Pathway-Matched Resilience-Oriented Therapy in Rwanda (RoT-CRT)
2026년 5월 29일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
427
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Eastern Province
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Ngoma, Eastern Province, 르완다
- Community and Health-Centre Settings, Ngoma District
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Nyagatare, Eastern Province, 르완다
- Community and Health-Centre Settings, Nyagatare District
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Northern Province
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Ruhengeri, Northern Province, 르완다
- Community and Health-Centre Settings, Musanze District
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Southern Province
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Nyamagabe, Southern Province, 르완다
- Community and Health-Centre Settings, Nyamagabe District
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Western Province
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Nyabihu, Western Province, 르완다
- Community and Health-Centre Settings, Nyabihu District
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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간섭 없음: 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.
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실험적: 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.
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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.
다른 이름들:
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간섭 없음: 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.
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실험적: 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.
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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.
다른 이름들:
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways
기간: Baseline to immediate post-intervention endline, up to 5 months
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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.
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Baseline to immediate post-intervention endline, up to 5 months
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Change in resilience across Resilience-Oriented Therapy pathways
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in depression symptoms in the Resilience-Oriented Therapy emotional-regulation pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in anxiety and related symptoms in the Resilience-Oriented Therapy emotional-regulation pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in borderline and identity-disturbance symptoms in the Resilience-Oriented Therapy identity-development pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in aggression in the Resilience-Oriented Therapy behavioural self-management pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in alcohol abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in drug abuse or dependence risk in the Resilience-Oriented Therapy behavioural self-management pathway
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in emotional wellbeing difficulties
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in collaboration difficulties
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in self-management difficulties
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in hopefulness/agency
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in forgiveness of others
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in perceived stigma of mental illness
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in social cohesion
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in perceived community threat
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in economic security
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in short-term food insecurity
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in long-term food insecurity
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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Change in food security
기간: Baseline to immediate post-intervention endline, up to 5 months.
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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.
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Baseline to immediate post-intervention endline, up to 5 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Alexandros Lordos, PhD, University of Cyprus
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 4월 28일
기본 완료 (실제)
2023년 9월 15일
연구 완료 (실제)
2023년 9월 15일
연구 등록 날짜
최초 제출
2026년 5월 21일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ROT-CRT-RWA-2023
- 122/RNEC/2023 (기타 식별자: Rwanda National Research Ethics Committee approval/reference number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified participant-level data underlying the manuscript analyses.
IPD 공유 기간
Available after publication, with no predetermined end date.
IPD 공유 액세스 기준
Researchers must submit a methodologically sound proposal to the corresponding author.
Access is subject to ethics, data-protection, and partner-organization approvals.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .