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Completed

NCT Number: NCT02038855

International Latino Research Partnership

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.

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Key information

Conditions

Substance Use (Drugs, Alcohol) Behavior Chemically-Induced Disorders Mental Disorders Personal Satisfaction Psychological Well-Being Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron University Hospital, Barcelona, Catalonia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Intervention for Dual Problems and Early Action

Behavioral

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.

Primary outcomes

  1. Addiction Severity Index (ASI) - Alcohol (change)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    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.

  2. Addiction Severity Index (ASI) - Drugs (change)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    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.

  3. Change on Urine Drug Test (change)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    Technical analysis of a biological specimen (urine) to determine the presence or absence of specified parent drugs or their metabolites.

Secondary outcomes

  1. Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).

  2. PTSD Checklist for DSM-V (PCL-5)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    The PCL-5 is is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.

  3. Patient Health Questionnaire (PHQ-9) (change)

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.

  4. Hopkins Symptom Checklist-20

    Time frame: Baseline, 2 months, 4 months, 6 months, 12 months

    The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Hospital Vall d'Hebron
  • National Institute on Drug Abuse (NIDA)
  • Universidad Autonoma de Madrid

Registry information

Acronym: ILRP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2014
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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