Tag: Clinical trial

Background: Depression carries the highest burden of mental health–related disability in the United States. Approximately 13% of military veterans report elevated rates of depression. Despite the availability of evidence-based treatments for depression, nearly 50% of veterans in need of mental health care remain untreated. Internet-based interventions show promise in reducing this gap; however, there are currently no standard self-guided internet-based interventions for depressive symptoms in veterans. Deprexis is one such intervention that leverages cognitive behavioral therapy to target depressive symptoms. Objective: This pilot study evaluated the feasibility, acceptability, and preliminary effectiveness of Deprexis, a fully self-guided internet-based intervention for depression, in US military veterans with mild to severe depressive symptoms. Methods: This open-label pilot trial recruited 19 veterans with mild to severe depression (mean age 55.5, SD 8.2 y; baseline Quick Inventory of Depressive Symptomatology—Self-Report [QIDS-SR]: mean 16.2, SD 4.1) for an 8-week course of Deprexis, with self-report assessments at baseline, posttreatment (8 wk), and follow-up (16 wk). Primary outcomes included depressive symptoms (QIDS-SR), functional disability (World Health Organization Disability Assessment Schedule 2.0), and symptom-related disability (Sheehan Disability Scale). Feasibility was assessed through recruitment and retention rates, and acceptability was measured using validated questionnaires (Credibility and Expectancy Questionnaire and Client Satisfaction Questionnaire). Multilevel models examined change over time, with effect sizes calculated using pooled SDs from unconditional models. Results: Recruitment and retention targets were met, with 15 out of 19 (79%) participants meeting the adherence criteria (ie, ≥60 min of active program use). Of these, 14 participants completed posttreatment questionnaires and were included in the completer analyses. The program received a positive acceptability rating: of the 18 participants who completed follow-up assessments, 78% (n=14) rated services as good or excellent and 72% (n=13) were satisfied with the amount of help received. No safety concerns were reported. Among completers (n=14), QIDS-SR scores decreased from baseline to posttreatment (estimate −2.22, SE 1.44; =.14; =−0.54, 95% CI −1.07 to 0.13) and follow-up (estimate −2.85, SE 1.19; =.02; =−0.70, 95% CI −1.21 to −0.08) with moderate-to-large effect sizes. Effect sizes were similar in the total sample. Functioning (World Health Organization Disability Assessment Schedule 2.0) improved among completers at follow-up (estimate −8.09, SE 3.80; =.045; =−0.41, 95% CI −0.96 to −0.05). Disability (Sheehan Disability Scale) did not significantly improve from baseline to posttreatment or follow-up. Conclusions: This pilot trial demonstrates that Deprexis is feasible and acceptable for veterans with mild to severe depression, with preliminary evidence of effectiveness for depressive symptoms. The delayed emergence of functional improvements and sustained gains at follow-up support the potential of this scalable intervention. The results provide a strong foundation for the ongoing randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT06217198; https://clinicaltrials.gov/study/NCT06217198 International Registered Report Identifier (IRRID): RR2-10.2196/59119
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/70826d4d70665042dcb7552593cb44c1" />