NCT01958840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

October 7, 2013

Last Update Submit

May 25, 2023

Conditions

Keywords

BehavioralActivationTreatment

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory- II

    Assessed at every session and at the 1-month follow-up

Secondary Outcomes (1)

  • Behavioral Activation for Depression Scale

    Administered at each session and at the 1-month follow-up

Other Outcomes (1)

  • Reward Probability Index

    Administered at each session and at the 1-month follow-up

Study Arms (2)

Behavioral Activation Treatment for Depression

EXPERIMENTAL

Behavioral Activation Condition - 10 sessions

Behavioral: Behavioral Activation for Depression Treatment

Supportive Counseling

ACTIVE COMPARATOR

Supportive Counseling Condition - 10 sessions

Behavioral: Supportive Counseling

Interventions

Behavioral Activation Treatment for Depression
Supportive Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland- College Park

College Park, Maryland, 20742, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionBehavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - HRPP (A. Collado is no longer at UMD)

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations