- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454141
Cognitive Control Training for Depression
October 14, 2011 updated by: Boston University
Depression is frequently characterized by patterns of inflexible, maladaptive, and ruminative thinking styles; these patterns themselves are thought to result from a combination of decreased attentional control, decreased executive functioning, and increased negative affect.
Specifically, the dorsolateral prefrontal cortex has been hypothesized to play a central role in emotion regulation by recruiting resources necessary for executive control.
Recent advances have been made in neurobehavioral training strategies as interventions for emotional disorders such as depression.
Cognitive control training (CCT) uses computer-based exercises to recruit and activate prefrontal neural networks via repeated behavioral exercises, with the aim of strengthening cognitive and emotional functions.
A previous study found that severely depressed participants who received CCT exhibited reduced negative affect and rumination as well as improved focus and concentration.
The present study aimed to extend this line of research by employing a more stringent control group and testing the efficacy of three sessions of CCT over a two-week period in a community population with depressed mood.
Forty-eight participants with high BDI-II scores were randomized to CCT or a comparison condition (Peripheral Vision Training; PVT).
The investigators hypothesized that relative to a control condition (PVT), CCT would be associated with less self-reported negative mood and emotional reactivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Boston University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BU students and local community members.
- At least 18 years of age.
- Familiarity with a computer keyboard.
- BDI-II score ≥ 17
Exclusion Criteria:
- BDI-II score < 17, or > 35
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peripheral Vision Task
During this task participants viewed a circular array of 15 discs and were asked to move their attention, but not their eyes, clockwise around the array while auditory tones were presented.
Following the presentation of a distinct target tone, the discs changed color and participants reported the color of the disc by pressing a designated button on the keyboard.
This task was developed to be a non-active control condition, targeting visual and occipital areas of the brain, and therefore allows us to discriminate between the effects of completing a computer-based task from interventions that specifically target the PFC.
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Three sessions of PVT.
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Experimental: Cognitive Control Training
Cognitive Control Training (CCT) A modified version of the Paced Auditory Serial Addition Task (PASAT) and the Attention Control Intervention were used to train participants' attentional control in accordance with procedures used by Siegle and colleagues.
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Three sessions of CCT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Depression Inventory
Time Frame: two weeks
|
Change score in BDI was assessed between CCT and PVT groups.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Positive and Negative Affective Scale (PANAS)
Time Frame: two weeks
|
We looked at the change scores in positive and negative affectivity between CCT and PVT groups.
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two weeks
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Emotional Response and Recovery Task
Time Frame: two weeks
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We looked at the emotional responses to IAPS images between CCT and PVT groups.
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two weeks
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Changes in Visual Analog Scales
Time Frame: two weeks
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We looked at the change scores in visual analog scales (happy/sad) between CCT and PVT groups.
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two weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
October 13, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 18, 2011
Last Update Submitted That Met QC Criteria
October 14, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BU-2182E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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