Results from the RESTORE study indicate that a cognitive behavioral stress management app improves symptoms of anxiety and depression.
Positive changes were observed when patients with cancer used a cognitive behavioral stress management (CBSM) app to help with anxiety and depression, according to results from the RESTORE study (NCT05227898) presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Digital therapeutics,” study authors wrote, “have the potential to improve access to empirically supported psychological treatments for symptoms of anxiety and depression in patients with cancer.”
The RESTORE study from biotech company Blue Note Therapeutics — the results of which were presented by co-author Allison Ramiller — was a 12-week, double-blind, randomized, controlled trial comparing the impact of Attune, a CBSM app designed to be used alongside usual medical and psychosocial oncology care regimens, against that of Cerena, a health education control app described by the authors as a “functionally similar sham app.”
Patients using both Attune and Cerena each completed 10 informational sessions that were approximately 1 hour long, and both apps included guided exercises and other interactive opportunities, according to clinicaltrials.gov.
The 449 participating patients with non-metastatic stage I, II, and III hematological cancers were receiving systemic treatment such as radiation, chemotherapy or immunotherapy, had completed treatment within the last six months or had an established treatment plan including systemic treatment and had reported a score of more than 60 on the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety (PROMIS-A) scale, according to the study and its listing on clinicaltrials.gov.
The pre-specified primary outcome researchers were looking for was a change in anxiety symptoms measured at the start and at weeks 4, 8, and 12. Secondary outcomes included: changes in symptoms of depression (PROMIS-D) and emotional distress; cancer-related symptoms of anxiety; wellbeing and quality of life; symptom-related stress; perceived stress; level of stress management skill and coping skill efficacy; product usability, safety and acceptability; and the global impression of change (patients’ believe in a treatment’s effectiveness) in anxiety and depression. (PGI-C).
Participating patients were 80.6% female, 76.5% white and the mean age was 52.44 (range, 25-80) years. Compared to the patients in the Cerena control group, participants using Attune had greater reductions in anxiety (p=0.019) and depression (p=0.042) symptoms over 12 weeks, according to the study findings.
By the end of the 12-week study, there was a greater proportion of Attune participants in the PROMIS-A (p=0.004) and PROMIS-D (p=0.035) mild-none symptom severity category, the authors wrote, also noting that there were “significant group differences in PGI-C, as patients using Attune were more likely to report much or very much improvement in their anxiety (P <0.001) and depression symptoms (P <0.001).” This, per the study’s authors, is an indication of “clinically meaningful change.”
A third of patients with cancer, Ramiller said, are diagnosed with comorbid anxiety and depression, while 7 out of 10 suffer distressing emotional symptoms, including fear of recurrence. This added burden increases financial costs for patients by $12 billion each year.
“There are currently 18 million cancer patients and survivors living in the United States,” she said. “Most lack access to psycho-oncology care. With statistics like these, it's clear that anxiety and depression have a huge impact.”
Access is a problem, according to Ramiller, with not enough qualified, trained providers to meet the need and patients encountering barriers to in-person help including transportation or financial issues.
A digitized, evidence-based intervention, she explained, could both broaden access to quality therapeutic content and allow the limited pool of cancer-specific mental health providers to focus on more complex cases.
Looking ahead, Ramiller noted that there is a study currently in progress looking at the six-month post-intervention time point. More research is needed to “understand what engagement and effectiveness would look like in real world settings” and to directly test potential cost savings of digitized CBSM.
Zion SR, Taub CJ, Heathcote LC, et al. A cognitive behavioral digital therapeutic for anxiety and depression in patients with cancer: A decentralized randomized controlled trial. J Clin Oncol. 2023;41(suppl_16):1507.doi: 10.1200/JCO.2023.41.16_suppl.1507