Distress, PsychologicalRESTORENCT06698471
Relief From Stress Via Social Protection in Senegal
A study testing Community worker training and Referral to Health System in people with Distress, Psychological and Depression - Major Depressive Disorder, run by Georgetown University at 1 site in Senegal.
Trial summary
Despite the growing prevalence of mental health disorders in low- and middle-income countries, significant barriers to seeking and accessing mental health services persist. Within lower income populations, the prevalence of mental health disorders and barriers to addressing them are worsened by poverty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress, Psychological, Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
- What is being tested?
- Community worker training and Referral to Health System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteSenegal
- Study dates
- 24 Feb 2025to Oct 2025
- 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
- Community Worker facilitators of the intervention:
- Patients: Enrolled in the World Bank Social Protection Programme
Who cannot join
- Community Worker facilitators of the intervention
- Patients: Persons with a severe mental disorder or suicidality
Trial locations and contacts
1 site in 1 country.
Senegal1 site
Centre de Recherche Pour le Développement Economique et Social (CRDES)
Dakar
About this study
Official title: Relief From Stress Via Social Protection in Senegal (RESTORE): Study Protocol for a Pilot Feasibility Cluster-randomized Control Trial of Self-Help Plus (SH+) in Senegal.
Despite the growing prevalence of mental health disorders in low- and middle-income countries, significant barriers to seeking and accessing mental health services persist. Within lower income populations, the prevalence of mental health disorders and barriers to addressing them are worsened by poverty. Self-Help Plus is a group-based stress management program delivered using a task-sharing model and designed to circumvent barriers to addressing mental health concerns. Cultural adaptations of Self-Help Plus have been implemented in several countries and are considered cost-effective. However, to date, Self-Help Plus has not been adapted for Senegalese populations. The study detailed in this manuscript aims to assess the feasibility and acceptability of Self-Help Plus in lower income populations in Senegal.
The study is a pilot feasibility cluster-randomized control trial of Self-Help Plus in four Senegalese communities. Clusters of social protection program beneficiaries will be randomly selected to receive five sessions of Self-Help Plus. The intervention will be delivered in groups of up to 30 beneficiaries and co-facilitated by two community workers. A combination of quantitative and qualitative research methods will be used to assess the feasibility and acceptability of both the Self-Help Plus intervention and randomized control trial procedures. The study sample will include social protection program beneficiaries in the treatment and control groups, Self-Help Plus facilitators, project staff supporting the training of facilitators, and the intervention supervisor.
The findings of this study will be used to inform the potential integration of Self-Help Plus and/or similar mental health interventions into the national social protection program in Senegal.
Read the detailed description
The primary objective of the pilot feasibility cluster-randomized controlled trial is to assess the feasibility and acceptability of both the Self-Help Plus intervention and trial procedures through the collection of quantitative and qualitative data. The study will include two trial arms: (1) a control treatment-as-usual arm and (2) an intervention arm that will receive the adapted Self Help Plus intervention. The findings of the research detailed in this protocol may be used to inform the design of a potential larger randomized control trial powered to assess the effectiveness of Self-Help Plus in Senegalese populations. Additional secondary objectives of the pilot feasibility study are listed below.
- Assess feasibility of cluster randomization procedure to limit biases and risk of contamination;
- Determine recruitment and retention rates for Self-Help Plus sessions;
- Evaluate the feasibility and acceptability of intervention delivery by Self-Help Plus trained non-specialists;
- Assess the safety of an abbreviated training curriculum (during training, intervention delivery, and supervision);
- Assess feasibility and acceptability of outcome measures;
- Assess ethics and safety of trial procedures using the adverse event protocol;
- Conditions
- Distress, Psychological, Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
- Being tested
- Community worker training, Referral to Health System
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community worker trainingOther
Training community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy
Referral to Health SystemOther
Referral to Health System of Senegal
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Treatment as usual from Health System in Senegal Receives: Other: Referral to Health System |
| Relief from Stress via Social Protection in Senegal | Experimental | Training community workers in Self Help Plus intervention Receives: Other: Community worker training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Of those who were offered the intervention, at least 25% attended one or more sessions.
Measured: From enrollment to the end of treatment at 5 weeks
Retention
At least 50% of the ever-attended beneficiaries attended at least any 4 intervention sessions
Measured: From enrollment to the end of treatment at 5 weeks
Fidelity
Fidelity to intervention elements at the level of 75% or greater according to the mean fidelity checklist for intervention elements across all sessions. Number of feasibility domains: n=15; higher is better, scored on 0-100%
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (21)
General Health Questionnaire-12
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
Measured: Prior to initiation of treatment
General Health Questionnaire-12
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
Measured: 2 months following initiation of treatment
General Health Questionnaire-12
Brief psychological well-being scale. Score range: 0-36; Higher score indicates worse psychological well-being
Measured: 5 months following initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Measured: Prior to initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Measured: 2 months following initiation of treatment
Patient Health Questionnaire-9
Brief depression screening instrument. Score range: 0-27; Higher score indicates worse depressive symptoms
Measured: 5 months following initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Measured: Prior to initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Measured: 2 months following initiation of treatment
Generalized Anxiety Disorder-7
Brief anxiety screening instrument. Score range: 0-21; Higher score indicates worse anxiety symptoms
Measured: 5 months following initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Measured: Prior to initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Measured: 2 months following initiation of treatment
Brief Resilience Scale
Brief resilience measure. Score range: 0-30; Higher score indicates better resilience
Measured: 5 months following initiation of treatment
Acceptance and Action Questionnaire
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
Measured: Prior to initiation of treatment
Acceptance and Action Questionnaire
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
Measured: 2 months following initiation of treatment
Acceptance and Action Questionnaire
Brief scale of psychological flexibility. Score range: 0-35; Higher score indicates worse psychological flexibility
Measured: 5 months following initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Measured: Prior to initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Measured: 2 months following initiation of treatment
Self Efficacy
Brief scale of self efficacy. Score range: 0-24; Higher score indicates better self efficacy
Measured: 5 months following initiation of treatment
Locus of control questionnaire
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
Measured: Prior to initiation of treatment
Locus of control questionnaire
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
Measured: 2 months following initiation of treatment
Locus of control questionnaire
Brief scale measuring locus of control. Score range: 0-20; Higher score indicates better locus of control
Measured: 5 months following initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start24 Feb 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank, Centre de Recherche Pour le Développement Economique et Social (CRDES)
- Responsible party
- Sponsor
- Investigators
- Syed S Wahid, Doctor of Public Health, Principal investigator, Georgetown UniversityAnne Hilger, PhD, Principal investigator, World Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698471
- Sponsor's protocol ID
- IRB#2575
- Acronym
- RESTORE
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relief From Stress Via Social Protection in Senegal (RESTORE): Study Protocol for a Pilot Feasibility Cluster-randomized Control Trial of Self-Help Plus (SH+) in Senegal.
- ClinicalTrials.gov ID
- NCT06698471
- Acronym / sponsor ID
- RESTORE / IRB#2575
- Conditions
- Distress, Psychological, Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- World Bank, Centre de Recherche Pour le Développement Economique et Social (CRDES)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 21 Nov 2024 (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.
Despite the growing prevalence of mental health disorders in low- and middle-income countries, significant barriers to seeking and accessing mental health services persist. Within lower income populations, the prevalence of mental health disorders and barriers to addressing them are worsened by poverty. Self-Help Plus is a group-based stress management program delivered using a task-sharing model and designed to circumvent barriers to addressing mental health concerns. Cultural adaptations of Self-Help Plus have been implemented in several countries and are considered cost-effective. However, to date, Self-Help Plus has not been adapted for Senegalese populations. The study detailed in this manuscript aims to assess the feasibility and acceptability of Self-Help Plus in lower income populations in Senegal.
The study is a pilot feasibility cluster-randomized control trial of Self-Help Plus in four Senegalese communities. Clusters of social protection program beneficiaries will be randomly selected to receive five sessions of Self-Help Plus. The intervention will be delivered in groups of up to 30 beneficiaries and co-facilitated by two community workers. A combination of quantitative and qualitative research methods will be used to assess the feasibility and acceptability of both the Self-Help Plus intervention and randomized control trial procedures. The study sample will include social protection program beneficiaries in the treatment and control groups, Self-Help Plus facilitators, project staff supporting the training of facilitators, and the intervention supervisor.
The findings of this study will be used to inform the potential integration of Self-Help Plus and/or similar mental health interventions into the national social protection program in Senegal.
Detailed description
The primary objective of the pilot feasibility cluster-randomized controlled trial is to assess the feasibility and acceptability of both the Self-Help Plus intervention and trial procedures through the collection of quantitative and qualitative data. The study will include two trial arms: (1) a control treatment-as-usual arm and (2) an intervention arm that will receive the adapted Self Help Plus intervention. The findings of the research detailed in this protocol may be used to inform the design of a potential larger randomized control trial powered to assess the effectiveness of Self-Help Plus in Senegalese populations. Additional secondary objectives of the pilot feasibility study are listed below.
- Assess feasibility of cluster randomization procedure to limit biases and risk of contamination;
- Determine recruitment and retention rates for Self-Help Plus sessions;
- Evaluate the feasibility and acceptability of intervention delivery by Self-Help Plus trained non-specialists;
- Assess the safety of an abbreviated training curriculum (during training, intervention delivery, and supervision);
- Assess feasibility and acceptability of outcome measures;
- Assess ethics and safety of trial procedures using the adverse event protocol;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Referral to Health SystemTreatment as usual from Health System in Senegal |
| Relief from Stress via Social Protection in Senegal | Experimental | Other: Community worker trainingTraining community workers in Self Help Plus intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community Worker facilitators of the intervention:
- Patients: Enrolled in the World Bank Social Protection Programme
Key exclusion criteria (2 listed)
- Community Worker facilitators of the intervention
- Patients: Persons with a severe mental disorder or suicidality
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 |
|---|---|---|
| Community worker trainingTraining community workers in Self Help Plus intervention, a 5 session self-help intervention based on Acceptance and Commitment Therapy | Other | Relief from Stress via Social Protection in Senegal |
| Referral to Health SystemReferral to Health System of Senegal | Other | Treatment as usual |
Primary outcome
Engagement
Time frame: From enrollment to the end of treatment at 5 weeks
Of those who were offered the intervention, at least 25% attended one or more sessions.
Retention
Time frame: From enrollment to the end of treatment at 5 weeks
At least 50% of the ever-attended beneficiaries attended at least any 4 intervention sessions
Fidelity
Time frame: From enrollment to the end of treatment at 5 weeks
Fidelity to intervention elements at the level of 75% or greater according to the mean fidelity checklist for intervention elements across all sessions. Number of feasibility domains: n=15; higher is better, scored on 0-100%
21 secondary outcomes
General Health Questionnaire-12
Time frame: Prior to initiation of treatment
General Health Questionnaire-12
Time frame: 2 months following initiation of treatment
General Health Questionnaire-12
Time frame: 5 months following initiation of treatment
Patient Health Questionnaire-9
Time frame: Prior to initiation of treatment
Patient Health Questionnaire-9
Time frame: 2 months following initiation of treatment
Patient Health Questionnaire-9
Time frame: 5 months following initiation of treatment
Generalized Anxiety Disorder-7
Time frame: Prior to initiation of treatment
Generalized Anxiety Disorder-7
Time frame: 2 months following initiation of treatment
Generalized Anxiety Disorder-7
Time frame: 5 months following initiation of treatment
Brief Resilience Scale
Time frame: Prior to initiation of treatment
Brief Resilience Scale
Time frame: 2 months following initiation of treatment
Brief Resilience Scale
Time frame: 5 months following initiation of treatment
Acceptance and Action Questionnaire
Time frame: Prior to initiation of treatment
Acceptance and Action Questionnaire
Time frame: 2 months following initiation of treatment
Acceptance and Action Questionnaire
Time frame: 5 months following initiation of treatment
Self Efficacy
Time frame: Prior to initiation of treatment
Self Efficacy
Time frame: 2 months following initiation of treatment
Self Efficacy
Time frame: 5 months following initiation of treatment
Locus of control questionnaire
Time frame: Prior to initiation of treatment
Locus of control questionnaire
Time frame: 2 months following initiation of treatment
Locus of control questionnaire
Time frame: 5 months following initiation of treatment
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 2 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Syed S Wahid, Doctor of Public Health principal investigator
Georgetown University
Anne Hilger, PhD principal investigator
World Bank
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community worker training and Referral to Health System in people with Distress, Psychological and Depression - Major Depressive Disorder, run by Georgetown University at 1 site in Senegal.
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 2 inclusion and 2 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 2 May 2025. 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 Senegal. 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?
Engagement (time frame: From enrollment to the end of treatment at 5 weeks). The study lists 3 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 2 May 2025.