A Computerized Depression Intervention in Veterans
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
endorse any positive symptoms of a psychotic disorder
screen positive for Bipolar I Disorder
report current suicidal risk
Trial design
Design model
Parallel
Treatments tested in this trial
Deprexis
BehavioralDeprexis 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.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: DeprexisExperimental treatment 1 intervention
Group B: Treatment-as-UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Post-Treatment (week 8), Follow-up (week 16)2
World Health Organization Disability Assessment Schedule-II (WHODAS) Change
The World Health Organization Disability Assessment Schedule-II (WHODAS) 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
Time frame
Baseline, Post-Treatment (week 8), Follow-up (week 16)3
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.
Time frame
Baseline, Post-Treatment (week 8), Follow-up (week 16)Sponsors and contacts
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Source ClinicalTrials.gov