Clinical trial NCT01958840: Evaluating Behavioral Activation Efficacy in Depressed Spanish-Speaking Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Behavioral
Activation
Treatment
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Beck Depression Inventory- II
timeFrame: Assessed at every session and at the 1-month follow-up
Secondary outcomes:
measure: Behavioral Activation for Depression Scale
timeFrame: Administered at each session and at the 1-month follow-up
Other outcomes:
measure: Reward Probability Index
timeFrame: Administered at each session and at the 1-month follow-up
Locations:
city: College Park
country: United States
facility: University of Maryland- College Park
state: Maryland
Study officials:
References:
citation: 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.