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

November 6, 2015 updated by: Christopher G. Beevers, University of Texas at Austin

Genetic Predictors of Response to a Computerized Self-help Program for Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

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

  • United States
    • Texas
      • Austin, Texas, United States, 78713
        • The 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:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Administred every 2 weeks while the participant is engaged in the online deprexis treatment program to measure depression symptom severity.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
The HAM-D will be completed during the pre- and post-treatment phone interviews to assess depression symptom severity.
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.
The IDAS will be completed as part of the pre- and post-treatment questionnaires to assess for symptoms of depression and anxiety.
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..
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..
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.
The RFQ will be completed as part of the pre-treatment questionnaires to assess early familial experiences and the harshness of family climate.
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.
The ATRQ will be administered as part of the pre-treatment questionnaires to evaluate psychotropic efficacy.
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.
The SDS will be completed as part of the pre- and post-treatment questionnaires to evaluate symptom-related disability.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Brown University

Investigators

  • Principal Investigator: Christopher G Beevers, PhD, The University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-01-0025

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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