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

29 de maio de 2026 atualizado por: Alexandros Lordos, PhD

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

427

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
Outros nomes:
  • RoT-ER
  • RoT Emotion-Regulation Variant
Sem intervenção: 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.
Comportamental: 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.
Outros nomes:
  • RoT-ID
  • RoT Identity-Development Variant
Sem intervenção: 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.
Comportamental: 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.
Outros nomes:
  • RoT-BSM
  • RoT Behavioral Self-Management Variant
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways
Prazo: 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.
Baseline to immediate post-intervention endline, up to 5 months
Change in resilience across Resilience-Oriented Therapy pathways
Prazo: 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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in depression symptoms in the Resilience-Oriented Therapy emotional-regulation pathway
Prazo: 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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in anxiety and related symptoms in the Resilience-Oriented Therapy emotional-regulation pathway
Prazo: 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.
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
Prazo: 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.
Baseline to immediate post-intervention endline, up to 5 months.
Change in aggression in the Resilience-Oriented Therapy behavioural self-management pathway
Prazo: 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.
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
Prazo: 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.
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
Prazo: 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.
Baseline to immediate post-intervention endline, up to 5 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in emotional wellbeing difficulties
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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
Prazo: Baseline to immediate post-intervention endline, up to 5 months.
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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Alexandros Lordos, PhD

Colaboradores

University of Rwanda
Centre for Sustainable Peace and Democratic Development
Interpeace

Investigadores

  • Investigador principal: Alexandros Lordos, PhD, University of Cyprus

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de abril de 2023

Conclusão Primária (Real)

15 de setembro de 2023

Conclusão do estudo (Real)

15 de setembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2026

Primeira postagem (Real)

2 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ROT-CRT-RWA-2023
  • 122/RNEC/2023 (Outro identificador: Rwanda National Research Ethics Committee approval/reference number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified participant-level data underlying the manuscript analyses.

Prazo de Compartilhamento de IPD

Available after publication, with no predetermined end date.

Critérios de acesso de compartilhamento IPD

Researchers must submit a methodologically sound proposal to the corresponding author. Access is subject to ethics, data-protection, and partner-organization approvals.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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