{"title":"一项平行组随机对照试验的研究方案:强化线索暴露疗法治疗消极情绪进食","authors":"Wai Sze Chan, Wing Yee Cheng","doi":"10.1016/j.cct.2025.107955","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Negative emotional eating (NEE) refers to overeating in response to negative emotions. The efficacy of cue exposure therapy (CET) for treating NEE has not been evaluated in a full-scale randomized controlled trial (RCT). Moreover, previously tested CET did not fully utilize theory-informed intervention strategies. Hence, an enhanced version of CET (<em>E</em>-CET) is here developed and evaluated. <em>E</em>-CET will integrate theory-informed intervention strategies including (1) exposures that incorporate food cues, emotional cues, and idiosyncratic contextual cues, (2) homework exposures, and, (3) explicit instructions to violate the conditioned stimulus-unconditioned stimulus (CS-US) expectancies maintaining NEE. <em>E</em>-CET is hypothesized to promote greater reductions in NEE than an active control, behavioral lifestyle intervention (BLI), and its efficacy will be mediated by the reduction in the believability of CS-US expectancies.</div></div><div><h3>Methods</h3><div>This is a parallel-group RCT. One-hundred-and-thirty-eight participants with recurring NEE will be randomly assigned to <em>E</em>-CET or BLI, and attend six individual sessions. The primary outcome is the change in the emotional eating subscale score measured by the Dutch Eating Behavior Questionnaire at posttreatment, 3-month, and 12-month follow-up from baseline. Secondary and mechanistic outcomes include changes in NEE measured by ecological momentary assessments, caloric consumption, and the believability in CS-US expectancies.</div></div><div><h3>Discussion</h3><div>If shown to be efficacious, <em>E</em>-CET can be implemented to reduce NEE. This study will be the first experimental evaluation of the mediating effects of CS-US expectancy violation in the working of <em>E</em>-CET for NEE to inform developments of the theories on CET and NEE.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107955"},"PeriodicalIF":1.9000,"publicationDate":"2025-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating\",\"authors\":\"Wai Sze Chan, Wing Yee Cheng\",\"doi\":\"10.1016/j.cct.2025.107955\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Negative emotional eating (NEE) refers to overeating in response to negative emotions. The efficacy of cue exposure therapy (CET) for treating NEE has not been evaluated in a full-scale randomized controlled trial (RCT). Moreover, previously tested CET did not fully utilize theory-informed intervention strategies. Hence, an enhanced version of CET (<em>E</em>-CET) is here developed and evaluated. <em>E</em>-CET will integrate theory-informed intervention strategies including (1) exposures that incorporate food cues, emotional cues, and idiosyncratic contextual cues, (2) homework exposures, and, (3) explicit instructions to violate the conditioned stimulus-unconditioned stimulus (CS-US) expectancies maintaining NEE. <em>E</em>-CET is hypothesized to promote greater reductions in NEE than an active control, behavioral lifestyle intervention (BLI), and its efficacy will be mediated by the reduction in the believability of CS-US expectancies.</div></div><div><h3>Methods</h3><div>This is a parallel-group RCT. One-hundred-and-thirty-eight participants with recurring NEE will be randomly assigned to <em>E</em>-CET or BLI, and attend six individual sessions. The primary outcome is the change in the emotional eating subscale score measured by the Dutch Eating Behavior Questionnaire at posttreatment, 3-month, and 12-month follow-up from baseline. Secondary and mechanistic outcomes include changes in NEE measured by ecological momentary assessments, caloric consumption, and the believability in CS-US expectancies.</div></div><div><h3>Discussion</h3><div>If shown to be efficacious, <em>E</em>-CET can be implemented to reduce NEE. This study will be the first experimental evaluation of the mediating effects of CS-US expectancy violation in the working of <em>E</em>-CET for NEE to inform developments of the theories on CET and NEE.</div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"154 \",\"pages\":\"Article 107955\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-05-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714425001491\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425001491","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Study protocol for a parallel-group, randomized controlled trial of enhanced cue exposure therapy for negative emotional eating
Background
Negative emotional eating (NEE) refers to overeating in response to negative emotions. The efficacy of cue exposure therapy (CET) for treating NEE has not been evaluated in a full-scale randomized controlled trial (RCT). Moreover, previously tested CET did not fully utilize theory-informed intervention strategies. Hence, an enhanced version of CET (E-CET) is here developed and evaluated. E-CET will integrate theory-informed intervention strategies including (1) exposures that incorporate food cues, emotional cues, and idiosyncratic contextual cues, (2) homework exposures, and, (3) explicit instructions to violate the conditioned stimulus-unconditioned stimulus (CS-US) expectancies maintaining NEE. E-CET is hypothesized to promote greater reductions in NEE than an active control, behavioral lifestyle intervention (BLI), and its efficacy will be mediated by the reduction in the believability of CS-US expectancies.
Methods
This is a parallel-group RCT. One-hundred-and-thirty-eight participants with recurring NEE will be randomly assigned to E-CET or BLI, and attend six individual sessions. The primary outcome is the change in the emotional eating subscale score measured by the Dutch Eating Behavior Questionnaire at posttreatment, 3-month, and 12-month follow-up from baseline. Secondary and mechanistic outcomes include changes in NEE measured by ecological momentary assessments, caloric consumption, and the believability in CS-US expectancies.
Discussion
If shown to be efficacious, E-CET can be implemented to reduce NEE. This study will be the first experimental evaluation of the mediating effects of CS-US expectancy violation in the working of E-CET for NEE to inform developments of the theories on CET and NEE.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.