Proactive Identification and Digital Mental Health Intervention for the Treatment of Depression Among Individuals With Likely Incurable Cancer: A Pilot Randomized Clinical Trial.
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.
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.
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.
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).
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.
ClinicalTrials.gov identifier: NCT05932810.
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.
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.
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).
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.
ClinicalTrials.gov identifier: NCT05932810.
Authors
Graboyes Graboyes, Levins Levins, DeMass DeMass, Baskar Baskar, Natale Natale, Sterba Sterba, Obeid Obeid, Sharma Sharma, Hill Hill, Dahne Dahne
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