- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958840
Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Major Depressive Disorder (MDD) is highly prevalent and widely-impairing across racial and ethnic groups. Higher rates of MDD have been observed among Latinos with limited English-language proficiency relative to the general population. Although MDD is a highly treatable condition, barriers to treatment access and delivery have been implicated in precluding this group from utilizing and receiving mental health services. Fortunately, Latinos tend to endorse positive attitudes toward psychosocial treatments for depression by applying the valued belief of "poner de su parte" or being able to do their part in one's recovery, a concept that is highly consistent with the framework of behavioral treatments for depression.
The Behavioral Activation Treatment for Depression (BATD), based on reinforcement theory, may be well-equipped to address disparities associated with higher depression prevalence rates and receipt of care among Latinos with limited English-language proficiency. Following a small, open-label pilot study that yielded very promising results of BATD, the current study will consist of a larger, randomized control trial (N = 60) that will compare BATD to Supportive Counseling in outcomes of depression, activity level, and contact with positive reinforcement in the environment.
Initial eligibility will be determined via a telephone screener, which will include questions from the Mood Disorders, Substance Use and Dependence, and Psychotic Disorders modules of the Structured Clinical Interview for DSM-IV-TR (SCID-IV; First, Spitzer, Gibbon & Williams, 2002).
Inclusion criteria consist of the following: 1) be a minimum of 18 years of age, 2) be of Latino descent, 3) report limited English language proficiency, 4) meet current MDD criteria, 5) have completed the 4th grade or higher either in their country of origin or in the US, 6) not have current substance abuse or dependence, 7) have no Bipolar or Psychotic Disorders, and 9) not be currently receiving psychotherapy, and 10) if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use. Excluded individuals will be referred to mental health resources within the community.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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College Park, Maryland, United States, 20742
- University of Maryland- College Park
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be a minimum of 18 years of age
- be of Latino descent
- report limited English language proficiency
- meet current MDD criteria
- have completed the 4th grade or higher either in their country of origin or in the US
- not have current substance abuse or dependence
- have no Bipolar or Psychotic Disorders
- not be currently receiving psychotherapy
- if currently taking antidepressants, demonstrate pharmacological stability as indicated by 3 or more consecutive months of use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Activation Treatment for Depression
Behavioral Activation Condition - 10 sessions
|
|
Active Comparator: Supportive Counseling
Supportive Counseling Condition - 10 sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Beck Depression Inventory- II
Time Frame: Assessed at every session and at the 1-month follow-up
|
Assessed at every session and at the 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavioral Activation for Depression Scale
Time Frame: Administered at each session and at the 1-month follow-up
|
Administered at each session and at the 1-month follow-up
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reward Probability Index
Time Frame: Administered at each session and at the 1-month follow-up
|
Administered at each session and at the 1-month follow-up
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1F31MH098512-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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