Suspended

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

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What is being tested

Brief Behavioral Activation Treatment for Depression

+ Cognitive Control Training

+ Brief Behavioral Activation Treatment for Depression

Behavioral
Who is being recruted

Behavior+4

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorBoston University
Study ContactSamantha J Moshier, M.A.More contacts
Last updated: September 27, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01694719
Principal SponsorBoston University
Study ContactSamantha J Moshier, M.A.More contacts
Last updated: September 27, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsDepressive DisorderMood DisordersDepressionDepressive Disorder, Major

Criteria

5 inclusion criteria required to participate
Ability to read and speak English sufficiently to complete study procedures
Adults ages 18-65
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
Primary psychiatric diagnosis of major depressive disorder
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6 exclusion criteria prevent from participating
Alcohol or substance dependence within the past 6 months
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
Lifetime history of bipolar disorder or psychotic disorder
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Boston University - Translational Research Program

Boston, United StatesOpen Boston University - Translational Research Program in Google Maps
SuspendedOne Study Center