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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818453
• Other study ID #: 2013-01-0025
• Status: Completed
• Phase: N/A
• First received: February 20, 2013
• Last updated: November 6, 2015
• Start date: March 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mood Disorders

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16)		Administred every 2 weeks while the participant is engaged in the online deprexis treatment program to measure depression symptom severity.	No
Secondary	Hamilton Depression Rating Scale (HAM-D)		The HAM-D will be completed during the pre- and post-treatment phone interviews to assess depression symptom severity.	No
Secondary	Inventory of Depression and Anxiety Symptoms (IDAS)		The IDAS will be completed as part of the pre- and post-treatment questionnaires to assess for symptoms of depression and anxiety.	No
Secondary	Psychiatric Diagnostic Screening Questionnaire (PDSQ)		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..	No
Secondary	Risky Families Questionnaire (RFQ)		The RFQ will be completed as part of the pre-treatment questionnaires to assess early familial experiences and the harshness of family climate.	No
Secondary	Massachusetts General Hospital Antidepressant Treatment History Questionnaire (ATRQ)		The ATRQ will be administered as part of the pre-treatment questionnaires to evaluate psychotropic efficacy.	No
Secondary	Sheehan Disability Scale (SDS)		The SDS will be completed as part of the pre- and post-treatment questionnaires to evaluate symptom-related disability.	No

External Links

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