NCT01818453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

February 20, 2013

Last Update Submit

November 6, 2015

Conditions

Keywords

Mood DisordersDepressionGeneticsTreatment responseTreatment study

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (6)

  • 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.

  • 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.

  • 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..

  • 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.

  • Massachusetts General Hospital Antidepressant Treatment History Questionnaire (ATRQ)

    The ATRQ will be administered as part of the pre-treatment questionnaires to evaluate psychotropic efficacy.

  • +1 more secondary outcomes

Study Arms (2)

Computerized self-help program for depression

ACTIVE COMPARATOR

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

Behavioral: Computerized self-help program for depression

Wait List Control

NO INTERVENTION

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

Interventions

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.

Computerized self-help program for depression

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78713, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depressive Disorder, MajorMood DisordersDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Christopher G Beevers, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2013

First Posted

March 26, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations