NCT02038855

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

January 14, 2014

Last Update Submit

April 27, 2017

Conditions

Substance Use (Drugs, Alcohol)

Keywords

Dual-diagnosisLatinoMental healthSubstance useHIV risk

Outcome Measures

Primary Outcomes (3)

  • Addiction Severity Index (ASI) - Alcohol (change)

    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.

    Baseline, 2 months, 4 months, 6 months, 12 months

  • Addiction Severity Index (ASI) - Drugs (change)

    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.

    Baseline, 2 months, 4 months, 6 months, 12 months

  • Change on Urine Drug Test (change)

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

    Baseline, 2 months, 4 months, 6 months, 12 months

Secondary Outcomes (4)

  • Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)

    Baseline, 2 months, 4 months, 6 months, 12 months

  • PTSD Checklist for DSM-V (PCL-5)

    Baseline, 2 months, 4 months, 6 months, 12 months

  • Patient Health Questionnaire (PHQ-9) (change)

    Baseline, 2 months, 4 months, 6 months, 12 months

  • Hopkins Symptom Checklist-20

    Baseline, 2 months, 4 months, 6 months, 12 months

Study Arms (2)

IIDEA

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.

Behavioral: Integrated Intervention for Dual Problems and Early Action

Usual Care

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.

Interventions

Integrated Intervention for Dual Problems and Early ActionBEHAVIORAL

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.

IIDEA

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Latino migrants
  • Must speak English or Spanish
  • years of age
  • Screen positive to at least one substance use and one mental health problem

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cambridge Health Alliance

Somerville, Massachusetts, 02143, United States

Location

Vall d'Hebron University Hospital

Barcelona, Catalonia, Spain

Location

Universidad Autonoma de Madrid Medical School

Madrid, Spain

Location

Related Publications (2)

  • Levison JH, Alegria M, Wang Y, Markle SL, Fuentes L, Mejia DL, Tarbox A, Albarracin Garcia L, Cellerino L, El-Bassel N. High HIV/STI Test Acceptance Through a Behavioral Health Encounter in Latino Immigrants with Substance Use and Mental Health Problems. AIDS Behav. 2019 Apr;23(4):835-846. doi: 10.1007/s10461-019-02413-y.

    PMID: 30737609DERIVED

  • Alegria M, Falgas-Bague I, Collazos F, Carmona Camacho R, Lapatin Markle S, Wang Y, Baca-Garcia E, Le Cook B, Chavez LM, Fortuna L, Herrera L, Qureshi A, Ramos Z, Gonzalez C, Aroca P, Albarracin Garcia L, Cellerino L, Villar A, Ali N, Mueser KT, Shrout PE. Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186927. doi: 10.1001/jamanetworkopen.2018.6927.

    PMID: 30646205DERIVED

Related Links

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Disparities Research Unit

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 17, 2014

Study Start

April 1, 2014

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Locations

ES(2)US(1)