Substance Use (Drugs, Alcohol)ILRPNCT02038855
International Latino Research Partnership
A study testing Integrated Intervention for Dual Problems and Early Action in people with Substance Use (Drugs, Alcohol), run by Massachusetts General Hospital at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Substance Use (Drugs, Alcohol)
- What is being tested?
- Integrated Intervention for Dual Problems and Early Action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2014to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Vall d'Hebron University Hospital
Barcelona, Catalonia
Universidad Autonoma de Madrid Medical School
Madrid
United States1 site
Cambridge Health Alliance
Somerville, Massachusetts, 02143
About this study
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.
Read the 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). 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.
- Conditions
- Substance Use (Drugs, Alcohol)
- Being tested
- Integrated Intervention for Dual Problems and Early Action
- Keywords
- Dual-diagnosis, Latino, Mental health, Substance use, HIV risk
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Intervention for Dual Problems and Early ActionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 months, 4 months, 6 months, 12 months
Secondary outcomes (4)
Generalized Anxiety Disorder 7-item (GAD-7) Scale (change)
The GAD-7 is a questionnaire for screening and severity measuring of generalized anxiety disorder (GAD).
Measured: Baseline, 2 months, 4 months, 6 months, 12 months
PTSD Checklist for DSM-V (PCL-5)
The PCL-5 is is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
Measured: Baseline, 2 months, 4 months, 6 months, 12 months
Patient Health Questionnaire (PHQ-9) (change)
The PHQ-9 is a 9-item screening questionnaire to determine level of depressive disorder.
Measured: Baseline, 2 months, 4 months, 6 months, 12 months
Hopkins Symptom Checklist-20
The HSCL-20 is a symptom inventory for depression that indicates severity of psychological distress.
Measured: Baseline, 2 months, 4 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startApr 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use (Drugs, Alcohol)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Universidad Autonoma de Madrid, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
- Investigators
- Margarita Alegria, Ph.D., Principal investigator, CMMHR, Cambridge Health Alliance and Harvard Medical SchoolEnrique Baca-Garcia, Ph.D., Principal investigator, Universidad Autonoma de MadridFrancisco Collazos, MD, Principal investigator, Vall d'Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038855
- Sponsor's protocol ID
- CHA-IRB-0910/06/12
- Other IDs
- R01DA034952-01A1
- Acronym
- ILRP
- Status last verified
- Apr 2017
- First submitted
- 14 Jan 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30737609Alegria 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.
PubMed 30646205
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Latino Research Partnership
- ClinicalTrials.gov ID
- NCT02038855
- Acronym / sponsor ID
- ILRP / CHA-IRB-0910/06/12
- Conditions
- Substance Use (Drugs, Alcohol)
- Keywords
- Dual-diagnosis, Latino, Mental health, Substance use, HIV risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Universidad Autonoma de Madrid, National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2014
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IIDEA | Active comparator | Behavioral: Integrated Intervention for Dual Problems and Early ActionPatients in the Integrated Intervention for Dual Problems and Early Action (IIDEA) arm will receive the 10 session intervention administered in person and via telephone. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Intervention for Dual Problems and Early ActionIntegrated 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. | Behavioural | IIDEA |
Primary outcome
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.
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.
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.
4 secondary outcomes
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
Hopkins Symptom Checklist-20
Time frame: Baseline, 2 months, 4 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Derived from this study: PubMed 30737609Levison 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.
- Derived from this study: PubMed 30646205Alegria 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.
- Project WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Alegria, Ph.D. principal investigator
CMMHR, Cambridge Health Alliance and Harvard Medical School
Enrique Baca-Garcia, Ph.D. principal investigator
Universidad Autonoma de Madrid
Francisco Collazos, MD principal investigator
Vall d'Hebron University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Intervention for Dual Problems and Early Action in people with Substance Use (Drugs, Alcohol), run by Massachusetts General Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addiction Severity Index (ASI) - Alcohol (change) (time frame: Baseline, 2 months, 4 months, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.