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CompletedNCT01958840Updated May 30, 2023

Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos

An interventional study of Behavioral Activation for Depression Treatment and Supportive Counseling in Depression, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-30.

Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

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Keywords

  • Behavioral
  • Activation
  • Treatment
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 46 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Maryland, College Park is the lead sponsor of 60 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Behavioral Activation Treatment for Depression

    Behavioral Activation Condition - 10 sessions

    Behavioral: Behavioral Activation for Depression Treatment

  • Active comparator
    Supportive Counseling

    Supportive Counseling Condition - 10 sessions

    Behavioral: Supportive Counseling

Interventions

  • BehavioralBehavioral Activation for Depression Treatment
  • BehavioralSupportive Counseling
06

What researchers measure

Primary outcomes

  1. Beck Depression Inventory- II

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

Secondary outcomes

  1. Behavioral Activation for Depression Scale

    Time frame: Administered at each session and at the 1-month follow-up

Other outcomes

  1. Reward Probability Index

    Time frame: Administered at each session and at the 1-month follow-up

07

Study locations

1 site
  • University of Maryland- College Park
    College Park, Maryland 20742, United States
08

References and documents

Publications

  • 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. PubMed 24938081 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01958840
Lead sponsor
University of Maryland, College Park
Responsible party
Joe Smith (Director - HRPP (A. Collado is no longer at UMD), University of Maryland, College Park) — Principal investigator
First posted
Oct 9, 2013
Start date
Aug 2013
Primary completion
Oct 2014
Completion
Oct 2014
Last update
May 30, 2023

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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