Menu
Not yet recruiting NCT07644949

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

No phase Interventional Stress, Psychological, Occupational Stress, Psychological Psychological Distress Burnout, Professional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Help Plus (SH+), Enhanced Care as Usual (ECAU).
Who it may be relevant to
Registry conditions: Stress, Psychological, Occupational, Stress, Psychological, Psychological Distress, Burnout, Professional. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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."
  • Behavioral 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

Primary outcome measures

  • Recruitment rate (feasibility) [Time frame: Through completion of enrollment and baseline assessment (T0), approximately Month 1]
  • Session attendance rate (feasibility) [Time frame: Across the 5-week intervention period (Weeks 1 to 5)]
  • Follow-up completion / retention rate (feasibility) [Time frame: From baseline (T0) to 3-month follow-up (T2)]
  • Acceptability and participant satisfaction (feasibility) [Time frame: At post-intervention (T1), approximately Week 5-6]
Secondary outcome measures (5)
  • Change in perceived stress (PSS-10) [Time frame: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
  • Change in depressive symptoms (PHQ-9) [Time frame: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
  • Change in anxiety symptoms (GAD-7) [Time frame: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
  • Change in professional quality of life (ProQOL-IV) [Time frame: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]
  • Change in well-being (WHO-5) [Time frame: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Provincial Directorate of Family and Social Services — Istanbul

Identifiers

NCT: NCT07644949 · SHP-TR-2026-PILOT · 2026/0026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗