Stress, Psychological, OccupationalNCT07644949
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
A study testing Self-Help Plus (SH+) and Enhanced Care as Usual (ECAU) in people with Stress, Psychological, Occupational and Stress, Psychological, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Occupational, Stress, Psychological, Psychological Distress
- What is being tested?
- Self-Help Plus (SH+) and Enhanced Care as Usual (ECAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Directorate of Family and Social Services
Istanbul
About this study
Official title: Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stress, Psychological, Occupational, Stress, Psychological, Psychological Distress, Burnout, Professional
- Being tested
- Self-Help Plus (SH+), Enhanced Care as Usual (ECAU)
- Keywords
- Self-Help Plus, SH+, social service workers, universal prevention, cluster randomized trial, pilot study, Acceptance and Commitment Therapy, Turkey, social care workers
- Medical subject headings
- Stress, Psychological, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help Plus (SH+)Behavioural
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."
Enhanced Care as Usual (ECAU)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Enhanced Care as Usual (ECAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At post-intervention (T1), approximately Week 5-6
Secondary outcomes (5)
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.
Measured: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), post-intervention (T1), and 3-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start23 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, Psychological, OccupationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized: allocation is at the institution (cluster) level, stratified by service type, with two clusters per arm (1:1)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Provincial Directorate of Family and Social Services
- Responsible party
- Principal investigator, Mustafa Cakır, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644949
- Sponsor's protocol ID
- SHP-TR-2026-PILOT
- Other IDs
- 2026/0026
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07644949
- Acronym / sponsor ID
- SHP-TR-2026-PILOT
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul Provincial Directorate of Family and Social Services
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized: allocation is at the institution (cluster) level, stratified by service type, with two clusters per arm (1:1)
| Arm | Type | Receives |
|---|---|---|
| SH+ plus Enhanced Care as Usual (ECAU) | Experimental | Behavioral: Self-Help Plus (SH+), Behavioral: 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. |
| Enhanced Care as Usual (ECAU) only | Active comparator | Behavioral: Enhanced Care as Usual (ECAU)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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." | Behavioural | SH+ plus Enhanced Care as Usual (ECAU) |
| 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 | Behavioural | Enhanced Care as Usual (ECAU) only, SH+ plus Enhanced Care as Usual (ECAU) |
Primary outcome
Recruitment rate (feasibility)
Time frame: Through completion of enrollment and baseline assessment (T0), approximately Month 1
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)
Time frame: Across the 5-week intervention period (Weeks 1 to 5)
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)
Time frame: From baseline (T0) to 3-month follow-up (T2)
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)
Time frame: At post-intervention (T1), approximately Week 5-6
Participant-reported acceptability and satisfaction with the intervention, assessed using the purpose-built SH+ Programme Evaluation Form.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Stress, Psychological, Occupational
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
Active, not recruiting
A Pilot Study of RISE for Nurse Managers Retreat
Burnout, Secondary Traumatic Stress
Enrolling by invitationObservational study
Floatation Experience in Nurses and Physicians
Burnout, Professional, Negative Affect
Not yet recruitingObservational study
Monitoring Occupational Dental Stress Using Apple Watch
Occupational Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Help Plus (SH+) and Enhanced Care as Usual (ECAU) in people with Stress, Psychological, Occupational and Stress, Psychological, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (feasibility) (time frame: Through completion of enrollment and baseline assessment (T0), approximately Month 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.