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

Alexandros Lordos, PhD

Status: Completed

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

Treatments: Behavioral: Resilience-Oriented Therapy - Behavioural Self-Management Variant; Behavioral: Resilience-Oriented Therapy - Emotion-Regulation Variant; Behavioral: Resilience-Oriented Therapy - Identity-Development Variant

Study type: Interventional

Funder types: Other

Identifiers

NCT07621731

122/RNEC/2023 (Other Identifier)

ROT-CRT-RWA-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 427 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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427 participants in 6 patient groups

Resilience-Oriented Therapy for Emotion Regulation Immediate

Experimental group

Description:

Participants in clusters randomized to receive the emotion-regulation variant of Resilience-Oriented Therapy during the evaluation period.

Treatment:

Behavioral: Resilience-Oriented Therapy - Emotion-Regulation Variant

Resilience-Oriented Therapy for Emotion Regulation Waitlist Control

No Intervention group

Description:

Participants in emotion-regulation pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.

Resilience-Oriented Therapy for Identity Development Immediate

Experimental group

Description:

Participants in clusters randomized to receive the identity-development variant of Resilience-Oriented Therapy during the evaluation period.

Treatment:

Behavioral: Resilience-Oriented Therapy - Identity-Development Variant

Resilience-Oriented Therapy for Identity Development Waitlist Control

No Intervention group

Description:

Participants in identity-development pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.

Resilience-Oriented Therapy for Behavioral Self-Management Immediate

Experimental group

Description:

Participants in clusters randomized to receive the behavioural self-management variant of Resilience-Oriented Therapy during the evaluation period.

Treatment:

Behavioral: Resilience-Oriented Therapy - Behavioural Self-Management Variant

Resilience-Oriented Therapy for Behavioral Self-Management Waitlist Control

No Intervention group

Description:

Participants in behavioural self-management pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.