Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Texas at Austin
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Christopher G. Beevers, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01818453
First received: February 20, 2013
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The goal of this project is to determine whether genetic information can be used to predict response to an internet-based treatment of depression. Several studies now indicate that completing an internet-based treatment for depression, called Deprexis, can significantly improve symptoms of depression. However, not everyone improves. The purpose of this study is to determine whether genetic profile can predict who is likely to improve.


Condition Intervention
Major Depressive Disorder
Mood Disorders
Behavioral: Computerized self-help program for depression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Genetic Predictors of Response to a Computerized Self-help Program for Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16) [ Time Frame: Administred every 2 weeks while the participant is engaged in the online deprexis treatment program to measure depression symptom severity. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: The HAM-D will be completed during the pre- and post-treatment phone interviews to assess depression symptom severity. ] [ Designated as safety issue: No ]
  • Inventory of Depression and Anxiety Symptoms (IDAS) [ Time Frame: The IDAS will be completed as part of the pre- and post-treatment questionnaires to assess for symptoms of depression and anxiety. ] [ Designated as safety issue: No ]
  • Psychiatric Diagnostic Screening Questionnaire (PDSQ) [ Time Frame: The PDSQ will be completed as part of the pre- and post-treatment questionnaires to screen for the most common DSM-IV Axis I disorders.. ] [ Designated as safety issue: No ]
  • Risky Families Questionnaire (RFQ) [ Time Frame: The RFQ will be completed as part of the pre-treatment questionnaires to assess early familial experiences and the harshness of family climate. ] [ Designated as safety issue: No ]
  • Massachusetts General Hospital Antidepressant Treatment History Questionnaire (ATRQ) [ Time Frame: The ATRQ will be administered as part of the pre-treatment questionnaires to evaluate psychotropic efficacy. ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) [ Time Frame: The SDS will be completed as part of the pre- and post-treatment questionnaires to evaluate symptom-related disability. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Computerized self-help program for depression
Participants will have access to a computerized self-help program for depression, called deprexis, for 8 weeks.
Behavioral: Computerized self-help program for depression
For 8 weeks, participants will engage in a computerized self-help program for depression, called deprexis. This program consists of 10 content modules representing different psychotherapeutic approaches broadly consistent with a cognitive-behavioral perspective. Modules are organized as simulated dialogues in which the program explains and illustrates concepts and techniques, engages the user in exercises, and continuously asks users to respond by selecting from response options. Subsequent content is then tailored to the users' responses, resulting in a simulated conversational flow. Participants can access the self-help program as often as they would like and since it is self-guided, they will determine how often they access the material. Each module can be completed in 10 to 60 minutes, depending on the user's reading speed, interest, motivation, and individual path through the program.
No Intervention: Wait List Control
Participants randomly assigned to a "wait list control" condition will wait 8 weeks after assignment before they can access the deprexis program.

  Eligibility

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

Inclusion Criteria:

  • English-speaking
  • Have reliable access to the internet (i.e., dialup or broadband access)
  • Be willing to donate saliva for DNA research
  • Have a current symptoms of depression
  • Be stable on medication and/or therapy (i.e. no changes within 2 weeks of study entry)

Exclusion Criteria:

  • Any diagnosis of a psychotic or bipolar disorder
  • Meeting for alcohol/drug dependence in the past year
  • Having current suicidal risk warranting crisis intervention
  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: NCT01818453

Contacts
Contact: Rahel Pearson, MA 512-471-6120 deprexis@utexas.edu

Locations
United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78713
Principal Investigator: Christopher G Beevers, Ph.D.         
Sub-Investigator: Kari Nations, Ph.D.         
Sub-Investigator: Rahel Pearson, MA         
Sponsors and Collaborators
University of Texas at Austin
Brown University
Investigators
Principal Investigator: Christopher G Beevers, PhD The University of Texas at Austin
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher G. Beevers, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01818453     History of Changes
Other Study ID Numbers: 2013-01-0025
Study First Received: February 20, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Mood Disorders
Depression
Genetics
Treatment response
Treatment study

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

ClinicalTrials.gov processed this record on October 23, 2014