Stress, Psychological, OccupationalStress, PsychologicalPsychological DistressBurnout, Professional
Investigational drug(s) / intervention(s)
Self-Help Plus (SH+)Enhanced Care as Usual (ECAU)
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."
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
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Recruitment rate (feasibility) — 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.
Session attendance rate (feasibility) — 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.
Follow-up completion / retention rate (feasibility) — 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.
Acceptability and participant satisfaction (feasibility) — 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.
Trial sites (1)
Facility
City
Region
Status
Istanbul Provincial Directorate of Family and Social Services
Istanbul
Turkey (Türkiye)
More Istanbul Medeniyet University trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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