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

Primary Purpose

Depression

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief Behavioral Activation Treatment for Depression

Cognitive Control Training

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder, Behavioral Activation, Cognitive Training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Boston University - Translational Research ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation + Cognitive Control Training

Behavioral Activation Therapy plus Control Task

Arm Description

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.

Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task.

Outcomes

Primary Outcome Measures

Beck Depression Inventory

Secondary Outcome Measures

Montgomery Asberg Depression Rating Scale

Full Information

NCT ID

NCT01694719

First Posted

September 24, 2012

Last Updated

September 26, 2012

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT01694719

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

October 2013 (Anticipated)

Study Completion Date

October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Depression, Major Depressive Disorder, Behavioral Activation, Cognitive Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Behavioral Activation + Cognitive Control Training

Arm Type

Experimental

Arm Description

Arm Title

Behavioral Activation Therapy plus Control Task

Arm Type

Active Comparator

Arm Description

Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task.

Intervention Type

Behavioral

Intervention Name(s)

Brief Behavioral Activation Treatment for Depression

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Control Training

Primary Outcome Measure Information:

Title

Beck Depression Inventory

Secondary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale

Other Pre-specified Outcome Measures:

Title

Ruminative Response Scale

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha J Moshier, M.A.

Phone

617-358-4311

smoshier@bu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Michael W Otto, Ph.D.

Phone

617-353-9610

mwotto@bu.edu

Facility Information:

Facility Name

Boston University - Translational Research Program

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samantha Moshier, M.A.

Phone

617-358-4311

smoshier@bu.edu

12. IPD Sharing Statement

Learn more about this trial

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

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