Major Depressive DisorderNCT01818453
Can Genetics Predict Treatment Response to a Computerized Self-help Program for Depression?
A study testing Computerized self-help program for depression in people with Major Depressive Disorder and Mood Disorders, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder, Mood Disorders
- What is being tested?
- Computerized self-help program for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Any diagnosis of a psychotic or bipolar disorder
- Meeting for alcohol/drug dependence in the past year
- Having current suicidal risk warranting crisis intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78713
About this study
Official title: Genetic Predictors of 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.
- Conditions
- Major Depressive Disorder, Mood Disorders
- Being tested
- Computerized self-help program for depression
- Keywords
- Mood Disorders, Depression, Genetics, Treatment response, Treatment study
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized self-help program for depressionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR-16)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The ATRQ will be administered as part of the pre-treatment questionnaires to evaluate psychotropic efficacy.
Sheehan Disability Scale (SDS)
Measured: The SDS will be completed as part of the pre- and post-treatment questionnaires to evaluate symptom-related disability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Christopher G. Beevers, University of Texas at Austin
- Investigators
- Christopher G Beevers, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818453
- Sponsor's protocol ID
- 2013-01-0025
- Status last verified
- Nov 2015
- First submitted
- 20 Feb 2013
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28230390
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Predictors of Response to a Computerized Self-help Program for Depression
- ClinicalTrials.gov ID
- NCT01818453
- Acronym / sponsor ID
- 2013-01-0025
- Conditions
- Major Depressive Disorder, Mood Disorders
- Keywords
- Mood Disorders, Depression, Genetics, Treatment response, Treatment study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized self-help program for depression | Active comparator | Behavioral: Computerized self-help program for depressionParticipants will have access to a computerized self-help program for depression, called deprexis, for 8 weeks. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Any diagnosis of a psychotic or bipolar disorder
- Meeting for alcohol/drug dependence in the past year
- Having current suicidal risk warranting crisis intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized self-help program for depressionFor 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. | Behavioural | Computerized self-help program for depression |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- Derived from this study: PubMed 28230390Beevers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher G Beevers, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized self-help program for depression in people with Major Depressive Disorder and Mood Disorders, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.