Back to resultsTesting the Effectiveness of a Computer-based Program for Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Active computer-based training
Inert computer training
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression
Eligibility Criteria
Inclusion Criteria:
- Major Depressive Disorder
Exclusion Criteria:
- Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Computer-Based Program
Placebo computer-based program
Arm Description
Putatively therapeutic computer program.
Inert computer program.
Outcomes
Primary Outcome Measures
Beck Depression Inventory-II
Questionnaire to assess depression symptom severity
Secondary Outcome Measures
Structured Clinical Interview for DSM-IV diagnoses
Diagnostic interview to assess for presence of Major depressive disorder (MDD).
Neural processing of emotion stimuli
fMRI paradigm to assess neural changes in how individuals processes emotional stimuli
Full Information
NCT ID
NCT01203683
First Posted
September 15, 2010
Last Updated
October 9, 2013
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT01203683
Brief Title
Testing the Effectiveness of a Computer-based Program for Depression
Official Title
Attention Training for Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Computer-Based Program
Arm Type
Experimental
Arm Description
Putatively therapeutic computer program.
Arm Title
Placebo computer-based program
Arm Type
Placebo Comparator
Arm Description
Inert computer program.
Intervention Type
Behavioral
Intervention Name(s)
Active computer-based training
Intervention Description
8 sessions across 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Inert computer training
Intervention Description
8 sessions across 4 weeks.
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II
Description
Questionnaire to assess depression symptom severity
Time Frame
Week 4, Week 9
Secondary Outcome Measure Information:
Title
Structured Clinical Interview for DSM-IV diagnoses
Description
Diagnostic interview to assess for presence of Major depressive disorder (MDD).
Time Frame
Week 9
Title
Neural processing of emotion stimuli
Description
fMRI paradigm to assess neural changes in how individuals processes emotional stimuli
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Depressive Disorder
Exclusion Criteria:
Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Beevers, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Testing the Effectiveness of a Computer-based Program for Depression
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