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Cognitive Control Training for Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Control Training
Peripheral Vision Task
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring Depressed mood

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peripheral Vision Task

Cognitive Control Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Beck Depression Inventory
Change score in BDI was assessed between CCT and PVT groups.

Secondary Outcome Measures

Change in Positive and Negative Affective Scale (PANAS)
We looked at the change scores in positive and negative affectivity between CCT and PVT groups.
Emotional Response and Recovery Task
We looked at the emotional responses to IAPS images between CCT and PVT groups.
Changes in Visual Analog Scales
We looked at the change scores in visual analog scales (happy/sad) between CCT and PVT groups.

Full Information

First Posted
October 13, 2011
Last Updated
October 14, 2011
Sponsor
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT01454141
Brief Title
Cognitive Control Training for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depressed mood

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peripheral Vision Task
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Control Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Control Training
Intervention Description
Three sessions of CCT.
Intervention Type
Other
Intervention Name(s)
Peripheral Vision Task
Intervention Description
Three sessions of PVT.
Primary Outcome Measure Information:
Title
Change in Beck Depression Inventory
Description
Change score in BDI was assessed between CCT and PVT groups.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Affective Scale (PANAS)
Description
We looked at the change scores in positive and negative affectivity between CCT and PVT groups.
Time Frame
two weeks
Title
Emotional Response and Recovery Task
Description
We looked at the emotional responses to IAPS images between CCT and PVT groups.
Time Frame
two weeks
Title
Changes in Visual Analog Scales
Description
We looked at the change scores in visual analog scales (happy/sad) between CCT and PVT groups.
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Cognitive Control Training for Depression

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