Overview

This trial is active, not recruiting.

Condition substance use (drugs, alcohol)
Treatment integrated intervention for dual problems and early action
Sponsor Massachusetts General Hospital
Collaborator Hospital Vall d'Hebron
Start date April 2014
End date August 2016
Trial size 360 participants
Trial identifier NCT02038855, CHA-IRB-0910/06/12, R01DA034952-01A1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 10 session intervention administered in person and via telephone.
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)
Patients in this arm receive usual care for dual-diagnosis symptoms of mental health and substance use. They receive 5 check-in calls from a care manager to assess safety.

Primary Outcomes

Measure
Addiction Severity Index (ASI) - Alcohol (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Addiction Severity Index (ASI) - Drugs (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Change on Urine Drug Test (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months

Secondary Outcomes

Measure
Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
PTSD Checklist for DSM-V (PCL-5)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Patient Health Questionnaire (PHQ-9) (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Fagerström Test for Nicotine Dependence (change)
time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Hopkins Symptom Checklist-20
time frame: Baseline, 2 months, 4 months, 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Latino migrants - Must speak English or Spanish - 18-70 years of age - Screen positive to at least one substance use and one mental health problem Exclusion Criteria: - Current or recent (last 3 months) substance use treatment (more than 1 visit with a provider at a behavioral health clinic) - Planning to receive behavioral health services (i.e., have an appointment scheduled in the next 2 months) - Evidence that the patient lacks capacity to consent to the study - Evidence of current suicidal risk or harm to others (affirmative responses to questions 4 and/or 5 on Paykel suicide questionnaire)- patient can be rescreened in 30 days

Additional Information

Official title International Latino Research Partnership
Principal investigator Margarita Alegria, Ph.D.
Description 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). The 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. 5 Research interviews will be conducted to assess outcomes, for patients in both the intervention and usual care arms.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.