A Computerized Depression Intervention in Veterans
Deprexis
A Randomized Controlled Trial of Deprexis; Evaluation of A Computerized Intervention to Decrease Depression and Restore Functioning in Veterans
2 other identifiers
interventional
152
1 country
1
Brief Summary
Depressive symptoms are common among Veterans and associated with significant impairment. Timely intervention has the potential to improve mental health outcomes and restore functioning. Interventions delivered through the internet can be completed remotely at any time, and thus minimize burden on Veterans, however the research examining their utility in Veterans is limited. This proposed project will examine Deprexis, a self-guided internet-delivered intervention, which targets depressive symptoms and associated functional impairments. Interviews will be conducted to gain insight into Veterans' perceptions, needs, and preferences vis-a-vis Deprexis, with results informing a randomized controlled trial. Here an 8-week course of Deprexis will be compared to a treatment-as-usual (TAU) control condition to establish if Deprexis is acceptable and effective for Veterans with mild to moderate depressive symptoms. Veterans engaged in Deprexis are hypothesized to show improvements on measures of functioning and decreases in depressive symptoms compared to the TAU control group. The proposed work has great clinical utility, as it could provide a readily accessible, high-quality intervention for the many Veterans suffering from depressive symptoms, with the potential to improve functioning and long-term outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started May 2024
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
July 14, 2025
July 1, 2025
5 years
January 11, 2024
July 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) Change
The Quick Inventory of Depressive Symptomatology (Self-Report; QIDS-SR-16) is a 16-item self-report measure of depressive symptom severity. This brief measure assesses the 9 DSM-IV symptom criterion domains for depression and has been shown to be highly reliable, internally consistent and sensitive to symptom change. QIDS-SR-16 scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Baseline, Post-Treatment (week 8), Follow-up (week 16)
World Health Organization Disability Assessment Schedule-II (WHODAS) Change
The World Health Organization Disability Assessment Schedule-II (WHODAS32; is a 36-item questionnaire assessing functional disability across 7 domains (understanding and communicating, getting around, getting along with people, life activities, work, participation in society, self-care) as well as a total score. The WHODAS has high test-retest reliability (r=0.98) and concurrent and construct validity. WHODAS scores range from 0 to 100, with higher scores indicating greater disability
Baseline, Post-Treatment (week 8), Follow-up (week 16)
The Sheehan Disability Scale (SDS) Change
The Sheehan Disability Scale (SDS) is a 3-item self-report measure of symptom-related disability, which has been used in previous Deprexis trials. The SDS was developed as a global measure of the impact of mental illness on work/school activities, family relationships and social functioning. The SDS has been found to be internally consistent, reliable and to have high construct validity and to be sensitive to treatment effects. SDS scores range from 0 to 30, with higher scores indicating greater functional impairment.
Baseline, Post-Treatment (week 8), Follow-up (week 16)
Study Arms (2)
Deprexis
EXPERIMENTALDeprexis: an internet-delivered psychosocial treatment for depressive symptoms and related functional impairment.
Treatment-as-Usual
NO INTERVENTIONAccess to standard non-study care
Interventions
Deprexis is an internet-delivered treatment for depressive symptoms and related functional impairment. The intervention draws from various theoretical frameworks and consists of 12 modules: 10 core content modules and an introductory and summary module. Deprexis is designed to be interactive, includes answering questions and learning techniques and concepts through instruction and examples.
Eligibility Criteria
You may qualify if:
- Potential participants include male and female Veterans of all races/ethnicities who are:
- able to comprehend and sign the informed consent form
- have reliable access to the internet and a computer, tablet and/or smartphone
- exhibit mild or moderate, but not very severe, levels of depression
- stable on psychotropic medications
You may not qualify if:
- Aim 1 and Aim 2: Veterans will be excluded from study participation if they:
- endorse any positive symptoms of a psychotic disorder
- screen positive for Bipolar I Disorder
- report current suicidal risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, 76711, United States
Related Publications (1)
Pearson R, Beevers CG, Mignogna J, Benzer J, Pfeiffer PN, Post E, Creech SK. The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 24;13:e59119. doi: 10.2196/59119.
PMID: 39446432DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rahel R Pearson, PhD
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2024
First Posted
January 22, 2024
Study Start
May 1, 2024
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
July 14, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.