Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Samantha Moshier, M.A., Boston University
ClinicalTrials.gov Identifier:
NCT01694719
First received: September 24, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the potential effects of a cognitive training program when combined with a particular form of psychotherapy (behavioral activation therapy) for depression. Behavioral activation therapy targets changes in behavior as a method for improving a depressed individual's thoughts, feelings, and overall quality of life. This study is designed to test whether a computerized brain exercise called cognitive control training can enhance the effects of a 5-session behavioral activation therapy program. CCT has been shown to reduce depressive symptoms in two other studies, but it has not yet been combined with behavioral activation therapy. The investigators hypothesize that individuals assigned to the behavioral activation plus cognitive control training condition will demonstrate reduced depressive symptoms from pre to post treatment compared with those assigned to the behavioral activation plus computerized control condition. The investigators hypothesize that these gains will be maintained at one-month follow up.


Condition Intervention
Depression
Behavioral: Brief Behavioral Activation Treatment for Depression
Behavioral: Cognitive Control Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Beck Depression Inventory

Secondary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale

Other Outcome Measures:
  • Ruminative Response Scale [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: September 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Activation + Cognitive Control Training
Participants will receive 5 sessions of behavioral activation therapy concurrent with 4 sessions of cognitive control training, a computerized intervention which targets cognitive control processes such as working memory and attention.
Behavioral: Brief Behavioral Activation Treatment for Depression Behavioral: Cognitive Control Training
Active Comparator: Behavioral Activation Therapy plus Control Task
Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task.
Behavioral: Brief Behavioral Activation Treatment for Depression

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults ages 18-65
  2. Primary psychiatric diagnosis of major depressive disorder
  3. Ability to read and speak English sufficiently to complete study procedures
  4. If taking antidepressant or anxiolytic medication, participants must be taking a stabilized dose for a minimum period of at least 8 weeks prior to entry into the study
  5. Willingness and ability to comply with the requirements of the study protocol

Exclusion Criteria:

  1. Lifetime history of bipolar disorder or psychotic disorder
  2. Neurological disorder such as Parkinson's disease or traumatic brain injury
  3. Alcohol or substance dependence within the past 6 months
  4. Substantial suicide risk
  5. Concurrent psychotherapy initiated within 2 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the depression other than general supportive therapy
  6. Current use of antipsychotics, stimulants, or modafinil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694719

Contacts
Contact: Samantha J Moshier, M.A. 617-358-4311 smoshier@bu.edu
Contact: Michael W Otto, Ph.D. 617-353-9610 mwotto@bu.edu

Locations
United States, Massachusetts
Boston University - Translational Research Program Recruiting
Boston, Massachusetts, United States, 02215
Contact: Samantha Moshier, M.A.    617-358-4311    smoshier@bu.edu   
Sponsors and Collaborators
Boston University
  More Information

No publications provided

Responsible Party: Samantha Moshier, M.A., Doctoral Candidate in Psychology, Boston University
ClinicalTrials.gov Identifier: NCT01694719     History of Changes
Other Study ID Numbers: 2930
Study First Received: September 24, 2012
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Depression
Major Depressive Disorder
Behavioral Activation
Cognitive Training

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014