Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial.

Autor: Zion SR; Blue Note Therapeutics, San Francisco, CA., Taub CJ; Blue Note Therapeutics, San Francisco, CA., Heathcote LC; King's College London, London, United Kingdom., Ramiller A; Blue Note Therapeutics, San Francisco, CA., Tinianov S; Blue Note Therapeutics, San Francisco, CA., McKinley M; Blue Note Therapeutics, San Francisco, CA., Eich G; Blue Note Therapeutics, San Francisco, CA., Penedo FJ; University of Miami, Coral Gables, FL., Ganz PA; University of California Los Angeles, Los Angeles, CA., Antoni M; University of Miami, Coral Gables, FL., Shumay DM; Blue Note Therapeutics, San Francisco, CA.; University of California San Francisco, San Francisco, CA.
Jazyk: angličtina
Zdroj: JCO oncology practice [JCO Oncol Pract] 2023 Dec; Vol. 19 (12), pp. 1179-1189. Date of Electronic Publication: 2023 Oct 20.
DOI: 10.1200/OP.23.00210
Abstrakt: Purpose: Patients with cancer often experience elevated levels of distress. This double-blind, randomized controlled trial compared the impact of an app-based version of cognitive behavioral stress management (CBSM) versus a health education sham app on anxiety and depression symptoms.
Methods: Patients with nonmetastatic (stage I-III) cancer who were receiving or recently completed (≤6 months) systemic treatment were recruited nationwide. The primary outcome of change in anxiety symptoms (PROMIS-Anxiety) over 12 weeks and the top secondary outcome of change in depression symptoms (PROMIS-Depression) over 12 weeks were analyzed using mixed-effects modeling with repeated measures (weeks 0, 4, 8, 12). Patient global impressions of change in anxiety and depression were reported at weeks 4, 8, and 12. In addition, self-reported adverse events were collected throughout the study and adjudicated by the site principal investigator.
Results: Four hundred forty-nine patients were enrolled in the trial (age M [standard deviation] = 52.44 [11.46]; 81% female; 76% White; 53% breast cancer). Patients randomly assigned to digitized CBSM showed significantly greater reductions in anxiety ( B = -0.03; P = .019) and depression ( B = -0.02; P = .042) symptoms over 12 weeks. Patients who received digitized CBSM were also significantly more likely to perceive much or very much improvement ( v no/minimal change or much/very much worse) in their symptoms of anxiety (χ 2 = 31.76; P < .001) and depression (χ 2 = 19.70; P < .001) compared with the control.
Conclusion: The use of digitized CBSM led to significant improvements in anxiety and depression outcomes compared with the sham app.
Databáze: MEDLINE