Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Istanbul、トルコ（Türkiye）
- Istanbul Provincial Directorate of Family and Social Services
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：SH+ plus Enhanced Care as Usual (ECAU)
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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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."
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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アクティブコンパレータ：Enhanced Care as Usual (ECAU) only
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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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate (feasibility)
時間枠：Through completion of enrollment and baseline assessment (T0), approximately Month 1
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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.
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Through completion of enrollment and baseline assessment (T0), approximately Month 1
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Session attendance rate (feasibility)
時間枠：Across the 5-week intervention period (Weeks 1 to 5)
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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.
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Across the 5-week intervention period (Weeks 1 to 5)
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Follow-up completion / retention rate (feasibility)
時間枠：From baseline (T0) to 3-month follow-up (T2)
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Proportion of enrolled participants completing the 3-month follow-up (T2) assessment, expressed as a percentage.
A priori threshold is 75% or higher.
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From baseline (T0) to 3-month follow-up (T2)
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Acceptability and participant satisfaction (feasibility)
時間枠：At post-intervention (T1), approximately Week 5-6
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Participant-reported acceptability and satisfaction with the intervention, assessed using the purpose-built SH+ Programme Evaluation Form.
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At post-intervention (T1), approximately Week 5-6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in perceived stress (PSS-10)
時間枠：Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in depressive symptoms (PHQ-9)
時間枠：Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in anxiety symptoms (GAD-7)
時間枠：Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in professional quality of life (ProQOL-IV)
時間枠：Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Professional Quality of Life Scale (ProQOL-IV), a self-report measure assessing compassion satisfaction, burnout, and secondary traumatic stress (compassion fatigue) subscales.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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Change in well-being (WHO-5)
時間枠：Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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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.
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Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraclass correlation coefficient (ICC) for PSS-10
時間枠：Through 3-month follow-up (T2)
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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.
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Through 3-month follow-up (T2)
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Contamination in the control arm
時間枠：Post-intervention (T1) and 3-month follow-up (T2)
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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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Post-intervention (T1) and 3-month follow-up (T2)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SHP-TR-2026-PILOT
- 2026/0026 (その他の識別子：Göztepe Prof. Dr. Süleyman Yalçın City Hospital Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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