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Clinical Trials/NCT01958840
NCT01958840CompletedNot Applicable

Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos

University of Maryland, College Park1 site in 1 country46 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
Beck Depression Inventory- II

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Behavioral Activation Treatment for Depression

Experimental

Behavioral Activation Condition - 10 sessions

Intervention: Behavioral Activation for Depression Treatment (Behavioral)

Supportive Counseling

Active Comparator

Supportive Counseling Condition - 10 sessions

Intervention: Supportive Counseling (Behavioral)

Outcomes

Primary Outcomes

Beck Depression Inventory- II

Time Frame: Assessed at every session and at the 1-month follow-up

Secondary Outcomes

  • Behavioral Activation for Depression Scale(Administered at each session and at the 1-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joe Smith

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

University of Maryland, College Park

Study Sites (1)

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