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

Sean R. Zion; Chloe J. Taub; Lauren C. Heathcote; Allison Ramiller; Stacey Tinianov; Michael McKinley; Geoff Eich; Frank J. Penedo; Patricia A. Ganz; Michael Antoni; Dianne M. Shumay

doi:10.1200/OP.23.00210

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

Sean R. Zion, Chloe J. Taub, Lauren C. Heathcote, Allison Ramiller, Stacey Tinianov, Michael McKinley, Geoff Eich, Frank J. Penedo, Patricia A. Ganz, Michael Antoni, Dianne M. Shumay

Psychology

Blue Note Therapeutics
1Department of Hepatology, Imperial College London, London, UK. 2Institute of Liver Studies at King's College School of Medicine at King's College Hospital, London, UK. 3Institute of Human Health and Performance, University College London, London, UK. 4Department of Asthma Allergy and Lung Biology, King's College London, London, UK. 5Division of Critical Care Medicine, University of Alberta, Edmonton, Canada.
University of Miami Brain Endowment Bank, Miami, FL, 33136, USA.
Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, CA 90095, USA; Dept. of Psychology, University of California, Los Angeles, CA 90095, USA; Brain Research Institute, University of California, Los Angeles, CA 90095, USA.

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

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 ( Β = -0.03; P = .019) and depression ( Β = -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 ( ν no/minimal change or much/very much worse) in their symptoms of anxiety (χ2 = 31.76; P < .001) and depression (χ2 = 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.

Original language	English
Pages (from-to)	1179-1189
Number of pages	11
Journal	JCO oncology practice
Volume	19
Issue number	12
Early online date	20 Oct 2023
DOIs	https://doi.org/10.1200/OP.23.00210
Publication status	Published - 1 Dec 2023

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Zion, S. R., Taub, C. J., Heathcote, L. C., Ramiller, A., Tinianov, S., McKinley, M., Eich, G., Penedo, F. J., Ganz, P. A., Antoni, M., & Shumay, D. M. (2023). Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial. JCO oncology practice, 19(12), 1179-1189. https://doi.org/10.1200/OP.23.00210

@article{72d3d770a747492a9e9012cdd9736f66,

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

abstract = "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 ( Β = -0.03; P = .019) and depression ( Β = -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 ( ν no/minimal change or much/very much worse) in their symptoms of anxiety (χ2 = 31.76; P < .001) and depression (χ2 = 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.",

author = "Zion, {Sean R.} and Taub, {Chloe J.} and Heathcote, {Lauren C.} and Allison Ramiller and Stacey Tinianov and Michael McKinley and Geoff Eich and Penedo, {Frank J.} and Ganz, {Patricia A.} and Michael Antoni and Shumay, {Dianne M.}",

note = "Publisher Copyright: {\textcopyright} American Society of Clinical Oncology.",

year = "2023",

month = dec,

day = "1",

doi = "10.1200/OP.23.00210",

language = "English",

volume = "19",

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Zion, SR, Taub, CJ, Heathcote, LC, Ramiller, A, Tinianov, S, McKinley, M, Eich, G, Penedo, FJ, Ganz, PA, Antoni, M & Shumay, DM 2023, 'Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer: A Randomized Controlled Trial', JCO oncology practice, vol. 19, no. 12, pp. 1179-1189. https://doi.org/10.1200/OP.23.00210

TY - JOUR

T1 - Effects of a Cognitive Behavioral Digital Therapeutic on Anxiety and Depression Symptoms in Patients With Cancer

T2 - A Randomized Controlled Trial

AU - Zion, Sean R.

AU - Taub, Chloe J.

AU - Heathcote, Lauren C.

AU - Ramiller, Allison

AU - Tinianov, Stacey

AU - McKinley, Michael

AU - Eich, Geoff

AU - Penedo, Frank J.

AU - Ganz, Patricia A.

AU - Antoni, Michael

AU - Shumay, Dianne M.

PY - 2023/12/1

Y1 - 2023/12/1

N2 - 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 ( Β = -0.03; P = .019) and depression ( Β = -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 ( ν no/minimal change or much/very much worse) in their symptoms of anxiety (χ2 = 31.76; P < .001) and depression (χ2 = 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.

AB - 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 ( Β = -0.03; P = .019) and depression ( Β = -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 ( ν no/minimal change or much/very much worse) in their symptoms of anxiety (χ2 = 31.76; P < .001) and depression (χ2 = 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.

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U2 - 10.1200/OP.23.00210

DO - 10.1200/OP.23.00210

M3 - Article

C2 - 37862670

SN - 2688-1535

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SP - 1179

EP - 1189

JO - JCO oncology practice

JF - JCO oncology practice

IS - 12

ER -

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

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