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

NCT01694719 | Unknown

• 1 other identifier: 2930
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Major Depressive Disorder; Behavioral Activation; Cognitive Training

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

Secondary Outcomes (1)

• Montgomery Asberg Depression Rating Scale

Other Outcomes (1)

• Ruminative Response Scale

Study Arms (2)

Behavioral Activation + Cognitive Control Training

EXPERIMENTAL

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

Behavioral Activation Therapy plus Control Task

ACTIVE COMPARATOR

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

Interventions

Brief Behavioral Activation Treatment for Depression BEHAVIORAL

Behavioral Activation + Cognitive Control Training; Behavioral Activation Therapy plus Control Task

Cognitive Control Training BEHAVIORAL

Behavioral Activation + Cognitive Control Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-65
• Primary psychiatric diagnosis of major depressive disorder
• Ability to read and speak English sufficiently to complete study procedures
• 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
• Willingness and ability to comply with the requirements of the study protocol

You may not qualify if:

• Lifetime history of bipolar disorder or psychotic disorder
• Neurological disorder such as Parkinson's disease or traumatic brain injury
• Alcohol or substance dependence within the past 6 months
• Substantial suicide risk
• 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
• Current use of antipsychotics, stimulants, or modafinil

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University - Translational Research Program

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Samantha J Moshier, M.A.

CONTACT

617-358-4311; smoshier@bu.edu

Michael W Otto, Ph.D.

CONTACT

617-353-9610; mwotto@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate in Psychology

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

US (1)