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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014