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Completed

NCT Number: NCT01818453

Can Genetics Predict Treatment 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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized self-help program for depression

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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..

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Brown University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2013
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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