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

29. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

427

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • RoT-ER
  • RoT Emotion-Regulation Variant
Kein Eingriff: 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.
Verhalten: 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.
Andere Namen:
  • RoT-ID
  • RoT Identity-Development Variant
Kein Eingriff: 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.
Verhalten: 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.
Andere Namen:
  • RoT-BSM
  • RoT Behavioral Self-Management Variant
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in emotional wellbeing difficulties
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Alexandros Lordos, PhD

Mitarbeiter

University of Rwanda
Centre for Sustainable Peace and Democratic Development
Interpeace

Ermittler

  • Hauptermittler: Alexandros Lordos, PhD, University of Cyprus

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. April 2023

Primärer Abschluss (Tatsächlich)

15. September 2023

Studienabschluss (Tatsächlich)

15. September 2023

Studienanmeldedaten

Zuerst eingereicht

21. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

Available after publication, with no predetermined end date.

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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