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Dynamic Multilevel Processes of Recovery in Therapeutic Communities in Mexico (DICO Model) (DICO)

8. května 2026 aktualizováno: Lauro Gutiérrez Castro, Under The Tree Therapeutic Community

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

The study integrates three analytical levels:

  1. Individual behavioral processes (e.g., craving, psychological flexibility)
  2. Community-level dynamics (e.g., cohesion, reinforcement contingencies)
  3. 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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

60

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Ricardo Fernandez
  • Telefonní číslo: +52 1 33 1544 5474

Studijní místa

  • Mexiko
    • Jalisco
      • Ajijic, Jalisco, Mexiko, 45920
        • Comunidad Terapéutica Under The Tree
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: Ecological Momentary Assessment (EMA)
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Treatment Adherence - Length of Stay
Časové okno: From admission to discharge (up to 12 weeks)
Length of stay in treatment (number of days from admission to discharge), obtained from clinical records.
From admission to discharge (up to 12 weeks)
Disengagement - Total Score on Brief Disengagement Scale
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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.
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Craving Intensity - Single-Item Scale
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Self-reported craving intensity using a single-item scale (0 to 10; 0 = no craving, 10 = extreme craving).
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Contextual Rumination - Total Score on the Brief Contextual Rumination Scale (BCRS-10)
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Total score on the Brief Contextual Rumination Scale (EBRC-10). Range: 0 to 40. Higher scores indicate greater rumination associated with substance use.
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Temporal Variability of Craving
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Within-participant temporal variance of craving scores derived from repeated measurements. Higher values indicate greater instability.
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Autocorrelation of Craving (Lag-1)
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Lag-1 autocorrelation coefficient of craving time series. Higher values indicate greater temporal persistence of craving states.
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Psychological Flexibility - Total Score on the Acceptance and Action Questionnaire-II (AAQ-II)
Časové okno: Week 1 (baseline) and Week 12 (discharge).
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).
Week 1 (baseline) and Week 12 (discharge).
Community Cohesion - Mean Score on the Brief Cohesion Scale (RBDC-2D)
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
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.
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Perceived Social Support - Single-Item Score
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Single-item score (0 to 10): perceived support from peers or staff. Higher scores indicate greater perceived support.
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Prosocial Behavior - Participation and Cooperation Index (RBDC-2D)
Časové okno: Every 48 hours from Day 1 through Week 12 (up to 12 weeks).
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.
Every 48 hours from Day 1 through Week 12 (up to 12 weeks).
Perceived Institutional Punitiveness - Single Item from RBDC-2D
Časové okno: Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Single-item score (0 to 10): perceived harshness or unfairness of rules or sanctions. Higher scores indicate greater perceived punitiveness.
Every 48 hours from Week 1 through Week 12 (up to 12 weeks)
Global Network Strength derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Time Series
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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.
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Node Centrality of Craving derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Data
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Standardized Z-score representing node centrality (expected influence) of craving within the temporal network. Higher values indicate greater influence on other variables.
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Node Centrality of Contextual Rumination derived from Temporal Network Analysis (graphical VAR) of RBDC-2D and EBRC-10 Data
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Standardized Z-score representing node centrality (expected influence) of contextual rumination (EBRC-10) within the temporal network.
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Node Centrality of Disengagement - Temporal Network Analysis (gVAR Model)
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Standardized Z-score representing node centrality (expected influence) of impulse/urgency within the temporal network
Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
Node Centrality of Disengagement - Temporal Network Analysis (gVAR Model)
Časové okno: Derived from repeated measurements collected every 48 hours from Week 1 through Week 12
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
Node Centrality of Perceived Institutional Punitiveness - Temporal Network Analysis (gVAR Model)
Časové okno: 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
Perceived Social Support - Total Score on Multidimensional Scale of Perceived Social Support (MSPSS)
Časové okno: Week 1 (baseline), Week 4, Week 8, and Week 12
Total score on the Multidimensional Scale of Perceived Social Support (MSPSS). Range: 12 to 84. Higher scores indicate greater perceived social support.
Week 1 (baseline), Week 4, Week 8, and Week 12

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Under The Tree Therapeutic Community

Vyšetřovatelé

  • Vrchní vyšetřovatel: Lauro Gutiérrez Castro, Mtro., Under The Tree Miller A.C.
  • Vrchní vyšetřovatel: Oswaldo Barrera Torres, Amanecer entre nubes
  • Vrchní vyšetřovatel: Erick Rodolfo Guerrero Manjarrez, Universidad Autónoma Indígena de México
  • Vrchní vyšetřovatel: Denisse Lizeth Mares Ramírez, Centro de Estudios e Investigaciones en Comportamiento (CEIC)

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

26. září 2026

Dokončení studie (Odhadovaný)

2. října 2026

Termíny zápisu do studia

První předloženo

20. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

8. května 2026

První zveřejněno (Aktuální)

14. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • DICO-CT-MX-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

De-identified individual participant data and supporting materials will be available beginning 6 months after study completion and will remain accessible for 5 years following publication of the primary results.

Kritéria přístupu pro sdílení IPD

Access to de-identified individual participant data (IPD) and supporting materials will be granted to qualified researchers affiliated with academic or clinical institutions. Requests must include a brief research proposal outlining objectives, methodology, and intended use of the data. Proposals will be reviewed by an independent committee to ensure scientific merit and ethical compliance. Approved users will have access to de-identified datasets, metadata, codebooks, and analytic code necessary for reproducibility. Data will be provided via secure, encrypted transfer after execution of a Data Sharing Agreement (DSA) prohibiting re-identification and unauthorized redistribution.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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