Pathway-Matched Resilience-Oriented Therapy in Rwanda (RoT-CRT)
2026年5月29日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
427
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Eastern Province
-
Ngoma、Eastern Province、ルワンダ
- Community and Health-Centre Settings, Ngoma District
-
Nyagatare、Eastern Province、ルワンダ
- Community and Health-Centre Settings, Nyagatare District
-
-
Northern Province
-
Ruhengeri、Northern Province、ルワンダ
- Community and Health-Centre Settings, Musanze District
-
-
Southern Province
-
Nyamagabe、Southern Province、ルワンダ
- Community and Health-Centre Settings, Nyamagabe District
-
-
Western Province
-
Nyabihu、Western Province、ルワンダ
- Community and Health-Centre Settings, Nyabihu District
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
|
|
介入なし：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.
|
|
|
実験的：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.
|
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.
他の名前：
|
|
介入なし：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.
|
|
|
実験的：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.
|
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.
他の名前：
|
|
介入なし：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in post-traumatic stress symptoms across Resilience-Oriented Therapy pathways
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in emotional wellbeing difficulties
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alexandros Lordos, PhD、University of Cyprus
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年4月28日
一次修了 (実際)
2023年9月15日
研究の完了 (実際)
2023年9月15日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ROT-CRT-RWA-2023
- 122/RNEC/2023 (その他の識別子：Rwanda National Research Ethics Committee approval/reference number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified participant-level data underlying the manuscript analyses.
IPD 共有時間枠
Available after publication, with no predetermined end date.
IPD 共有アクセス基準
Researchers must submit a methodologically sound proposal to the corresponding author.
Access is subject to ethics, data-protection, and partner-organization approvals.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。