Testing the Effectiveness of a Computer-based Program for Depression

Major Depressive Disorder Clinical Trial

Official title:

Attention Training for Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203683
• Other study ID #: 2010-09-0004
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2010
• Last updated: October 9, 2013
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Major Depressive Disorder

Exclusion Criteria:

• Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Active computer-based training
8 sessions across 4 weeks.
• Inert computer training
8 sessions across 4 weeks.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory-II	Questionnaire to assess depression symptom severity	Week 4, Week 9	No
Secondary	Structured Clinical Interview for DSM-IV diagnoses	Diagnostic interview to assess for presence of Major depressive disorder (MDD).	Week 9	No
Secondary	Neural processing of emotion stimuli	fMRI paradigm to assess neural changes in how individuals processes emotional stimuli	Week 4	No

External Links

•   Mood Disorders Laboratory at the University of Texas website