- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lauro Gutiérrez Castro, Mtro.
- Número de teléfono: +523314696107
- Correo electrónico: saraqael_sefer@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ricardo Fernandez
- Número de teléfono: +52 1 33 1544 5474
Ubicaciones de estudio
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Jalisco
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Ajijic, Jalisco, México, 45920
- Comunidad Terapéutica Under The Tree
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Contacto:
- Ricardo Fernandez
- Número de teléfono: +52 1 33 1544 5474
- Correo electrónico: saraqael_sefer@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment Adherence - Length of Stay
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Psychological Flexibility - Total Score on the Acceptance and Action Questionnaire-II (AAQ-II)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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 Perceived Institutional Punitiveness - Temporal Network Analysis (gVAR Model)
Periodo de tiempo: 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 perceived institutional punitiveness 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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Perceived Social Support - Total Score on Multidimensional Scale of Perceived Social Support (MSPSS)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lauro Gutiérrez Castro, Mtro., Under The Tree Miller A.C.
- Investigador principal: Oswaldo Barrera Torres, Amanecer entre nubes
- Investigador principal: Erick Rodolfo Guerrero Manjarrez, Universidad Autónoma Indígena de México
- Investigador principal: Denisse Lizeth Mares Ramírez, Centro de Estudios e Investigaciones en Comportamiento (CEIC)
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DICO-CT-MX-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .