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Completed

NCT Number: NCT01958840

Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland- College Park

College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Activation for Depression Treatment

Behavioral

Supportive Counseling

Behavioral

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

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2013
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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