Motivational enhancement treatment in outpatient addiction centers: A multisite randomized trial / Intervención de incremento motivacional en centros ambulatorios para las adicciones: un ensayo aleatorizado multicéntrico

Background/Objectives: Motivational Enhancement Treatment in Spanish (METS) is a brief intervention aimed at resolving patient ambivalence towards behavior change that has demonstrated efficacy in substance use disorder treatment to reduce use and increase treatment engagement in different populations. In order to have evidence for its implementation in Mexico, a multi-site, randomized, two-arm, controlled clinical trial was conducted at three outpatient addiction treatment centers in the country to compare the effect of METS with Counseling as Usual (CAU). Method: One hundred and twenty patients were randomized to receive three sessions of METS (n = 54) or CAU (n = 66) during the first four weeks of treatment and were assessed during the following 12 weeks. Primary outcome measures were self-reported days of substance use and of treatment services utilization, which were tested using Generalized Estimating Equations. Results: Results associated both conditions with significant changes in substance use over, whereas there were no differences between conditions in substance use or in service utilization. Conclusions: Findings do not support the hypothesis that METS is more effective than CAU, but suggest that brief interventions at treatment initiation may improve patient outcomes (AU)

Antecedentes/Objetivos: La Intervención de Incremento Motivacional (METS) es una intervención breve para resolver la ambivalencia del paciente con respecto a su comportamiento y ha demostrado eficacia en distintas poblaciones para reducir el consumo de sustancias e incrementar la asistencia al tratamiento en adicciones. Con el objetivo de generar evidencia para su implementación en México, se desarrolló un ensayo clínico controlado, multisede, aleatorizado, de dos brazos en tres centros de tratamiento ambulatorio para adicciones, para comparar el efecto de METS con el del tratamiento usual (CAU). Método: Ciento veinte pacientes fueron aleatorizados a tres sesiones de METS (n = 54) o CAU (n = 66) durante las primeras cuatro semanas de tratamiento y evaluados durante las siguientes doce. Se midieron resultados mediante autoinforme de días con consumo de sustancias y días de utilización de servicios, los cuales fueron analizados mediante ecuaciones de estimación generalizadas. Resultados: Los resultados asociaron ambas condiciones a cambios significativos en uso de sustancias a lo largo del tiempo, pero no demostraron diferencias entre condiciones en el uso de sustancias o en la utilización de servicios. Conclusiones: Los hallazgos contradicen la hipótesis de superioridad de METS sobre CAU, pero sugieren que las intervenciones breves al inicio del tratamiento pudieran mejorar la respuesta del paciente (AU)

Motivational enhancement treatment in outpatient addiction centers: A multisite randomized trial.

BACKGROUND/OBJECTIVES: Motivational Enhancement Treatment in Spanish (METS) is a brief intervention aimed at resolving patient ambivalence towards behavior change that has demonstrated efficacy in substance use disorder treatment to reduce use and increase treatment engagement in different populations. In order to have evidence for its implementation in Mexico, a multi-site, randomized, two-arm, controlled clinical trial was conducted at three outpatient addiction treatment centers in the country to compare the effect of METS with Counseling as Usual (CAU). METHOD: One hundred and twenty patients were randomized to receive three sessions of METS (n = 54) or CAU (n = 66) during the first four weeks of treatment and were assessed during the following 12 weeks. Primary outcome measures were self-reported days of substance use and of treatment services utilization, which were tested using Generalized Estimating Equations. RESULTS: Results associated both conditions with significant changes in substance use over, whereas there were no differences between conditions in substance use or in service utilization. CONCLUSIONS: Findings do not support the hypothesis that METS is more effective than CAU, but suggest that brief interventions at treatment initiation may improve patient outcomes.

Antecedentes/Objetivos: La Intervención de Incremento Motivacional (METS) es una intervención breve para resolver la ambivalencia del paciente con respecto a su comportamiento y ha demostrado eficacia en distintas poblaciones para reducir el consumo de sustancias e incrementar la asistencia al tratamiento en adicciones. Con el objetivo de generar evidencia para su implementación en México, se desarrolló un ensayo clínico controlado, multi-sede, aleatorizado, de dos brazos en tres centros de tratamiento ambulatorio para adicciones, para comparar el efecto de METS con el del tratamiento usual (CAU). Método: Ciento veinte pacientes fueron aleatorizados a tres sesiones de METS (n = 54) o CAU (n = 66) durante las primeras cuatro semanas de tratamiento y evaluados durante las siguientes doce. Se midieron resultados mediante autoinforme de días con consumo de sustancias y días de utilización de servicios, los cuales fueron analizados mediante ecuaciones de estimación generalizadas. Resultados: Los resultados asociaron ambas condiciones a cambios significativos en uso de sustancias a lo largo del tiempo, pero no demostraron diferencias entre condiciones en el uso de sustancias o en la utilización de servicios. Conclusiones: Los hallazgos contradicen la hipótesis de superioridad de METS sobre CAU, pero sugieren que las intervenciones breves al inicio del tratamiento pudieran mejorar la respuesta del paciente.

Co-Occurring Disorders: A Challenge for Mexican Community-Based Residential Care Facilities for Substance Use.

OBJECTIVE: In Mexico, specialized treatment services for people with co-occurring disorders are limited within public health services, while private options are deemed too costly. More than 2,000 community-based residential care facilities have risen as an alternative and are the main source of treatment for individuals with substance use disorders; however, suboptimal practices within such facilities are common. Information on the clinical characteristics of patients receiving care in these facilities is scarce and capacity to provide high-quality care for co-occurring disorders is unknown. The aims of this study were to examine the prevalence of co-occurring disorders in patients receiving treatment for substance use in these community-based residential centers and to assess whether the presence of co-occurring disorders is associated with higher severity of substance use, psychiatric symptomatology, and other health risks. METHODS: This study was conducted with 601 patients receiving treatment for substance use disorders at 30 facilities located in five Mexican states, recruited in 2013 and 2014. Patients were assessed with self-report measures on substance use, service utilization, suicidality, HIV risk behaviors, psychiatric symptomatology, and psychiatric disorder diagnostic criteria. RESULTS: The prevalence of any co-occurring disorder in this sample was 62.6%. Antisocial personality disorder was the most prevalent (43.8%), followed by major depressive disorder (30.9%). The presence of a co-occurring disorder was associated with higher severity of psychiatric symptoms (aB = .496, SE = .050, p < .05); more days of substance use (aB = .219, SE = .019, p < .05); current suicidal ideation (aOR = 5.07, 95% CI [2.58, 11.17]; p < .05), plans (aOR = 5.17 95% CI [2.44, 12.73]; p < .05), and attempts (aOR = 6.43 95% CI [1.83, 40.78]; p < .05); more sexual risk behaviors; and more contact with professional services (aOR = 1.77, 95% CI [1.26, 2.49], p < .05). CONCLUSIONS: Co-occurring disorders are highly prevalent in community-based residential centers in Mexico and are associated with significantly increased probability of other health risks. This highlights the need to develop care standards for this population and the importance of clinical research in these settings.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico / Transferencia de tecnología para la implantación de una red de investigaciones clínicas sobre el tratamiento de la drogadicción y los problemas de salud mental en México

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011–2013. The Florida Node Alliance shared the “know how” for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Los países de ingresos bajos o medios (PIBM) carecen de una infraestructura de investigación y de la capacidad para llevar a cabo investigaciones clínicas rigurosas sobre la eficacia del tratamiento de la drogadicción y los problemas de salud mental que orienten la práctica clínica. Se estableció una asociación entre la Florida Node Alliance de la National Drug Abuse Treatment Clinical Trials Network de los Estados Unidos y el Instituto Nacional de Psiquiatría de México con objeto de mejorar la práctica en materia de tratamiento de la drogadicción en México. La finalidad de esta asociación fue la de crear una red nacional mexicana de investigaciones clínicas constituida por investigadores y proveedores de tratamiento de la drogadicción capaces de ejecutar ensayos clínicos aleatorizados de eficacia en entornos comunitarios. Se implantó un modelo de transferencia de tecnologías. La Florida Node Alliance compartió el el conocimiento y la experiencia para la creación de la infraestructura de investigación con objeto de ejecutar investigaciones clínicas aleatorizadas en programas comunitarios, por medio de módulos de capacitación común y específica, entrenamiento en funciones específicas, emparejamientos, modelado, vigilancia y retroalimentación. El proceso de transferencia de tecnología fue de tipo bidireccional en cuanto se basó en la retroalimentación sobre la viabilidad y la adecuación cultural para el contexto en el que se llevaron a cabo las prácticas. El Instituto, a su vez, lideró la iniciativa para crear la red nacional de investigadores y profesionales de México y llevar a cabo el primer ensayo. Un modelo colaborativo de transferencia de tecnología resultó útil para la creación de una red mexicana de investigadores y proveedores de tratamiento capaz de cambiar las prácticas nacionales de investigación y tratamiento en materia de drogadicción. Se exponen las consideraciones clave para la transferencia transnacional de tecnología.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico / Transferencia de tecnología para la implantación de una red de investigaciones clínicas sobre el tratamiento de la drogadicción y los problemas de salud mental en México

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Los países de ingresos bajos o medios (PIBM) carecen de una infraestructura de investigación y de la capacidad para llevar a cabo investigaciones clínicas rigurosas sobre la eficacia del tratamiento de la drogadicción y los problemas de salud mental que orienten la práctica clínica. Se estableció una asociación entre la Florida Node Alliance de la National Drug Abuse Treatment Clinical Trials Network de los Estados Unidos y el Instituto Nacional de Psiquiatría de México con objeto de mejorar la práctica en materia de tratamiento de la drogadicción en México. La finalidad de esta asociación fue la de crear una red nacional mexicana de investigaciones clínicas constituida por investigadores y proveedores de tratamiento de la drogadicción capaces de ejecutar ensayos clínicos aleatorizados de eficacia en entornos comunitarios. Se implantó un modelo de transferencia de tecnologías. La Florida Node Alliance compartió el el conocimiento y la experiencia para la creación de la infraestructura de investigación con objeto de ejecutar investigaciones clínicas aleatorizadas en programas comunitarios, por medio de módulos de capacitación común y específica, entrenamiento en funciones específicas, emparejamientos, modelado, vigilancia y retroalimentación. El proceso de transferencia de tecnología fue de tipo bidireccional en cuanto se basó en la retroalimentación sobre la viabilidad y la adecuación cultural para el contexto en el que se llevaron a cabo las prácticas. El Instituto, a su vez, lideró la iniciativa para crear la red nacional de investigadores y profesionales de México y llevar a cabo el primer ensayo. Un modelo colaborativo de transferencia de tecnología resultó útil para la creación de una red mexicana de investigadores y proveedores de tratamiento capaz de cambiar las prácticas nacionales de investigación y tratamiento en materia de drogadicción. Se exponen las consideraciones clave para la transferencia transnacional de tecnología.

Technology transfer for the implementation of a clinical trials network on drug abuse and mental health treatment in Mexico.

Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clinical practice. A partnership between the Florida Node Alliance of the United States National Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of this partnership was to develop a Mexican national clinical trials network of substance abuse researchers and providers capable of implementing effectiveness randomized clinical trials in community-based settings. A technology transfer model was implemented and ran from 2011-2013. The Florida Node Alliance shared the "know how" for the development of the research infrastructure to implement randomized clinical trials in community programs through core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and feedback. The technology transfer process was bi-directional in nature in that it was informed by feedback on feasibility and cultural appropriateness for the context in which practices were implemented. The Institute, in turn, led the effort to create the national network of researchers and practitioners in Mexico and the implementation of the first trial. A collaborative model of technology transfer was useful in creating a Mexican researcher-provider network that is capable of changing national practice in substance abuse research and treatment. Key considerations for transnational technology transfer are presented.

Characteristics of a treatment-seeking population in outpatient addiction treatment centers in Mexico.

BACKGROUND: Baseline patients' characteristics are critical for treatment planning, as these can be moderators of treatment effects. In Mexico, information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics. OBJECTIVE: This paper presents and analyses demographic characteristics, substance use related problems, clinical features, and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health. METHODS: A total of 120 participants were assessed prior randomization. Chi square or F-tests were used to compare sites across variables. Spearman correlation was used to associate negative consequences of substance use and motivation to change. RESULTS: The majority of participants were men, and the most prevalent substances reported were alcohol, marijuana, and cocaine. Participants were predominantly on the contemplation or action stage of change, and this was correlated with the perception of the negative consequences associated with substance use. Participants reported a high prevalence of substance use related problems. CONCLUSIONS: Substance use related problems, clinical features, and addiction severity reported by treatment seekers are important characteristics to take into account when planning treatment as they facilitate tailoring treatment to meet patients' needs.

Comorbilidad de los trastornos por consumo de sustancias con otros trastornos psiquiátricos en Centros Residenciales de Ayuda-Mutua para la Atención de las Adicciones / Comorbidity of substance abuse disorders with other psychiatric disorders in Mutual-Aid Residential Treatment Centers

La comorbilidad de los trastornos por consumo de sustancias con otros trastornos mentales presenta una importante prevalencia; se ha reportado que ésta es mayor en los centros de tratamiento psiquiátrico (2050%) y para las adicciones (50-75%) en comparación con la población abierta. Una modalidad de Ayuda-Mutua para la atención de las adicciones común en México es la de los Centros Residenciales y Casas de Recuperación para las adicciones, también llamados "anexos". El objetivo del estudio fue estimar la prevalencia de comorbilidad de los trastornos por consumo de sustancias con otros trastornos psiquiátricos en una muestra de participantes de sexo masculino adscritos a los Centros Residenciales de Ayuda-Mutua para la Atención de las Adicciones (CRAMAA). Se captó a un total de 535 participantes, de los cuales 346 cumplieron los criterios de inclusión y fueron evaluados. La evaluación diagnóstica de los trastornos por uso de sustancias y los 17 trastornos psiquiátricos comórbidos se realizó con la Entrevista Internacional Diagnóstica Compuesta (WMH-CIDI). Los resultados mostraron que 75.72% cumplía con criterios diagnósticos para algún trastorno psiquiátrico comórbido, siendo los más prevalentes los trastornos por déficit de atención y comportamiento perturbador, seguidos por los trastornos de ansiedad, la ansiedad por separación, los trastornos afectivos, los trastornos por control de impulsos y con menor frecuencia los trastornos de la conducta alimentaria. En la mayoría de los casos (83.59%), los trastornos psiquiátricos comórbidos precedieron a los trastornos adictivos. Este estudio constituye una aportación que puede considerarse para futuras propuestas en políticas públicas, que se traduzcan en acciones para ofertar servicios que atiendan las adicciones y los trastornos psiquiátricos de manera integral.

Substance use disorders have a high degree of comorbidity with other psychiatric disorders; it has been reported that the prevalence of comorbidity is higher in psychiatric (20-50%) and addiction (50-75%) treatment settings than in household or student populations. Because of limited treatment alternatives and greater treatment needs, Mutual-Aid groups have become relevant in the last decades. A modality of Mutual-Aid for addiction treatment that has proliferated in Mexico has taken the form of residential Mutual-Aid centers called "anexos" in Spanish. The objective of this study was to estimate the prevalence of lifetime comorbidity between substance use disorders and psychiatric disorders in those who attended these residential Mutual-Aid centers. The initial sample consisted of 535 male participants diagnosed with a substance use disorder, but only 346 fulfilled the inclusion criteria to continue with the evaluation. Only males were included as the participating centers only admit males. Psychiatric diagnosis was evaluated with the Composite International Diagnostic Interview (WMH-CIDI) using DSM-IV criteria. The results showed that 75.72% met criteria for any comorbid psychiatric disorder, the most frequent being attention deficit and conduct disorders, followed by anxiety disorders, separation anxiety disorders, mood disorders, impulse control disorders and least frequently eating disorders. While the study is limited by its non-representative sample, the findings provide valuable information for a hidden population for which there is a dearth of information and points to the need for integrative services which address both addiction and comorbid psychiatric disorders simultaneously.

Consideraciones metodológicas y éticas para la conducción de ensayos clínicos controlados aleatorizados (ECCA) sobre intervenciones para las adicciones / Methodological and ethical aspects in conducting randomized controlled clinical trials (RCT) for addictive disorder's interventions

According to epidemiologic reports, the harmful use of alcohol and illicit drugs has increased among the Mexican population. This use is associated to several risks and issues that affect public health and the public well-being of the country. In this article it is acknowledged the need for development of treatment models and interventions whose therapeutic value is demonstrated by scientific evidence, that respond to the attention needs of the population affected by substance use in our country and that can be generalized in community clinical practice. In clinical research, randomized controlled clinical trials (RCT's) are the "gold standard" to demonstrate the effect of a therapeutic intervention. A randomized controlled clinical trial is a prospective study in which the effect, value and safety of one or various experimental interventions are tested against a "control" intervention in human subjects. Acknowledging that in Mexico there is a lack of research on addiction treatment that is compliant with all the requirements to be considered as an RCT, this article presents some methodological and ethical considerations that are neccesary for their design and conduction. These considerations include from the establishment of a relevant research question and objectives, adequate study design, development of strategies for data management, statistical analysis, monitoring of interventions, safety monitoring and research quality assurance and protection of human subjects.

Según reportes epidemiológicos, el consumo nocivo de alcohol y drogas ilegales dentro de la población mexicana ha ido en aumento, lo que se asocia a varios riesgos o problemáticas que afectan la salud y bienestar públicos del país. Se reconoce la necesidad de desarrollar modelos de tratamiento e intervenciones cuyo valor terapéutico esté respaldado por la evidencia científica, que respondan a las necesidades de atención de la población afectada por el consumo de sustancias en nuestro país y que puedan generalizarse en la práctica clínica comunitaria. Dentro de la investigación clínica, el "estándar de oro" para demostrar el efecto de una intervención terapéutica son los ensayos clínicos controlados aleatorizados (ECCA). Un ECCA es un estudio prospectivo en el cual se prueba el efecto, valor y seguridad de una o varias intervenciones experimentales contra una intervención "control" en sujetos humanos. Reconociendo que en México hay una falta de investigaciones sobre tratamientos para las adicciones que cumplan con todos los requisitos para ser considerados ECCA, en este artículo se presentan distintas consideraciones metodológicas y éticas que deben tomarse en cuenta para su diseño y conducción en la materia; abarcando aspectos que parten desde el establecimiento de una pregunta y objetivos relevantes hasta el diseño adecuado del estudio y el desarrollo de estrategias para la administración de datos, análisis estadístico, monitoreo de las intervenciones, monitoreo de seguridad y aseguramiento de la calidad de la investigación y protección de los sujetos humanos que participan.