- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Lauro Gutiérrez Castro, Mtro.
- Номер телефона: +523314696107
- Электронная почта: saraqael_sefer@hotmail.com
Учебное резервное копирование контактов
- Имя: Ricardo Fernandez
- Номер телефона: +52 1 33 1544 5474
Места учебы
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Jalisco
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Ajijic, Jalisco, Мексика, 45920
- Comunidad Terapéutica Under The Tree
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Контакт:
- Ricardo Fernandez
- Номер телефона: +52 1 33 1544 5474
- Электронная почта: saraqael_sefer@hotmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
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.
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Treatment Adherence - Length of Stay
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Psychological Flexibility - Total Score on the Acceptance and Action Questionnaire-II (AAQ-II)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Главный следователь: Lauro Gutiérrez Castro, Mtro., Under The Tree Miller A.C.
- Главный следователь: Oswaldo Barrera Torres, Amanecer entre nubes
- Главный следователь: Erick Rodolfo Guerrero Manjarrez, Universidad Autónoma Indígena de México
- Главный следователь: Denisse Lizeth Mares Ramírez, Centro de Estudios e Investigaciones en Comportamiento (CEIC)
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Химически индуцированные расстройства
- Поведение
- Поведение в отношении здоровья
- Расстройства, связанные с употреблением психоактивных веществ
- Приверженность и соблюдение режима лечения
- Поведенческие дисциплины и деятельность
- Психологические тесты
- Экологическая мгновенная оценка
Другие идентификационные номера исследования
- DICO-CT-MX-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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.
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .