An interventional study of Resilience-Oriented Therapy - Emotion-Regulation Variant and Resilience-Oriented Therapy - Identity-Development Variant in Mental Health, Psychological Trauma and Stress Disorders, Post-Traumatic, sponsored by Alexandros Lordos, PhD. Completed at 5 sites in Rwanda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Alexandros Lordos, PhD · Not applicable, Interventional, and Treatment
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.
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.
140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.
This study's enrollment of 427 is above the median of 80 across 108 interventional studies indexed under Psychological Trauma.
Browse Psychological Trauma studies →Alexandros Lordos, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Psychological Trauma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in emotion-regulation pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.
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
Participants in identity-development pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.
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
Participants in behavioural self-management pathway clusters randomized to waitlist control during the evaluation period; offered RoT after endline where feasible.
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Plan to share: Yes — De-identified participant-level data underlying the manuscript analyses.
Supporting information: Study protocol, Statistical analysis plan, 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.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Alexandros Lordos, PhD