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.
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
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
Parallel
Self-Help Plus (SH+)
BehavioralWHO 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)
BehavioralContinued 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
Recruitment rate (feasibility)
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)
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)
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)
Participant-reported acceptability and satisfaction with the intervention, assessed using the purpose-built SH+ Programme Evaluation Form.
Change in perceived stress (PSS-10)
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.
Change in depressive symptoms (PHQ-9)
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.
Change in anxiety symptoms (GAD-7)
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.
Change in professional quality of life (ProQOL-IV)
Professional Quality of Life Scale (ProQOL-IV), a self-report measure assessing compassion satisfaction, burnout, and secondary traumatic stress (compassion fatigue) subscales.
Intraclass correlation coefficient (ICC) for PSS-10
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.
Contamination in the control arm
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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Istanbul Medeniyet University
Lead sponsor
Istanbul Provincial Directorate of Family and Social Services
Collaborator
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