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| ID | Type | Description | Link |
|---|---|---|---|
| 2026/0026 | Other Identifier | Göztepe Prof. Dr. Süleyman Yalçın City Hospital Clinical Research Ethics Committee |
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| Name | Class |
|---|---|
| Istanbul Provincial Directorate of Family and Social Services | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SH+ plus Enhanced Care as Usual (ECAU) | Experimental | 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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| Enhanced Care as Usual (ECAU) only | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Help Plus (SH+) | Behavioral | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through completion of enrollment and baseline assessment (T0), approximately Month 1 |
| 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. | Across the 5-week intervention period (Weeks 1 to 5) |
| 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. | From baseline (T0) to 3-month follow-up (T2) |
| Acceptability and participant satisfaction (feasibility) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0), post-intervention (T1), and 3-month follow-up (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through 3-month follow-up (T2) |
| Contamination in the control arm |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunus Oguz, MD | Contact | +90 542 205 65 43 | yunusoguz@windowslive.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Provincial Directorate of Family and Social Services | Istanbul | Turkey (Türkiye) |
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.
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Cluster-randomized: allocation is at the institution (cluster) level, stratified by service type, with two clusters per arm (1:1)
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Single-blind: outcome assessment is by self-report online forms and the data analyst is blinded to allocation. Participants and facilitators are not blinded
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| Enhanced Care as Usual (ECAU) | Behavioral | 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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| 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. |
| Baseline (T0), post-intervention (T1), and 3-month follow-up (T2) |
| 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. | Baseline (T0), post-intervention (T1), and 3-month follow-up (T2) |
| 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. | Baseline (T0), post-intervention (T1), and 3-month follow-up (T2) |
| Change in well-being (WHO-5) | 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) |
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) |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D002055 | Burnout, Professional |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
| D000077062 | Burnout, Psychological |
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