Pathway-Matched Resilience-Oriented Therapy in Rwanda (RoT-CRT)

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

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.

Study Overview

• Status: Completed
• Conditions: Aggression; Depression; Stress Disorders, Post-Traumatic; Anxiety; Mental Health; Substance-related Disorders; Psychological Trauma; Psychosocial Functioning
• Intervention / Treatment: Behavioral: Resilience-Oriented Therapy - Emotion-Regulation Variant; Behavioral: Resilience-Oriented Therapy - Identity-Development Variant; Behavioral: Resilience-Oriented Therapy - Behavioural Self-Management Variant

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.

• Study Type: Interventional
• Enrollment (Actual): 427
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Eastern Province
    • Ngoma, Eastern Province, Rwanda
      • Community and Health-Centre Settings, Ngoma District
    • Nyagatare, Eastern Province, Rwanda
      • Community and Health-Centre Settings, Nyagatare District
  • Northern Province
    • Ruhengeri, Northern Province, Rwanda
      • Community and Health-Centre Settings, Musanze District
  • Southern Province
    • Nyamagabe, Southern Province, Rwanda
      • Community and Health-Centre Settings, Nyamagabe District
  • Western Province
    • Nyabihu, Western Province, Rwanda
      • Community and Health-Centre Settings, Nyabihu District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resilience-Oriented Therapy for Emotion Regulation Immediate; Participants in clusters randomized to receive the emotion-regulation variant of Resilience-Oriented Therapy during the evaluation period.	Behavioral: Resilience-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.; Other Names: RoT-ER; RoT Emotion-Regulation Variant
No Intervention: Resilience-Oriented Therapy for Emotion Regulation Waitlist Control; Participants in emotion-regulation pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.
Experimental: Resilience-Oriented Therapy for Identity Development Immediate; Participants in clusters randomized to receive the identity-development variant of Resilience-Oriented Therapy during the evaluation period.	Behavioral: Resilience-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.; Other Names: RoT-ID; RoT Identity-Development Variant
No Intervention: Resilience-Oriented Therapy for Identity Development Waitlist Control; Participants in identity-development pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.
Experimental: Resilience-Oriented Therapy for Behavioral Self-Management Immediate; Participants in clusters randomized to receive the behavioural self-management variant of Resilience-Oriented Therapy during the evaluation period.	Behavioral: Resilience-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.; Other Names: RoT-BSM; RoT Behavioral Self-Management Variant
No Intervention: Resilience-Oriented Therapy for Behavioral Self-Management Waitlist Control; Participants in behavioural self-management pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways	Post-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.	Baseline to immediate post-intervention endline, up to 5 months
Change in resilience across Resilience-Oriented Therapy pathways	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in depression symptoms in the Resilience-Oriented Therapy emotional-regulation pathway	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in anxiety and related symptoms in the Resilience-Oriented Therapy emotional-regulation pathway	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.	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	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in aggression in the Resilience-Oriented Therapy behavioural self-management pathway	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in alcohol abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathway	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in drug abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathway	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.	Baseline to immediate post-intervention endline, up to 5 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional wellbeing difficulties	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in collaboration difficulties	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in self-management difficulties	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in hopefulness/agency	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in forgiveness of others	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in perceived stigma of mental illness	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in social cohesion	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in perceived community threat	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in economic security	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in short-term food insecurity	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in long-term food insecurity	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.	Baseline to immediate post-intervention endline, up to 5 months.
Change in food security	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.	Baseline to immediate post-intervention endline, up to 5 months.

Collaborators and Investigators

• Sponsor: Alexandros Lordos, PhD
• Collaborators: University of Rwanda; Centre for Sustainable Peace and Democratic Development; Interpeace
• Investigators: Principal Investigator: Alexandros Lordos, PhD, University of Cyprus

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: resilience; Rwanda; cluster randomized trial; group psychotherapy; transdiagnostic intervention; genocide against the Tutsi; Resilience-Oriented Therapy; societal healing; pathway stratification; waitlist control
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Aberrant Motor Behavior in Dementia; Mental Disorders; Behavioral Symptoms; Chemically-Induced Disorders; Stress Disorders, Traumatic; Behavior; Personal Satisfaction; Social Behavior; Psychological Trauma; Anxiety Disorders; Depression; Substance-Related Disorders; Aggression; Stress Disorders, Post-Traumatic; Psychological Well-Being
• Other Study ID Numbers: ROT-CRT-RWA-2023; 122/RNEC/2023 (Other Identifier: Rwanda National Research Ethics Committee approval/reference number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level data underlying the manuscript analyses.
• IPD Sharing Time Frame: Available after publication, with no predetermined end date.
• IPD Sharing Access Criteria: Researchers must submit a methodologically sound proposal to the corresponding author. Access is subject to ethics, data-protection, and partner-organization approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No