CompletedNot Applicable

Pathway-Matched Resilience-Oriented Therapy in Rwanda

Rwanda427 participantsStarted 2023-04-28

Plain-language summary

This pragmatic, pathway-stratified, cluster-randomized waitlist-controlled trial evaluated Resilience-Oriented Therapy (RoT), a culturally adapted group-based psychosocial intervention for post-genocide Rwanda. Community screening assigned eligible adults to one of three RoT variant pathways based on presenting profile: emotion regulation, identity development, or behavioural self-management. Within each pathway, local clusters were randomized to immediate RoT or waitlist control. The baseline cohort included 427 participants across 52 clusters in five Rwandan districts. Outcomes were assessed at baseline and immediate post-intervention endline from April to September 2023.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult participant aged 18 years or older. * Living in or connected to a selected RoT-eligible cluster in one of the five study districts in Rwanda. * Screened through the wider societal-healing screening process and assigned to one of the RoT variant pathways based on presenting mental-health or socioemotional profile. * Able and willing to complete baseline assessment and, if allocated to immediate RoT, participate in group sessions. * Written informed consent obtained according to local ethics requirements. Exclusion Criteria: * Acute clinical risk, including suicidality or other indication requiring more intensive clinical or hospital referral as first-line response. * Primary needs better matched to another intervention pathway after staged screening, including family-level healing or community sociotherapy. * Unable to provide informed consent or safely participate in group sessions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways

Timeframe: Baseline to immediate post-intervention endline, up to 5 months

Change in resilience across Resilience-Oriented Therapy pathways

Timeframe: Baseline to immediate post-intervention endline, up to 5 months.

Change in depression symptoms in the Resilience-Oriented Therapy emotional-regulation pathway

Timeframe: Baseline to immediate post-intervention endline, up to 5 months.

Change in anxiety and related symptoms in the Resilience-Oriented Therapy emotional-regulation pathway

Timeframe: Baseline to immediate post-intervention endline, up to 5 months.

Change in borderline and identity-disturbance symptoms in the Resilience-Oriented Therapy identity-development pathway

Timeframe: Baseline to immediate post-intervention endline, up to 5 months.

Change in aggression in the Resilience-Oriented Therapy behavioural self-management pathway

Timeframe: Baseline to immediate post-intervention endline, up to 5 months.

Trial details

NCT IDNCT07621731

SponsorAlexandros Lordos, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-15

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