DepressionPhase 1NCT00356304
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
A Phase 1 study testing Motivational interviewing and Treatment as usual in people with Depression, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Motivational interviewing and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jul 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as Hispanic
- DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)
- Currently taking antidepressant medication
Who cannot join
- Clinically significant suicidal ideation
- DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry
- Unstable general medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University Behavioral Healthcare
New Brunswick, New Jersey, 08901
About this study
Official title: Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.
Read the detailed description
Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.
Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.
- Conditions
- Depression
- Being tested
- Motivational interviewing, Treatment as usual
- Keywords
- Dysthymia, Major Depression, Hispanics, Latinos, Motivational Interviewing, Adherence
- Medical subject headings
- Depression, Dysthymic Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.
Treatment as usualBehavioural
Participants will continue with their normal treatment regimen as usual.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive motivational interviewing in addition to their antidepressant therapy Receives: Behavioral: Motivational interviewing |
| 2 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence, as Measured by Electronic Pill Container
Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.
Measured: Measured immediately post-treatment and at Months 2 and 5 months follow-ups
Secondary outcomes (3)
Treatment Retention
Measured: Measured at Month 5
Beck Depression Inventory-II (BDI-II)
The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.
0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: Measured at Month 5
Medication Attitudes
Measured: Measured at Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alejandro Interian, Ph.D., National Institute of Mental Health (NIMH)
- Investigators
- Alejandro Interian, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356304
- Sponsor's protocol ID
- K23MH074860
- Other IDs
- K23MH074860, DSIR 8K-RT
- Status last verified
- Apr 2014
- First submitted
- 21 Jul 2006
- Last updated
- 8 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591.
PubMed 18048562Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16.
PubMed 20630257Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8.
PubMed 23300127
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
- ClinicalTrials.gov ID
- NCT00356304
- Acronym / sponsor ID
- K23MH074860
- Conditions
- Depression
- Keywords
- Dysthymia, Major Depression, Hispanics, Latinos, Motivational Interviewing, Adherence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.
Detailed description
Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.
Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Motivational interviewingParticipants will receive motivational interviewing in addition to their antidepressant therapy |
| 2 | Active comparator | Behavioral: Treatment as usualParticipants will receive treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identifies as Hispanic
- DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)
- Currently taking antidepressant medication
Key exclusion criteria (3 listed)
- Clinically significant suicidal ideation
- DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry
- Unstable general medical condition
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 |
|---|---|---|
| Motivational interviewingParticipants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration. | Behavioural | 1 |
| Treatment as usualParticipants will continue with their normal treatment regimen as usual. | Behavioural | 2 |
Primary outcome
Medication Adherence, as Measured by Electronic Pill Container
Time frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups
Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.
3 secondary outcomes
Treatment Retention
Time frame: Measured at Month 5
Beck Depression Inventory-II (BDI-II)
Time frame: Measured at Month 5
Medication Attitudes
Time frame: Measured at Month 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18048562Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591.
- Background: PubMed 20630257Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16.
- Results publication: PubMed 23300127Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8.
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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.
Alejandro Interian, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational interviewing and Treatment as usual in people with Depression, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 3 inclusion and 3 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Adherence, as Measured by Electronic Pill Container (time frame: Measured immediately post-treatment and at Months 2 and 5 months follow-ups). 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 NCT00356304, which also lists 3 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 8 May 2014.