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

NCT07644949 | Not Yet Recruiting

• 2 other identifiers: SHP-TR-2026-PILOT2026/0026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress, Psychological, Occupational; Stress, Psychological; Psychological Distress; Burnout, Professional

Keywords

Self-Help Plus; SH+; social service workers; universal prevention; cluster randomized trial; pilot study; Acceptance and Commitment Therapy; Turkey; social care workers

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Change in perceived stress (PSS-10)

  Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

• Change in depressive symptoms (PHQ-9)

  Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

• Change in anxiety symptoms (GAD-7)

  Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

• Change in professional quality of life (ProQOL-IV)

  Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

• Change in well-being (WHO-5)

  Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)

Other Outcomes (2)

• Intraclass correlation coefficient (ICC) for PSS-10

  Through 3-month follow-up (T2)

• Contamination in the control arm

  Post-intervention (T1) and 3-month follow-up (T2)

Study Arms (2)

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.

Behavioral: Self-Help Plus (SH+); Behavioral: Enhanced Care as Usual (ECAU)

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).

Behavioral: Enhanced Care as Usual (ECAU)

Interventions

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."

SH+ plus Enhanced Care as Usual (ECAU)

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

Enhanced Care as Usual (ECAU) only; SH+ plus Enhanced Care as Usual (ECAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead
• Istanbul Provincial Directorate of Family and Social Services: collaborator

Study Sites (1)

Istanbul Provincial Directorate of Family and Social Services

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress, Psychological; Burnout, Professional

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases; Burnout, Psychological

Central Study Contacts

Yunus Oguz, MD

CONTACT

+90 542 205 65 43; yunusoguz@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind: outcome assessment is by self-report online forms and the data analyst is blinded to allocation. Participants and facilitators are not blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster-randomized: allocation is at the institution (cluster) level, stratified by service type, with two clusters per arm (1:1)

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

TU (1)