- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203683
Testing the Effectiveness of a Computer-based Program for Depression
October 9, 2013 updated by: University of Texas at Austin
Attention Training for Major Depressive Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 3
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
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Major Depressive Disorder
Exclusion Criteria:
- Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Computer-Based Program
Putatively therapeutic computer program.
|
8 sessions across 4 weeks.
|
|
Placebo Comparator: Placebo computer-based program
Inert computer program.
|
8 sessions across 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory-II
Time Frame: Week 4, Week 9
|
Questionnaire to assess depression symptom severity
|
Week 4, Week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structured Clinical Interview for DSM-IV diagnoses
Time Frame: Week 9
|
Diagnostic interview to assess for presence of Major depressive disorder (MDD).
|
Week 9
|
|
Neural processing of emotion stimuli
Time Frame: Week 4
|
fMRI paradigm to assess neural changes in how individuals processes emotional stimuli
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Beevers, PhD, University of Texas at Austin
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
January 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
September 15, 2010
First Submitted That Met QC Criteria
September 15, 2010
First Posted (Estimate)
September 16, 2010
Study Record Updates
Last Update Posted (Estimate)
October 10, 2013
Last Update Submitted That Met QC Criteria
October 9, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-09-0004
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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