Mental HealthRoT-CRTNCT07621731
Pathway-Matched Resilience-Oriented Therapy in Rwanda
A study testing Resilience-Oriented Therapy - Emotion-Regulation Variant, Resilience-Oriented Therapy - Identity-Development Variant and Resilience-Oriented Therapy - Behavioural Self-Management Variant in people with Mental Health and Psychological Trauma, run by Alexandros Lordos, PhD at 5 sites in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Psychological Trauma, Stress Disorders, Post-Traumatic
- What is being tested?
- Resilience-Oriented Therapy - Emotion-Regulation Variant, Resilience-Oriented Therapy - Identity-Development Variant and Resilience-Oriented Therapy - Behavioural Self-Management Variant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 5 sitesRwanda
- Study dates
- 28 Apr 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Rwanda5 sites
Community and Health-Centre Settings, Ngoma District
Ngoma, Eastern Province
Community and Health-Centre Settings, Nyabihu District
Nyabihu, Western Province
Community and Health-Centre Settings, Nyagatare District
Nyagatare, Eastern Province
Community and Health-Centre Settings, Nyamagabe District
Nyamagabe, Southern Province
Community and Health-Centre Settings, Musanze District
Ruhengeri, Northern Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health, Psychological Trauma, Stress Disorders, Post-Traumatic, Depression, Anxiety, Aggression
- Being tested
- Resilience-Oriented Therapy - Emotion-Regulation Variant, Resilience-Oriented Therapy - Identity-Development Variant, Resilience-Oriented Therapy - Behavioural Self-Management Variant
- Keywords
- Rwanda, genocide against the Tutsi, Resilience-Oriented Therapy, societal healing, pathway stratification, cluster randomized trial, waitlist control, group psychotherapy, transdiagnostic intervention, resilience
- Medical subject headings
- Psychological Well-Being, Psychological Trauma, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Aggression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-Oriented Therapy - Emotion-Regulation VariantBehavioural
Also called RoT-ER, RoT 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.
Resilience-Oriented Therapy - Identity-Development VariantBehavioural
Also called RoT-ID, RoT 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.
Resilience-Oriented Therapy - Behavioural Self-Management VariantBehavioural
Also called RoT-BSM, RoT Behavioral 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to immediate post-intervention endline, up to 5 months.
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to immediate post-intervention endline, up to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start28 Apr 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandros Lordos, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Sustainable Peace and Democratic Development, University of Rwanda, Interpeace
- Responsible party
- Sponsor-investigator, Alexandros Lordos, PhD, University of Cyprus
- Investigators
- Alexandros Lordos, PhD, Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621731
- Sponsor's protocol ID
- ROT-CRT-RWA-2023
- Other IDs
- 122/RNEC/2023
- Acronym
- RoT-CRT
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data underlying the manuscript analyses.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Pathway-Stratified Cluster-Randomized Waitlist-Controlled Trial of Three Variants of Resilience-Oriented Therapy in Rwanda
- ClinicalTrials.gov ID
- NCT07621731
- Acronym / sponsor ID
- RoT-CRT / ROT-CRT-RWA-2023
- Conditions
- Mental Health, Psychological Trauma, Stress Disorders, Post-Traumatic, Depression, Anxiety, Aggression
- Keywords
- Rwanda, genocide against the Tutsi, Resilience-Oriented Therapy, societal healing, pathway stratification, cluster randomized trial, waitlist control, group psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Alexandros Lordos, PhDUniversity, hospital or other
- Collaborators
- Centre for Sustainable Peace and Democratic Development, University of Rwanda, Interpeace
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resilience-Oriented Therapy for Emotion Regulation Immediate | Experimental | Behavioral: Resilience-Oriented Therapy - Emotion-Regulation VariantParticipants in clusters randomized to receive the emotion-regulation variant of Resilience-Oriented Therapy during the evaluation period. |
| 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 | Behavioral: Resilience-Oriented Therapy - Identity-Development VariantParticipants in clusters randomized to receive the identity-development variant of Resilience-Oriented Therapy during the evaluation period. |
| 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 | Behavioral: Resilience-Oriented Therapy - Behavioural Self-Management VariantParticipants in clusters randomized to receive the behavioural self-management variant of Resilience-Oriented Therapy during the evaluation period. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience-Oriented Therapy - Emotion-Regulation VariantAlso: RoT-ER, RoT Emotion-Regulation VariantRoT-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. | Behavioural | Resilience-Oriented Therapy for Emotion Regulation Immediate |
| Resilience-Oriented Therapy - Identity-Development VariantAlso: RoT-ID, RoT Identity-Development VariantRoT-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. | Behavioural | Resilience-Oriented Therapy for Identity Development Immediate |
| Resilience-Oriented Therapy - Behavioural Self-Management VariantAlso: RoT-BSM, RoT Behavioral Self-Management VariantRoT-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. | Behavioural | Resilience-Oriented Therapy for Behavioral Self-Management Immediate |
Primary outcome
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways
Time frame: Baseline to immediate post-intervention endline, up to 5 months
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.
Change in resilience across Resilience-Oriented Therapy pathways
Time frame: Baseline 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 pathway
Time frame: Baseline 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 pathway
Time frame: Baseline 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 pathway
Time frame: Baseline 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 pathway
Time frame: Baseline 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 pathway
Time frame: Baseline 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 pathway
Time frame: Baseline 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.
12 secondary outcomes
Change in emotional wellbeing difficulties
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in collaboration difficulties
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in self-management difficulties
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in hopefulness/agency
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in forgiveness of others
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in perceived stigma of mental illness
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in social cohesion
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in perceived community threat
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in economic security
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in short-term food insecurity
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in long-term food insecurity
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Change in food security
Time frame: Baseline to immediate post-intervention endline, up to 5 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data underlying the manuscript analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandros Lordos, PhD principal investigator
University of Cyprus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience-Oriented Therapy - Emotion-Regulation Variant, Resilience-Oriented Therapy - Identity-Development Variant and Resilience-Oriented Therapy - Behavioural Self-Management Variant in people with Mental Health and Psychological Trauma, run by Alexandros Lordos, PhD at 5 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways (time frame: Baseline to immediate post-intervention endline, up to 5 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.