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Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT

9 czerwca 2026 zaktualizowane przez: Mustafa Cakır, Istanbul Medeniyet University

Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Istanbul, Turcja (Türkiye)
        • Istanbul Provincial Directorate of Family and Social Services

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: SH+ plus Enhanced Care as Usual (ECAU)
Participants in clusters allocated to this arm receive the Self-Help Plus (SH+) group program (five weekly approximately 2-hour sessions) in addition to Enhanced Care as Usual.
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."
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
Aktywny komparator: Enhanced Care as Usual (ECAU) only
Participants in clusters allocated to this arm receive Enhanced Care as Usual only (psychoeducational information pack plus continued access to existing services). SH+ is offered after the 3-month follow-up (waitlist).
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment rate (feasibility)
Ramy czasowe: Through completion of enrollment and baseline assessment (T0), approximately Month 1
Proportion of eligible staff who provide consent and enroll, calculated as the number enrolled divided by the number eligible, expressed as a percentage. A priori progression threshold is set at 70% or higher.
Through completion of enrollment and baseline assessment (T0), approximately Month 1
Session attendance rate (feasibility)
Ramy czasowe: Across the 5-week intervention period (Weeks 1 to 5)
Proportion of intervention-arm participants attending at least 3 of the 5 SH+ sessions, expressed as a percentage. A priori threshold is 70% or higher.
Across the 5-week intervention period (Weeks 1 to 5)
Follow-up completion / retention rate (feasibility)
Ramy czasowe: From baseline (T0) to 3-month follow-up (T2)
Proportion of enrolled participants completing the 3-month follow-up (T2) assessment, expressed as a percentage. A priori threshold is 75% or higher.
From baseline (T0) to 3-month follow-up (T2)
Acceptability and participant satisfaction (feasibility)
Ramy czasowe: At post-intervention (T1), approximately Week 5-6
Participant-reported acceptability and satisfaction with the intervention, assessed using the purpose-built SH+ Programme Evaluation Form.
At post-intervention (T1), approximately Week 5-6

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in perceived stress (PSS-10)
Ramy czasowe: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Perceived Stress Scale (PSS-10), a 10-item self-report measure with a total score ranging from 0 to 40; higher scores indicate greater perceived stress. Between-group comparison of change from baseline.
Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Change in depressive symptoms (PHQ-9)
Ramy czasowe: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure with a total score ranging from 0 to 27; higher scores indicate more severe depressive symptoms.
Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Change in anxiety symptoms (GAD-7)
Ramy czasowe: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure with a total score ranging from 0 to 21; higher scores indicate more severe anxiety symptoms.
Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Change in professional quality of life (ProQOL-IV)
Ramy czasowe: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Professional Quality of Life Scale (ProQOL-IV), a self-report measure assessing compassion satisfaction, burnout, and secondary traumatic stress (compassion fatigue) subscales.
Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Change in well-being (WHO-5)
Ramy czasowe: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
WHO-5 Well-Being Index, a 5-item self-report measure; the raw score is transformed to a 0 to 100 scale, with higher scores indicating better well-being.
Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Intraclass correlation coefficient (ICC) for PSS-10
Ramy czasowe: Through 3-month follow-up (T2)
Intraclass correlation coefficient for the primary clinical outcome (PSS-10), estimated to inform the design effect and sample-size calculations for a future full-scale cluster randomized controlled trial.
Through 3-month follow-up (T2)
Contamination in the control arm
Ramy czasowe: Post-intervention (T1) and 3-month follow-up (T2)
Self-reported exposure of control-arm participants to SH+ materials, sessions, or content during the study period, reported descriptively to assess the feasibility of cluster randomization.
Post-intervention (T1) and 3-month follow-up (T2)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 października 2026

Ukończenie studiów (Szacowany)

1 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SHP-TR-2026-PILOT
  • 2026/0026 (Inny identyfikator: Göztepe Prof. Dr. Süleyman Yalçın City Hospital Clinical Research Ethics Committee)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

As this is a pilot feasibility trial, a data-sharing plan has not yet been finalized. Decisions regarding sharing of de-identified individual participant data will be made in line with KVKK (Turkish data protection law) requirements and institutional policy, and updated in this record accordingly.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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Badania kliniczne na Wypalenie, profesjonalista

Badania kliniczne na Self-Help Plus (SH+)

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