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

Primary Purpose

Major Depressive Disorder, Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized self-help program for depression
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Mood Disorders, Depression, Genetics, Treatment response, Treatment study

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Computerized self-help program for depression

Wait List Control

Arm Description

Participants will have access to a computerized self-help program for depression, called deprexis, for 8 weeks.

Participants randomly assigned to a "wait list control" condition will wait 8 weeks after assignment before they can access the deprexis program.

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16)

Secondary Outcome Measures

Hamilton Depression Rating Scale (HAM-D)
Inventory of Depression and Anxiety Symptoms (IDAS)
Psychiatric Diagnostic Screening Questionnaire (PDSQ)
Risky Families Questionnaire (RFQ)
Massachusetts General Hospital Antidepressant Treatment History Questionnaire (ATRQ)
Sheehan Disability Scale (SDS)

Full Information

First Posted
February 20, 2013
Last Updated
November 6, 2015
Sponsor
University of Texas at Austin
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01818453
Brief Title
Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?
Official Title
Genetic Predictors of Response to a Computerized Self-help Program for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Brown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Mood Disorders
Keywords
Mood Disorders, Depression, Genetics, Treatment response, Treatment study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computerized self-help program for depression
Arm Type
Active Comparator
Arm Description
Participants will have access to a computerized self-help program for depression, called deprexis, for 8 weeks.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants randomly assigned to a "wait list control" condition will wait 8 weeks after assignment before they can access the deprexis program.
Intervention Type
Behavioral
Intervention Name(s)
Computerized self-help program for depression
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
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.
Title
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..
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher G Beevers, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78713
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28230390
Citation
Beevers CG, Pearson R, Hoffman JS, Foulser AA, Shumake J, Meyer B. Effectiveness of an internet intervention (Deprexis) for depression in a united states adult sample: A parallel-group pragmatic randomized controlled trial. J Consult Clin Psychol. 2017 Apr;85(4):367-380. doi: 10.1037/ccp0000171. Epub 2017 Feb 23.
Results Reference
derived

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

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