Digitized CBSM interventions demonstrate notable efficacy in reducing cancer-related anxiety and depression: The RESTORE study

Anxiety and depression are prevalent comorbidities among cancer patients, affecting an overall 33% of patients.1 About 70% of cancer patients have experienced various emotional symptoms such as fear of cancer reoccurrence, further intensifying their psychological and financial burden.1 During the ASCO 2023, Ms. Allison Ramiller from Blue Note Therapeutics, the United States (US), presented the practicality of utilizing digitized cognitive behavioral stress management (CBSM) therapy in anxiety and depression prevention.1

The RESTORE study was a two-arm, double-blind, randomized controlled trial that evaluated the efficacy of digitized CBSM therapies as an intervention for physical and mental health issues in adult patients having stage I to III cancers.1 A total of 449 adult stage I-III cancer patients, who had a PROMIS® Anxiety T-score >60 and had been recently treated with their condition within the past 6 months, were recruited and randomized 1:1 into 2 groups, undergoing 10 consecutive digitized CBSM or control therapy sessions for 12 weeks.1 The digitized CBSM group was exposed to a health application containing a variety of interactive CBSM contents that assist them in developing skills for reducing anxiety and depression, while the other in the control group with a health application devoid of the validated CBSM contents.1 Aside from the digital contents, conventional treatments, such as in-person therapy and anti-anxiety medication, were freely available to both of the patient groups.1 Patient-reported outcomes were collected at baseline and every 4 weeks during the 12-week study period.1 The change in PROMIS® Anxiety score over time served as the primary endpoint for this study to determine the efficacy of digitized CBSM in reducing anxiety.1 The secondary endpoints included change in PROMIS® Depression scores over time and Patients’ Global Impression of Change (PGIC) at the end of the study.1

The RESTORE study results indicated that patients in both groups were proactive in using the health applications with no device-related adverse events (AEs) occurred, and that high engagement rates were observed across the 2 groups.1 A significantly greater reduction in anxiety symptoms was observed after 1 CBSM session among patients with stage I to III cancers (p=0.019), and similar results were seen for depression symptoms (p=0.042) over time when compared with control.1 Furthermore, the proportion of patients who deemed their anxiety and depression symptoms as “much” or “very much” improved in the digitized CBSM group was significantly higher (p<0.001), which were twice of that when compared with the control group, highlighting the capability of digital CNSM sessions in promoting positive self-perception for cancer patients.1

In conclusion, digitized CBSM sessions demonstrated remarkable efficacy in minimizing anxiety and depression symptoms among cancer patients, contributing to a reduced risk of moderate-to-severe anxiety or depression.1 Additionally, the digitized CBSM sessions were shown to be safe and could be effective in encouraging patient engagement, which help further promote a positive self-perception for cancer patients.1

  1. Ramiller A, et al. A Cognitive Behavioral Digital Therapeutic for Anxiety and Depression in Patients with Cancer: A Decentralized Randomized Controlled Trial. Presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, June 3, 2023.