Digital Mental Health Treatment and Symptoms of Depression and Anxiety in Breast Cancer Survivors: A Randomized Clinical Trial.

Importance: Psychological distress in breast cancer survivors (BCS) is highly prevalent. Access to treatment is limited by barriers, including a lack of psychotherapists. Objective: To evaluate the efficacy of a scalable, publicly accessible digital mental health treatment (DMHT) for reducing symptoms of depression and anxiety in BCS and the effect of human coaching on engagement among BCS with initially low engagement. Design, Settings, and Participants: This randomized clinical trial followed the SMART (Sequential, Multiple Assignment, Randomized Trial) design and was conducted in the US between September 2021 and January 2024. Adult women who were within 5 years of receiving a breast cancer diagnosis (stage I-III), had a smartphone with a data plan, and had elevated symptoms of depression or anxiety were eligible for inclusion. Participants completed self-reported questionnaires at baseline, 8-week postintervention period, and 6-month and 12-month follow-up periods. Participants were randomized 2:1 to either the DMHT (IntelliCare) or the patient education program. Data analysis was based on intention-to-treat principle. Interventions: The DMHT program is an 8-week self-guided, fully automated suite of 5 clinically focused applications. Participants in the DMHT group were classified as having optimal or suboptimal engagement based on week 1 use. Those with suboptimal engagement were subsequently randomized 1:1 to receive additional coaching or no coaching. The patient education program is an active control condition consisting of 8 weeks of use of a psychoeducational application and no human support. Main Outcomes and Measures: Primary outcomes were symptoms of anxiety (self-assessed using the 7-item Generalized Anxiety Disorder) and depression (self-assessed using the 8-item Patient Health Questionnaire). Secondary outcomes were number of days of application use and number of application sessions. Results: A total of 313 women (mean [SD] age, 51.62 [10.51] years) were enrolled and assigned to the DMHT program (n = 209) or the patient education program (n = 104). Primary analyses included 272 participants. Participants in both DMHT and patient education programs showed significantly reduced symptoms of both depression (Cohen d = -0.60 at the 8-week, -1.03 at the 6-month, and -1.13 at the 12-month assessment) and anxiety (Cohen d = -0.68 at the 8-week, -0.80 at the 6-month, and -0.85 at the 12-month assessment) from baseline. Compared with participants in the patient education group, those in the DMHT group showed significantly greater reductions in symptoms of anxiety (average marginal effect [AME] = -1.43; z = -2.65 [95% CI, -2.49 to -0.38]; P = .01) but not for symptoms of depression (AME = -0.98; z = -1.89 [95% CI, -1.99 to 0.04]; P = .06). Compared with participants with suboptimal engagement who did not receive coaching, those who received coaching used the intervention for a significantly greater number of days (mean [SD], 27.48 [0.94] vs 24.04 [1.16] days; P = .02). Conclusions and Relevance: This randomized trial found that BCS can benefit from a DMHT program, particularly for reducing anxiety. Coaching may promote consistent engagement with a DMHT for those with difficulty engaging initially. Trial Registration: ClinicalTrials.gov Identifier: NCT04583891.