate (feasibility) [Срок оценки: Across the 5-week intervention period (Weeks 1 to 5)]
- Follow-up completion / retention rate (feasibility) [Срок оценки: From baseline (T0) to 3-month follow-up (T2)]
- Acceptability and participant satisfaction (feasibility) [Срок оценки: At post-intervention (T1), approximately Week 5-6]
Вторичные конечные точки (5)
- Change in perceived stress (PSS-10) [Срок оценки: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
- Change in depressive symptoms (PHQ-9) [Срок оценки: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
- Change in anxiety symptoms (GAD-7) [Срок оценки: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
- Change in professional quality of life (ProQOL-IV) [Срок оценки: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
- Change in well-being (WHO-5) [Срок оценки: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
Критерии участия
Критерии включения
- Currently employed (permanent, contracted, or temporary staff) at an institution under the Istanbul Provincial Directorate of Family and Social Services
- Able to read and write in Turkish
- Willing to participate voluntarily
- Provides written informed consent
Критерии исключения
- Imminent suicide risk, screened at baseline (T0) via PHQ-9 item 9; participants scoring 2 or higher are not enrolled and are immediately referred to a mental health professional
- Active psychosis, severe substance use disorder, or severe intellectual disability
- An acute medical condition that would preclude participation
- Planned extended leave (e.g., maternity or unpaid leave) during the study period
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
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Turkey (Türkiye) · 1 центр
- Istanbul Provincial Directorate of Family and Social Services — Istanbul
Идентификаторы
NCT: NCT07644949 · SHP-TR-2026-PILOT · 2026/0026