Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Istanbul, Turquia (Türkiye)
- Istanbul Provincial Directorate of Family and Social Services
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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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
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Comparador Ativo: 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).
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Recruitment rate (feasibility)
Prazo: Through completion of enrollment and baseline assessment (T0), approximately Month 1
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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.
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Through completion of enrollment and baseline assessment (T0), approximately Month 1
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Session attendance rate (feasibility)
Prazo: Across the 5-week intervention period (Weeks 1 to 5)
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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.
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Across the 5-week intervention period (Weeks 1 to 5)
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Follow-up completion / retention rate (feasibility)
Prazo: From baseline (T0) to 3-month follow-up (T2)
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Proportion of enrolled participants completing the 3-month follow-up (T2) assessment, expressed as a percentage.
A priori threshold is 75% or higher.
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From baseline (T0) to 3-month follow-up (T2)
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Acceptability and participant satisfaction (feasibility)
Prazo: At post-intervention (T1), approximately Week 5-6
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Participant-reported acceptability and satisfaction with the intervention, assessed using the purpose-built SH+ Programme Evaluation Form.
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At post-intervention (T1), approximately Week 5-6
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in perceived stress (PSS-10)
Prazo: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in depressive symptoms (PHQ-9)
Prazo: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in anxiety symptoms (GAD-7)
Prazo: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in professional quality of life (ProQOL-IV)
Prazo: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Professional Quality of Life Scale (ProQOL-IV), a self-report measure assessing compassion satisfaction, burnout, and secondary traumatic stress (compassion fatigue) subscales.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in well-being (WHO-5)
Prazo: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intraclass correlation coefficient (ICC) for PSS-10
Prazo: Through 3-month follow-up (T2)
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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.
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Through 3-month follow-up (T2)
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Contamination in the control arm
Prazo: Post-intervention (T1) and 3-month follow-up (T2)
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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.
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Post-intervention (T1) and 3-month follow-up (T2)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SHP-TR-2026-PILOT
- 2026/0026 (Outro identificador: Göztepe Prof. Dr. Süleyman Yalçın City Hospital Clinical Research Ethics Committee)
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