Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos

NCT ID: NCT01958840

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-10-31

Brief Summary

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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, contact with positive reinforcement in the environment, treatment satisfaction, therapeutic alliance, and perceived stigma. In addition, participants' adherence rates to each of the therapies and their maintenance of clinical gains at a 1-month follow-up, will be examined.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Behavioral Activation Treatment for Depression

Behavioral Activation Condition - 10 sessions

Group Type EXPERIMENTAL

Behavioral Activation for Depression Treatment

Intervention Type BEHAVIORAL

Supportive Counseling

Supportive Counseling Condition - 10 sessions

Group Type ACTIVE_COMPARATOR

Supportive Counseling

Intervention Type BEHAVIORAL

Interventions

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Behavioral Activation for Depression Treatment

Intervention Type BEHAVIORAL

Supportive Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, College Park

OTHER

Sponsor Role lead

Responsible Party

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Joe Smith

Director - HRPP (A. Collado is no longer at UMD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland- College Park

College Park, Maryland, United States

Site Status

Countries

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United States

References

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Collado A, Long KE, MacPherson L, Lejuez CW. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial. Trials. 2014 Jun 18;15:231. doi: 10.1186/1745-6215-15-231.

Reference Type DERIVED
PMID: 24938081 (View on PubMed)

Other Identifiers

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1F31MH098512-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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