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Proactive Identification and Digital Mental Health Intervention for the Treatment of Depression Among Individuals With Likely Incurable Cancer: A Pilot Randomized Clinical Trial

Psychooncology. 2025 Oct;34(10):e70309. doi: 10.1002/pon.70309.

ABSTRACT

BACKGROUND: Although depression is prevalent and has significant consequences among individuals living with likely incurable cancer (ILLIC), optimal methods of identifying and treating depression in this population remain unknown.

AIMS: To evaluate a paradigm of (1) proactive identification (ID) (i.e., remotely and asynchronously from clinical encounters) of depression among ILLIC and (2) digital mental health intervention (DMHI) for depression treatment.

METHODS: In this decentralized randomized clinical trial, ILLIC with elevated depressive symptoms were proactively identified using electronic health record data and randomized 2:1 to a DMHI-based Behavioral Activation treatment or usual care (UC) depression treatment. Measures of feasibility (accrual, retention) and acceptability (engagement) were described; depression severity (change in PHQ-9 scores through 4 weeks post-randomization) was modeled with a generalized estimating equation.

RESULTS: Among 88 ILLIC who completed screening, 30 were eligible and randomized to the trial. No patients were lost to follow-up or withdrew; 80% of patients randomized to proactive ID + DMHI used the app through 4 weeks. Proactive ID + DMHI improved depression from baseline to 4 weeks relative to proactive ID + UC (mean difference in change from baseline to week 4 = -2.7; 90% CI: -4.9 to -0.4). At 4 weeks, the odds of a clinical response (PHQ-9 decrease of ≥ 5 points) was 9.0-fold higher for patients in proactive ID + DMHI relative to proactive ID + UC (OR 9.0; 90% CI: 1.1-74.2).

CONCLUSIONS: A proactive ID + DMHI approach to identifying and treating depression among ILLIC is feasible, acceptable, and potentially efficacious. These promising data support conducting a large efficacy trial evaluating this approach.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05932810.

PMID:41125447 | DOI:10.1002/pon.70309