Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?
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|ClinicalTrials.gov Identifier: NCT01818453|
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : November 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Mood Disorders||Behavioral: Computerized self-help program for depression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Genetic Predictors of Response to a Computerized Self-help Program for Depression|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
- 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. ]
- 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. ]
- 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. ]
- 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.. ]
- 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. ]
- 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. ]
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818453
|United States, Texas|
|The University of Texas at Austin|
|Austin, Texas, United States, 78713|
|Principal Investigator:||Christopher G Beevers, PhD||The University of Texas at Austin|