Pathway-Matched Resilience-Oriented Therapy in Rwanda

NCT07621731 | Completed

• 2 other identifiers: ROT-CRT-RWA-2023122/RNEC/2023
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• Change in emotional wellbeing difficulties

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

• Change in collaboration difficulties

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

• Change in self-management difficulties

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

• Change in hopefulness/agency

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

• Change in forgiveness of others

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

Study Arms (6)

Resilience-Oriented Therapy for Emotion Regulation Immediate

EXPERIMENTAL

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

Resilience-Oriented Therapy for Emotion Regulation Waitlist Control

NO INTERVENTION

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

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

Resilience-Oriented Therapy for Identity Development Waitlist Control

NO INTERVENTION

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

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

Resilience-Oriented Therapy for Behavioral Self-Management Waitlist Control

NO INTERVENTION

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

Interventions

Resilience-Oriented Therapy - Emotion-Regulation Variant BEHAVIORAL

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.

Also known as: RoT-ER, RoT Emotion-Regulation Variant

Resilience-Oriented Therapy for Emotion Regulation Immediate

Resilience-Oriented Therapy - Identity-Development Variant BEHAVIORAL

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.

Also known as: RoT-ID, RoT Identity-Development Variant

Resilience-Oriented Therapy for Identity Development Immediate

Resilience-Oriented Therapy - Behavioural Self-Management Variant BEHAVIORAL

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.

Also known as: RoT-BSM, RoT Behavioral Self-Management Variant

Resilience-Oriented Therapy for Behavioral Self-Management Immediate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandros Lordos, PhD: lead
• Centre for Sustainable Peace and Democratic Development: collaborator
• Interpeace: collaborator
• University of Rwanda: collaborator

Study Sites (5)

Community and Health-Centre Settings, Ngoma District

Ngoma, Eastern Province, Rwanda

Location

Community and Health-Centre Settings, Nyagatare District

Nyagatare, Eastern Province, Rwanda

Location

Community and Health-Centre Settings, Musanze District

Ruhengeri, Northern Province, Rwanda

Location

Community and Health-Centre Settings, Nyamagabe District

Nyamagabe, Southern Province, Rwanda

Location

Community and Health-Centre Settings, Nyabihu District

Nyabihu, Western Province, Rwanda

Location

MeSH Terms

Conditions

Psychological Well-Being; Psychological Trauma; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders; Aggression; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Aberrant Motor Behavior in Dementia; Social Behavior; Chemically-Induced Disorders

Study Officials

• Alexandros Lordos, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Skills and Resilience Lab, Department of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: April 28, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available after publication, with no predetermined end date.
• Access Criteria: Researchers must submit a methodologically sound proposal to the corresponding author. Access is subject to ethics, data-protection, and partner-organization approvals.

Locations

RW (5)