Testing the Effectiveness of a Computer-based Program for Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01203683
First received: September 15, 2010
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: Active computer-based training
Behavioral: Inert computer training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Training for Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Beck Depression Inventory-II [ Time Frame: Week 4, Week 9 ] [ Designated as safety issue: No ]
    Questionnaire to assess depression symptom severity


Secondary Outcome Measures:
  • Structured Clinical Interview for DSM-IV diagnoses [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Diagnostic interview to assess for presence of Major depressive disorder (MDD).

  • Neural processing of emotion stimuli [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    fMRI paradigm to assess neural changes in how individuals processes emotional stimuli


Enrollment: 53
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Computer-Based Program
Putatively therapeutic computer program.
Behavioral: Active computer-based training
8 sessions across 4 weeks.
Placebo Comparator: Placebo computer-based program
Inert computer program.
Behavioral: Inert computer training
8 sessions across 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Depressive Disorder

Exclusion Criteria:

  • Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203683

Locations
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Christopher Beevers, PhD University of Texas at Austin
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01203683     History of Changes
Other Study ID Numbers: 2010-09-0004
Study First Received: September 15, 2010
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014