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Pathway-Matched Resilience-Oriented Therapy in Rwanda

A Pragmatic, Pathway-Stratified Cluster-Randomized Waitlist-Controlled Trial of Three Variants of Resilience-Oriented Therapy in Rwanda

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07621731
Acronym
RoT-CRT
Enrollment
427
Registered
2026-06-02
Start date
2023-04-28
Completion date
2023-09-15
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression, Anxiety, Depression, Mental Health, Psychological Trauma, Psychosocial Functioning, Stress Disorders, Post-Traumatic, Substance-related Disorders

Keywords

Rwanda, genocide against the Tutsi, Resilience-Oriented Therapy, societal healing, pathway stratification, cluster randomized trial, waitlist control, group psychotherapy, transdiagnostic intervention, resilience

Brief 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.

Detailed description

Resilience-Oriented Therapy (RoT) is a structured, trauma-informed, resilience-oriented group intervention developed for psychosocial recovery in post-genocide Rwanda. The intervention is organized around six broad phases: engagement and hope-building; psychoeducation about trauma, distress, and resilience; strengthening self-care and resilience practices; socioemotional skills acquisition; relational, socio-economic, and civic reintegration work; and follow-up or maintenance. Sessions were delivered by trained facilitators or mental-health practitioners. The study used a pragmatic, pathway-stratified, cluster-randomized waitlist-controlled design. Participants were identified through a wider societal-healing screening process across five districts in Rwanda. Individuals with acute clinical risk were referred for appropriate clinical or hospital support. Remaining eligible adults were screened for intervention fit and routed to one of three RoT variants. The emotion-regulation variant (RoT-ER) targeted internalizing distress, including depression, anxiety, rumination, emotion dysregulation, and social withdrawal. The identity-development variant (RoT-ID) targeted alienation, shame, emptiness, identity disturbance, and belonging-related difficulties. The behavioural self-management variant (RoT-BSM) targeted aggression, alcohol or substance misuse, impulse regulation, and interpersonal responsibility. Within each variant pathway, clusters were randomized to immediate RoT or waitlist control. Waitlist-control participants did not receive the assigned RoT variant during the baseline-to-endline evaluation period and were to be invited to participate after the evaluation exercise where feasible. The baseline cohort included 427 participants across 52 clusters: 173 in the RoT-ER pathway, 120 in the RoT-ID pathway, and 134 in the RoT-BSM pathway. Endline data were observed for 394 participants; missing endline records were handled in the manuscript analysis using multiple imputation. The trial evaluated whether pathway-matched RoT improved clinical and psychosocial outcomes from baseline to immediate post-intervention endline. General outcomes included post-traumatic stress symptoms and resilience across all pathways. Variant-specific outcomes included depression and anxiety/cross-diagnostic symptoms in RoT-ER, borderline/identity disturbance symptoms in RoT-ID, and aggression, alcohol abuse/dependence, and drug abuse/dependence in RoT-BSM. Secondary outcomes included socioemotional difficulties, hopefulness/agency, forgiveness of others, stigma, social cohesion, perceived community threat, economic security, food insecurity, and food security.

Interventions

BEHAVIORALResilience-Oriented Therapy - Emotion-Regulation Variant

RoT-ER is a culturally adapted, group-based psychosocial intervention variant focused on internalizing distress. Sessions emphasize psychoeducation, emotion regulation, distress tolerance, self-care and resilience practices, hope and agency, and group-based social support.

BEHAVIORALResilience-Oriented Therapy - Identity-Development Variant

RoT-ID is a culturally adapted, group-based psychosocial intervention variant focused on alienation, shame, emptiness, identity disturbance, and belonging-related difficulties. Sessions emphasize coherent self-understanding, constructive social identity, relational repair, and resilience practices.

BEHAVIORALResilience-Oriented Therapy - Behavioural Self-Management Variant

RoT-BSM is a culturally adapted, group-based psychosocial intervention variant focused on aggression, alcohol or substance misuse, impulse regulation, accountability, and interpersonal responsibility. Sessions emphasize self-management, responsible relationships, and reintegration into family and community life.

Sponsors

Alexandros Lordos, PhD
Lead SponsorOTHER
Centre for Sustainable Peace and Democratic Development
CollaboratorOTHER
University of Rwanda
CollaboratorOTHER
Interpeace
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Participants and implementers necessarily knew whether RoT was delivered during the evaluation period. Baseline and endline assessors were not involved in intervention delivery; however, endline masking could not be fully maintained because participants could disclose whether they had received the intervention.

Intervention model description

This was a pragmatic, pathway-stratified cluster-randomized waitlist-controlled study. Screening assigned participants to one of three Resilience-Oriented Therapy variant pathways based on clinical profile: emotion regulation, identity development, or behavioural self-management. Within each pathway, local clusters were randomized to immediate RoT or waitlist control. Primary comparisons were pathway-specific.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathwaysBaseline to immediate post-intervention endline, up to 5 monthsPost-traumatic stress symptoms were measured with a genocide-adapted four-item mean score from the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Items were rated from 0 to 4; the mean score ranges from 0 to 4, with higher scores indicating worse post-traumatic stress symptoms.
Change in resilience across Resilience-Oriented Therapy pathwaysBaseline to immediate post-intervention endline, up to 5 months.Resilience was measured with the 10-item Connor-Davidson Resilience Scale. Items were summed to a total score ranging from 0 to 40, with higher scores indicating greater resilience.
Change in depression symptoms in the Resilience-Oriented Therapy emotional-regulation pathwayBaseline to immediate post-intervention endline, up to 5 months.Depression symptoms were measured with the Beck Depression Inventory-Short Form cognitive-affective subscale. The 13 items are summed to a total score ranging from 0 to 39, with higher scores indicating worse depression symptoms.
Change in anxiety and related symptoms in the Resilience-Oriented Therapy emotional-regulation pathwayBaseline to immediate post-intervention endline, up to 5 months.Anxiety and related cross-diagnostic symptoms were measured with a 10-item cross-diagnostic symptom severity scale. Scores range from 0 to 40, with higher scores indicating worse anxiety and related internalizing symptoms.
Change in borderline and identity-disturbance symptoms in the Resilience-Oriented Therapy identity-development pathwayBaseline to immediate post-intervention endline, up to 5 months.Borderline and identity-disturbance symptoms were measured with the McLean Screening Instrument for Borderline Personality Disorder. The 10 yes/no items are summed to a total score ranging from 0 to 10, with higher scores indicating more borderline and identity-disturbance symptoms.
Change in aggression in the Resilience-Oriented Therapy behavioural self-management pathwayBaseline to immediate post-intervention endline, up to 5 months.Aggression was measured with 13 retained items from the Aggression Questionnaire. Items were averaged to a mean score ranging from 1 to 5, with higher scores indicating greater aggression.
Change in alcohol abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathwayBaseline to immediate post-intervention endline, up to 5 months.Alcohol abuse or dependence risk was measured with the six alcohol-use items from the Psychiatric Diagnostic Screening Questionnaire. Yes/no items are summed to a total score ranging from 0 to 6, with higher scores indicating greater alcohol abuse or dependence risk.
Change in drug abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathwayBaseline to immediate post-intervention endline, up to 5 months.Drug abuse or dependence risk was measured with the six drug-use items from the Psychiatric Diagnostic Screening Questionnaire. Yes/no items are summed to a total score ranging from 0 to 6, with higher scores indicating greater drug abuse or dependence risk.

Secondary

MeasureTime frameDescription
Change in emotional wellbeing difficultiesBaseline to immediate post-intervention endline, up to 5 months.Emotional wellbeing difficulties were measured with the emotional-wellbeing subscale from the locally developed socioemotional-skills measure. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater emotional-wellbeing difficulties.
Change in collaboration difficultiesBaseline to immediate post-intervention endline, up to 5 months.Collaboration difficulties were measured with the collaboration subscale from the locally developed socioemotional-skills measure. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater collaboration difficulties.
Change in self-management difficultiesBaseline to immediate post-intervention endline, up to 5 months.Self-management difficulties were measured with the self-management subscale from the locally developed socioemotional-skills measure. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater self-management difficulties.
Change in hopefulness/agencyBaseline to immediate post-intervention endline, up to 5 months.Hopefulness and agency were measured with four agency-oriented hope items. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater hopefulness and agency.
Change in forgiveness of othersBaseline to immediate post-intervention endline, up to 5 months.Forgiveness of others was measured with a retained two-item mean score derived from the Heartland Forgiveness Scale after reliability review. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater forgiveness of others.
Change in perceived stigma of mental illnessBaseline to immediate post-intervention endline, up to 5 months.Perceived stigma was measured with a five-item perceived stigma of mental illness scale adapted for the programme. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater perceived stigma.
Change in social cohesionBaseline to immediate post-intervention endline, up to 5 months.Social cohesion was measured with seven retained items from the Social Cohesion Scale used in the Rwanda societal-healing programme. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater social cohesion.
Change in perceived community threatBaseline to immediate post-intervention endline, up to 5 months.Perceived community threat was measured with four items from the Social Cohesion Scale. Items were averaged to a mean score ranging from 1 to 4, with higher scores indicating greater perceived community threat.
Change in economic securityBaseline to immediate post-intervention endline, up to 5 months.Economic security was measured with programme items assessing whether the household had enough money for basic needs. Items were averaged to a mean score ranging from 0 to 3, with higher scores indicating greater economic security.
Change in short-term food insecurityBaseline to immediate post-intervention endline, up to 5 months.Short-term food insecurity was measured with Food Security Consumption Coping Strategy Index items covering the previous seven days. Scores range from 0 to 84, with higher scores indicating worse short-term food insecurity.
Change in long-term food insecurityBaseline to immediate post-intervention endline, up to 5 months.Long-term food insecurity was measured with Food Security Consumption Coping Strategy Index items covering the previous 12 months. Scores range from 0 to 12, with higher scores indicating worse long-term food insecurity.
Change in food securityBaseline to immediate post-intervention endline, up to 5 months.Food security was measured with programme food-security items derived from the food-consumption coping strategy indicators. Scores range from 0 to 84, with higher scores indicating greater food security.

Countries

Rwanda

Contacts

PRINCIPAL_INVESTIGATORAlexandros Lordos, PhD

University of Cyprus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026