NCT01454141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

October 13, 2011

Last Update Submit

October 14, 2011

Conditions

Keywords

Depressed mood

Outcome Measures

Primary Outcomes (1)

  • Change in Beck Depression Inventory

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

    two weeks

Secondary Outcomes (3)

  • Change in Positive and Negative Affective Scale (PANAS)

    two weeks

  • Emotional Response and Recovery Task

    two weeks

  • Changes in Visual Analog Scales

    two weeks

Study Arms (2)

Peripheral Vision Task

EXPERIMENTAL

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.

Other: Peripheral Vision Task

Cognitive Control Training

EXPERIMENTAL

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.

Other: Cognitive Control Training

Interventions

Three sessions of CCT.

Cognitive Control Training

Three sessions of PVT.

Peripheral Vision Task

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BU students and local community members.
  • At least 18 years of age.
  • Familiarity with a computer keyboard.
  • BDI-II score ≥ 17

You may not qualify if:

  • BDI-II score \< 17, or \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

DepressionConsciousness Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 18, 2011

Study Start

July 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations