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International Latino Research Partnership (ILRP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cambridge Health Alliance
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Universidad Autonoma de Madrid
Information provided by (Responsible Party):
Cambridge Health Alliance
ClinicalTrials.gov Identifier:
NCT02038855
First received: January 14, 2014
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Substance Use (Drugs, Alcohol)
Behavioral: Integrated Intervention for Dual Problems and Early Action

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: International Latino Research Partnership

Resource links provided by NLM:


Further study details as provided by Cambridge Health Alliance:

Primary Outcome Measures:
  • Addiction Severity Index (ASI) - Alcohol (change) [ Time Frame: Baseline, 1 month, 3 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, 1 month, 3 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, 1 month, 3 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.


Secondary Outcome Measures:
  • Generalized Anxiety Disorder 7-item (GAD-7) Scale (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    he GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).

  • Posttraumatic Cognitions Inventory (PTCI) (change) [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    The PTCI is a measure of trauma-related thoughts and beliefs whose items were derived from clinical observations and current theories of post-trauma psychopathology.

  • Patient Health Questionnaire (PHQ-9) (change) [ Time Frame: Baseline, 1 month, 3 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, 1 month, 3 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.


Estimated Enrollment: 360
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)
Arms Assigned Interventions
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.

Detailed 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). 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • History of psychosis, mania or psychotic symptoms using the IMPACT study screener
  • 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 o Paykel suicide questionnaire)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038855

Contacts
Contact: Margarita Alegria, Ph.D. 617-503-8447 malegria@charesearch.org

Locations
United States, Massachusetts
Cambridge Health Alliance
Somerville, Massachusetts, United States, 02143
Spain
Vall d'Hebron University Hospital Not yet recruiting
Barcelona, Catalonia, Spain
Contact: Francisco Collazos, MD       fcollazos@vhebron.net   
Principal Investigator: Francisco Collazos, MD         
Universidad Autonoma de Madrid Medical School Not yet recruiting
Madrid, Spain
Contact: Enrique Baca-Garcia, Ph.D.       ebacgar2@yahoo.es   
Principal Investigator: Enrique Baca-Garcia, Ph.D.         
Sponsors and Collaborators
Cambridge Health Alliance
Hospital Vall d'Hebron
Universidad Autonoma de Madrid
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT02038855     History of Changes
Other Study ID Numbers: CHA-IRB-0910/06/12, R01DA034952-01A1
Study First Received: January 14, 2014
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cambridge Health Alliance:
Dual-diagnosis
Latino
Mental health
Substance use
HIV risk

ClinicalTrials.gov processed this record on November 24, 2014