- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07588516
Dynamic Multilevel Processes of Recovery in Therapeutic Communities in Mexico (DICO Model) (DICO)
Comprehensive Behavioral Community Dynamics (DICO): A Prospective Longitudinal Study of Multilevel Community Processes in Therapeutic Communities for Substance Use Treatment in Mexico
This study aims to develop and empirically evaluate the Dinámica Integral Conductual Comunitaria (DICO) model, a multilevel framework that conceptualizes recovery from substance use disorders as a dynamic process emerging from the interaction between individual behavioral variables, social contingencies, and community-level factors within therapeutic communities in Mexico.
A prospective longitudinal design with intensive repeated measures will be implemented over 8 to 12 weeks. Data will be collected using ecological momentary assessment (EMA), psychometric instruments, behavioral records, and semi-structured interviews.
The study seeks to model recovery trajectories as nonlinear dynamic systems, identifying critical transitions, instability patterns, and contextual moderators associated with treatment adherence and relapse risk.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
The study integrates three analytical levels:
- Individual behavioral processes (e.g., craving, psychological flexibility)
- Community-level dynamics (e.g., cohesion, reinforcement contingencies)
- Cultural-contextual factors relevant to Mexican therapeutic communities
Quantitative data will be collected through high-frequency EMA and longitudinal assessments, enabling the estimation of dynamic parameters using nonlinear modeling techniques (e.g., differential equations, network analysis).
Qualitative data from semi-structured interviews will provide contextual interpretation of observed behavioral trajectories and system transitions.
The study does not involve manipulation or assignment to interventions; it is designed to observe naturally occurring processes within residential treatment settings.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lauro Gutiérrez Castro, Mtro.
- Numéro de téléphone: +523314696107
- E-mail: saraqael_sefer@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: Ricardo Fernandez
- Numéro de téléphone: +52 1 33 1544 5474
Lieux d'étude
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Jalisco
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Ajijic, Jalisco, Mexique, 45920
- Comunidad Terapéutica Under The Tree
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Contact:
- Ricardo Fernandez
- Numéro de téléphone: +52 1 33 1544 5474
- E-mail: saraqael_sefer@hotmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
Adult individuals undergoing residential treatment for substance use disorders in therapeutic communities in Mexico. The population is characterized by varying levels of substance dependence severity, psychosocial vulnerability, and exposure to structured community-based treatment environments that emphasize behavioral regulation, peer support, and institutional norms.
Participants are embedded in a communal living setting where daily routines, social interactions, and reinforcement contingencies are structured by the therapeutic model, providing a naturalistic context for observing multilevel behavioral and recovery processes.
La description
Inclusion Criteria:
- Adults aged 18 years or older
- Currently enrolled in a residential therapeutic community for substance use treatment
- Minimum stay of at least 7 days prior to baseline assessment
- Ability to understand and provide informed consent
- Expected availability for participation during the 8-12 week follow-up period
Exclusion Criteria:
- Acute psychotic symptoms or severe psychiatric decompensation that interferes with participation
- Severe cognitive impairment limiting comprehension of study procedures
- Current medical instability requiring immediate external intervention
- Refusal to participate in any component of the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Therapeutic Community Residents
Adult residents undergoing residential treatment for substance use in therapeutic communities in Mexico.
Participants are followed prospectively for 8-12 weeks using intensive longitudinal assessment, including ecological momentary assessment (EMA), psychometric measures, behavioral logs, and qualitative interviews.
No experimental manipulation or assignment to interventions is performed.
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Real-time data collection method using mobile devices to assess momentary fluctuations in craving, psychological flexibility, and social context multiple times per day.
This procedure is used for observational measurement only and does not constitute a therapeutic intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Adherence - Length of Stay
Délai: From admission to discharge (up to 12 weeks)
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Length of stay in treatment (number of days from admission to discharge), obtained from clinical records.
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From admission to discharge (up to 12 weeks)
|
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Disengagement - Total Score on Brief Disengagement Scale
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Total score on the Brief Disengagement Scale (3 items, each scored from 0 to 10; total range: 0 to 30).
Higher scores indicate greater disengagement from treatment.
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Craving Intensity - Single-Item Scale
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Self-reported craving intensity using a single-item scale (0 to 10; 0 = no craving, 10 = extreme craving).
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Contextual Rumination - Total Score on the Brief Contextual Rumination Scale (BCRS-10)
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Total score on the Brief Contextual Rumination Scale (EBRC-10).
Range: 0 to 40.
Higher scores indicate greater rumination associated with substance use.
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
|
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Temporal Variability of Craving
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Within-participant temporal variance of craving scores derived from repeated measurements.
Higher values indicate greater instability.
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
|
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Autocorrelation of Craving (Lag-1)
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Lag-1 autocorrelation coefficient of craving time series.
Higher values indicate greater temporal persistence of craving states.
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychological Flexibility - Total Score on the Acceptance and Action Questionnaire-II (AAQ-II)
Délai: Week 1 (baseline) and Week 12 (discharge).
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Total score on the Acceptance and Action Questionnaire-II (AAQ-II).
Range: 7 to 49 points.
A higher score indicates a worse outcome (greater experiential avoidance, lower psychological flexibility).
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Week 1 (baseline) and Week 12 (discharge).
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Community Cohesion - Mean Score on the Brief Cohesion Scale (RBDC-2D)
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Mean score of two items (each scored 0 to 10): perceived group belonging and trust in peers, derived from the Brief Community Dynamics Record (RBDC-2D).
Range: 0 to 10. Higher scores indicate greater cohesion.
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
|
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Perceived Social Support - Single-Item Score
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Single-item score (0 to 10): perceived support from peers or staff.
Higher scores indicate greater perceived support.
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
|
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Prosocial Behavior - Participation and Cooperation Index (RBDC-2D)
Délai: Every 48 hours from Day 1 through Week 12 (up to 12 weeks).
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Composite index calculated as the sum of three items (each scored 0 to 3): participation in activities, cooperation with peers, and mutual help.
Total range: 0 to 9. Higher scores indicate greater prosocial behavior.
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Every 48 hours from Day 1 through Week 12 (up to 12 weeks).
|
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Perceived Institutional Punitiveness - Single Item from RBDC-2D
Délai: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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Single-item score (0 to 10): perceived harshness or unfairness of rules or sanctions.
Higher scores indicate greater perceived punitiveness.
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Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
|
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Global Network Strength derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Time Series
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Global strength (sum of absolute edge weights) estimated using graphical vector autoregression (gVAR).
Unit: standardized Z-score.
Higher values indicate greater overall connectivity among behavioral variables.
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Node Centrality of Craving derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Data
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Standardized Z-score representing node centrality (expected influence) of craving within the temporal network.
Higher values indicate greater influence on other variables.
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Node Centrality of Contextual Rumination derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Data
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Standardized Z-score representing node centrality (expected influence) of contextual rumination (EBRC-10) within the temporal network.
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Node Centrality of Disengagement - Temporal Network Analysis (gVAR Model)
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Standardized Z-score representing node centrality (expected influence) of impulse/urgency within the temporal network
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Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Node Centrality of Disengagement - Temporal Network Analysis (gVAR Model)
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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Standardized Z-score representing node centrality (expected influence) of disengagement within the temporal network.
|
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
|
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Node Centrality of Perceived Institutional Punitiveness - Temporal Network Analysis (gVAR Model)
Délai: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
|
Standardized Z-score representing node centrality (expected influence) of perceived institutional punitiveness within the temporal network.
|
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
|
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Perceived Social Support - Total Score on Multidimensional Scale of Perceived Social Support (MSPSS)
Délai: Week 1 (baseline), Week 4, Week 8, and Week 12
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Total score on the Multidimensional Scale of Perceived Social Support (MSPSS).
Range: 12 to 84.
Higher scores indicate greater perceived social support.
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Week 1 (baseline), Week 4, Week 8, and Week 12
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lauro Gutiérrez Castro, Mtro., Under The Tree Miller A.C.
- Chercheur principal: Oswaldo Barrera Torres, Amanecer entre nubes
- Chercheur principal: Erick Rodolfo Guerrero Manjarrez, Universidad Autónoma Indígena de México
- Chercheur principal: Denisse Lizeth Mares Ramírez, Centro de Estudios e Investigaciones en Comportamiento (CEIC)
Publications et liens utiles
Publications générales
- Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Borsboom D, Cramer AO. Network analysis: an integrative approach to the structure of psychopathology. Annu Rev Clin Psychol. 2013;9:91-121. doi: 10.1146/annurev-clinpsy-050212-185608.
- Scheffer M, Bascompte J, Brock WA, Brovkin V, Carpenter SR, Dakos V, Held H, van Nes EH, Rietkerk M, Sugihara G. Early-warning signals for critical transitions. Nature. 2009 Sep 3;461(7260):53-9. doi: 10.1038/nature08227.
- Hofmann SG, Hayes SC. The Future of Intervention Science: Process-Based Therapy. Clin Psychol Sci. 2019 Jan;7(1):37-50. doi: 10.1177/2167702618772296. Epub 2018 May 29.
- Korecki JR, Schwebel FJ, Votaw VR, Witkiewitz K. Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. Subst Abuse Treat Prev Policy. 2020 Jul 29;15(1):51. doi: 10.1186/s13011-020-00293-3.
- Society for Community Research and Action-Community Psychology, Division 27 of the American Psychological Association. The role of recovery residences in promoting long-term addiction recovery. Am J Community Psychol. 2013 Dec;52(3-4):406-11. doi: 10.1007/s10464-013-9602-6. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DICO-CT-MX-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified individual participant data (IPD) underlying the results reported in this study will be available, including ecological momentary assessment (EMA) data, psychometric measures, and behavioral records.
Data will be provided in a secure, encrypted format along with associated metadata, codebooks, and documentation necessary to reproduce the dynamic and network-based analyses.
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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