Digital Mental Health App Reduces Anxiety but Not Depression in Breast Cancer Survivors

A scalable, publicly available digital mental health treatment (DMHT) program significantly reduced anxiety symptoms—but not depression symptoms—compared with a smartphone-delivered psychoeducation control among breast cancer survivors with elevated psychological distress, according to results of a randomized clinical trial published in JAMA Network Open.¹

In the trial, patients assigned to the DMHT program, delivered through the IntelliCare app suite, reported significantly greater reductions in anxiety symptoms than those assigned to the patient education control (average marginal effect [AME], −1.43; z = −2.65; 95% CI, −2.49 to −0.38; P =.01). The between-group difference in depression symptoms did not reach statistical significance (AME, −0.98; z = −1.89; 95% CI, −1.99 to 0.04; P =.06). Both study groups showed statistically significant within-group reductions in depression and anxiety symptoms from baseline that increased in magnitude over the 12-month follow-up period, with effect sizes (Cohen d) ranging from −0.60 to −1.24.

The trial (NCT04583891) used a Sequential, Multiple Assignment, Randomized Trial (SMART) design and enrolled 313 patients across 44 US states between September 2021 and November 2022, with final data collection in January 2024. Eligible participants were adult women within 5 years of a stage I to III breast cancer diagnosis who had elevated symptoms of depression (Patient Health Questionnaire-8 score ≥10) or anxiety (Generalized Anxiety Disorder-7 score ≥8). Patients were randomized 2:1 to the 8-week DMHT program (n = 209) or an active-control psychoeducation app, Mood Education (n = 104). The primary analysis included 272 participants after exclusions for missing covariate data or nonreceipt of the intervention.

A secondary aim of the trial addressed engagement, a persistent challenge for digital interventions. Within the DMHT group, participants who used the program fewer than 6 days during the first intervention week were classified as having suboptimal engagement and were randomized a second time to receive human coaching starting in week 2 or no additional coaching. Coached participants used the application on significantly more days during the remainder of the intervention than uncoached participants (mean [SD], 27.48 [0.94] vs 24.04 [1.16] days; P =.02), though the difference in number of application sessions was not statistically significant (46.91 [2.73] vs 40.26 [2.91] sessions; P =.10). In a post hoc analysis, coached patients also reported significantly lower depression scores at the 8-week assessment than uncoached patients (mean difference in Patient Health Questionnaire-8 score, −4.12; P <.001), although this difference did not persist at 6 or 12 months. No adverse events were reported during the trial.

The investigators, led by Philip I. Chow, PhD, of the University of Virginia, noted that nearly half of patients diagnosed with breast cancer experience clinically significant depression or anxiety symptoms within the first year after diagnosis, symptoms that can persist for up to 5 years and are associated with reduced quality of life and higher mortality risk.² Limited access to psychotherapists is a major barrier to treatment, and the authors suggested that scalable, low-cost digital interventions like DMHTs may help close this gap, particularly for anxiety symptoms.

The authors cautioned that findings regarding coaching should be interpreted with caution given the limited sample size of the suboptimal-engagement subgroup and noted that the modest, short-lived improvement in engagement and depression scores may not justify the added cost of coaching for all users with early engagement difficulty. They also acknowledged that although coaches were trained not to provide counseling or psychotherapy, common nonspecific elements of therapeutic interaction, such as rapport and empathy, may have occurred during coaching contacts.

Limitations of the trial include a study population that was predominantly White (87.5%) and highly educated (86.2% with a college degree or higher), which may limit generalizability; the absence of a no-treatment or waiting-list control, precluding conclusions about whether either intervention outperforms no treatment; and reliance on self-reported symptom measures rather than structured clinical interviews.

REFERENCES

1. Chow PI, You W, Shaffer KM, et al. Digital mental health treatment and symptoms of depression and anxiety in breast cancer survivors: a randomized clinical trial. JAMA Netw Open. 2026;9(7):e2623871. doi:10.1001/jamanetworkopen.2026.23871

2. Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005;330(7493):702. doi:10.1136/bmj.38343.670868.D3