International Latino Research Partnership (ILRP)
Through a grant funded by the National Institute on Drug Abuse (NIDA) the Center for Multicultural Mental Health Research at Cambridge Health Alliance is testing a screening and intervention project designed to improve the quality of care for Latino patients with comorbid mental health and substance use problems. We will first test a screening of comorbid problems with patients identified in mental health as well as primary health care. Building on that work, we will test the feasibility, acceptability and efficacy of the "Integrated Intervention for Dual Problems and Early Action" (IIDEA) intervention addressing mental health, substance use, and prevention of HIV, as well as a smoking cessation supplement. The project is being conducted in Massachusetts as well as at two sites in Spain. As such, the proposed ILRP multi-site international project is a critical step towards developing models of integrated care for the large and diverse Latino migrant population and more broadly towards understanding how best to integrate evidence-based assessment and treatments for co-occurring substance and mental health problems and HIV risks.
Substance Use (Drugs, Alcohol)
Behavioral: Integrated Intervention for Dual Problems and Early Action
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||International Latino Research Partnership|
- Addiction Severity Index (ASI) - Alcohol (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Alcohol problem area.
- Addiction Severity Index (ASI) - Drugs (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The ASI is a semi-structured interview designed to address seven potential problem areas in substance-abusing patients; this outcome measure refers to the Drug problem area.
- Change on Urine Drug Test (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.
- Generalized Anxiety Disorder 7-item (GAD-7) Scale (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
- PTSD Checklist for DSM-V (PCL-5) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The PCL-5 is is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
- Patient Health Questionnaire (PHQ-9) (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
- Fagerström Test for Nicotine Dependence (change) [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine.
- Hopkins Symptom Checklist-20 [ Time Frame: Baseline, 2 months, 4 months, 6 months ] [ Designated as safety issue: No ]The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: IIDEA
Patients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 8-10 session intervention administered in person and via telephone.
Behavioral: Integrated Intervention for Dual Problems and Early Action
Integrated Intervention for Dual Problems and Early Action (IIDEA) includes psycho-education, Cognitive Behavioral Therapy and mindfulness; identifies triggers and challenging thoughts; provides motivational techniques for reducing substance use and/or smoking cravings; incorporates cognitive restructuring to identify and correct negative thinking patterns influenced by depression, anxiety and/or trauma; and includes self-monitoring of thoughts and risk behaviors that contribute to substance use, smoking and increased HIV risk.
No Intervention: Usual Care
Patients in this arm receive usual care for dual-diagnosis symptoms of mental health and substance use.
Our study aims to conduct behavioral health services research focused on rapid screening and referral; as well as testing the feasibility, acceptability and efficacy of integrated behavioral health services in primary care clinics for migrant Latinos with co-occurring substance use and mental health problems, and increased risk of HIV.
A key activity for the first phase, the screening project, is administering a screener to at least 450 Latino migrant patients across the 3 sites (n=150 each in Boston, Madrid, and Barcelona) from primary care and behavioral health (substance abuse and mental health) services. We intend to test the referral process for screened participants in need of treatment to identify barriers and streamline the process. We will analyze data to optimize the screening battery and protocol to use in Phase 2, the IIDEA intervention.
In Phase 2, we intend to enroll, randomize and collect data on 360 total patients across the 3 sites - 180 in the intervention condition and 180 in the control condition (120 in each site, 60 in the intervention condition and 60 in the control condition). 8-10 session IIDEA intervention will be offered to Latino patients by trained clinicians with at least a Masters level of training. The intervention is designed to help patients to address and prevent mental health and substance use problems and will be culturally adapted to Latino populations in Boston, Madrid and Barcelona. Usual care - the control group - receives treatment as usual, for patients in primary care identified with a mental health or substance use problem. 4 Research interviews will be conducted to assess outcomes, for patients in both the intervention and usual care arms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02038855
|Contact: Margarita Alegria, Ph.D.||firstname.lastname@example.org|
|United States, Massachusetts|
|Cambridge Health Alliance||Recruiting|
|Somerville, Massachusetts, United States, 02143|
|Contact: Margarita Alegria, Ph.D 617-503-8440 email@example.com|
|Principal Investigator: Margarita Alegria, Ph.D.|
|Vall d'Hebron University Hospital||Not yet recruiting|
|Barcelona, Catalonia, Spain|
|Contact: Francisco Collazos, MD firstname.lastname@example.org|
|Principal Investigator: Francisco Collazos, MD|
|Universidad Autonoma de Madrid Medical School||Not yet recruiting|
|Contact: Enrique Baca-Garcia, Ph.D. email@example.com|
|Principal Investigator: Enrique Baca-Garcia, Ph.D.|
|Principal Investigator:||Margarita Alegria, Ph.D.||CMMHR, Cambridge Health Alliance and Harvard Medical School|
|Principal Investigator:||Enrique Baca-Garcia, Ph.D.||Universidad Autonoma de Madrid|
|Principal Investigator:||Francisco Collazos, MD||Vall d'Hebron University Hospital|