Chloe J Taub, Sean R Zion, Molly Ream, Allison Ramiller, Lauren C Heathcote, Geoff Eich, Meridithe Mendelsohn, Justin Birckbichler, Patricia A Ganz, David Cella, Frank J Penedo, Michael Antoni, Dianne M Shumay
{"title":"认知行为数字治疗对癌症患者痛苦和生活质量的影响：国家随机对照试验。","authors":"Chloe J Taub, Sean R Zion, Molly Ream, Allison Ramiller, Lauren C Heathcote, Geoff Eich, Meridithe Mendelsohn, Justin Birckbichler, Patricia A Ganz, David Cella, Frank J Penedo, Michael Antoni, Dianne M Shumay","doi":"10.1037/ccp0000911","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Cancer-specific psychological interventions like cognitive behavioral stress management (CBSM) demonstrate distress (e.g., anxiety/depression) and quality of life (QoL) benefits. Digital formats can expand access.</p><p><strong>Method: </strong>Patients (80.6% female; 76.5% White; 25-80 years) with Stage I-III cancer and elevated anxiety within 6 months of treatment (surgery/chemotherapy/radiation/immunotherapy) receipt were randomized 1:1 to a 10-module CBSM or health education control digital app and completed questionnaires at Weeks 0, 4, 8, 12. Primary outcomes of greater group-level anxiety (PROMIS-A) and depression symptom (PROMIS-D) reductions for CBSM were met and published; this secondary report evaluates individual-level response results for these outcomes and outcomes beyond anxiety and depression. Chi-square tests compared responder proportions using PROMIS-A/PROMIS-D symptom categories and two levels (≥5/≥7.5) of T-score point reductions. Changes across conditions over time for stress (Perceived Stress Scale), cancer-specific distress (Impact of Event Scale-Intrusions), and QoL (Functional Assessment of Cancer Therapy-General) were analyzed using repeated measures linear mixed-effects modeling (N = 449). Patient Global Impression of Change-Well-being was also examined.</p><p><strong>Results: </strong>At Week 12, a greater proportion of CBSM (vs. control) participants reported normal-to-mild (vs. moderate-to-severe) PROMIS-A and PROMIS-D, and a greater proportion of CBSM participants at Week 8 or 12 had a ≥7.5 T-score reduction in PROMIS-A and a ≥5 T-score reduction in PROMIS-D (ps < .05). CBSM participants (vs. control) showed significantly greater reductions in Perceived Stress Scale and Impact of Event Scale-Intrusions and increases in Patient Global Impression of Change-Well-being and Functional Assessment of Cancer Therapy emotional and physical well-being (ps < .05), but not functional or social/family well-being.</p><p><strong>Conclusion: </strong>Digitized CBSM benefits distress and QoL. (PsycInfo Database Record (c) 2024 APA, all rights reserved).</p>","PeriodicalId":15447,"journal":{"name":"Journal of consulting and clinical psychology","volume":"92 11","pages":"727-741"},"PeriodicalIF":4.5000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial.\",\"authors\":\"Chloe J Taub, Sean R Zion, Molly Ream, Allison Ramiller, Lauren C Heathcote, Geoff Eich, Meridithe Mendelsohn, Justin Birckbichler, Patricia A Ganz, David Cella, Frank J Penedo, Michael Antoni, Dianne M Shumay\",\"doi\":\"10.1037/ccp0000911\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Cancer-specific psychological interventions like cognitive behavioral stress management (CBSM) demonstrate distress (e.g., anxiety/depression) and quality of life (QoL) benefits. Digital formats can expand access.</p><p><strong>Method: </strong>Patients (80.6% female; 76.5% White; 25-80 years) with Stage I-III cancer and elevated anxiety within 6 months of treatment (surgery/chemotherapy/radiation/immunotherapy) receipt were randomized 1:1 to a 10-module CBSM or health education control digital app and completed questionnaires at Weeks 0, 4, 8, 12. Primary outcomes of greater group-level anxiety (PROMIS-A) and depression symptom (PROMIS-D) reductions for CBSM were met and published; this secondary report evaluates individual-level response results for these outcomes and outcomes beyond anxiety and depression. Chi-square tests compared responder proportions using PROMIS-A/PROMIS-D symptom categories and two levels (≥5/≥7.5) of T-score point reductions. Changes across conditions over time for stress (Perceived Stress Scale), cancer-specific distress (Impact of Event Scale-Intrusions), and QoL (Functional Assessment of Cancer Therapy-General) were analyzed using repeated measures linear mixed-effects modeling (N = 449). Patient Global Impression of Change-Well-being was also examined.</p><p><strong>Results: </strong>At Week 12, a greater proportion of CBSM (vs. control) participants reported normal-to-mild (vs. moderate-to-severe) PROMIS-A and PROMIS-D, and a greater proportion of CBSM participants at Week 8 or 12 had a ≥7.5 T-score reduction in PROMIS-A and a ≥5 T-score reduction in PROMIS-D (ps < .05). CBSM participants (vs. control) showed significantly greater reductions in Perceived Stress Scale and Impact of Event Scale-Intrusions and increases in Patient Global Impression of Change-Well-being and Functional Assessment of Cancer Therapy emotional and physical well-being (ps < .05), but not functional or social/family well-being.</p><p><strong>Conclusion: </strong>Digitized CBSM benefits distress and QoL. (PsycInfo Database Record (c) 2024 APA, all rights reserved).</p>\",\"PeriodicalId\":15447,\"journal\":{\"name\":\"Journal of consulting and clinical psychology\",\"volume\":\"92 11\",\"pages\":\"727-741\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of consulting and clinical psychology\",\"FirstCategoryId\":\"102\",\"ListUrlMain\":\"https://doi.org/10.1037/ccp0000911\",\"RegionNum\":1,\"RegionCategory\":\"心理学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHOLOGY, CLINICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of consulting and clinical psychology","FirstCategoryId":"102","ListUrlMain":"https://doi.org/10.1037/ccp0000911","RegionNum":1,"RegionCategory":"心理学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHOLOGY, CLINICAL","Score":null,"Total":0}
Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial.
Objective: Cancer-specific psychological interventions like cognitive behavioral stress management (CBSM) demonstrate distress (e.g., anxiety/depression) and quality of life (QoL) benefits. Digital formats can expand access.
Method: Patients (80.6% female; 76.5% White; 25-80 years) with Stage I-III cancer and elevated anxiety within 6 months of treatment (surgery/chemotherapy/radiation/immunotherapy) receipt were randomized 1:1 to a 10-module CBSM or health education control digital app and completed questionnaires at Weeks 0, 4, 8, 12. Primary outcomes of greater group-level anxiety (PROMIS-A) and depression symptom (PROMIS-D) reductions for CBSM were met and published; this secondary report evaluates individual-level response results for these outcomes and outcomes beyond anxiety and depression. Chi-square tests compared responder proportions using PROMIS-A/PROMIS-D symptom categories and two levels (≥5/≥7.5) of T-score point reductions. Changes across conditions over time for stress (Perceived Stress Scale), cancer-specific distress (Impact of Event Scale-Intrusions), and QoL (Functional Assessment of Cancer Therapy-General) were analyzed using repeated measures linear mixed-effects modeling (N = 449). Patient Global Impression of Change-Well-being was also examined.
Results: At Week 12, a greater proportion of CBSM (vs. control) participants reported normal-to-mild (vs. moderate-to-severe) PROMIS-A and PROMIS-D, and a greater proportion of CBSM participants at Week 8 or 12 had a ≥7.5 T-score reduction in PROMIS-A and a ≥5 T-score reduction in PROMIS-D (ps < .05). CBSM participants (vs. control) showed significantly greater reductions in Perceived Stress Scale and Impact of Event Scale-Intrusions and increases in Patient Global Impression of Change-Well-being and Functional Assessment of Cancer Therapy emotional and physical well-being (ps < .05), but not functional or social/family well-being.
Conclusion: Digitized CBSM benefits distress and QoL. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
期刊介绍：
The Journal of Consulting and Clinical Psychology® (JCCP) publishes original contributions on the following topics: the development, validity, and use of techniques of diagnosis and treatment of disordered behaviorstudies of a variety of populations that have clinical interest, including but not limited to medical patients, ethnic minorities, persons with serious mental illness, and community samplesstudies that have a cross-cultural or demographic focus and are of interest for treating behavior disordersstudies of personality and of its assessment and development where these have a clear bearing on problems of clinical dysfunction and treatmentstudies of gender, ethnicity, or sexual orientation that have a clear bearing on diagnosis, assessment, and treatmentstudies of psychosocial aspects of health behaviors. Studies that focus on populations that fall anywhere within the lifespan are considered. JCCP welcomes submissions on treatment and prevention in all areas of clinical and clinical–health psychology and especially on topics that appeal to a broad clinical–scientist and practitioner audience. JCCP encourages the submission of theory–based interventions, studies that investigate mechanisms of change, and studies of the effectiveness of treatments in real-world settings. JCCP recommends that authors of clinical trials pre-register their studies with an appropriate clinical trial registry (e.g., ClinicalTrials.gov, ClinicalTrialsRegister.eu) though both registered and unregistered trials will continue to be considered at this time.
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