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PreprintCited by 0Eating Disorders and BehaviorsDigital Mental Health InterventionsNutrition, Health and Food Behavior

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Combining Digital Cognitive Behavioral Therapy With Mindfulness Training for Binge Eating Disorder: Protocol for a Feasibility Trial (Preprint)

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Sala, Margaret, Roos, Corey, Ascarrunz, Dante, Stern, Casey M, Bricker, Jonathan, Feldman, Jonathan M, Levinson, Cheri, Aslan, Mihaela, Hay, Jennifer L, Kober, Hedy·2026·JMIR Research Protocols
DOI 10.2196/preprints.91761PMC PMC13135158

Preprint — published as 10.2196/91761 · Paper page

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Abstract

BACKGROUND: Cognitive behavioral therapy (CBT) is the most effective treatment for binge eating disorder (BED) but is limited by modest efficacy and low reach of in-person delivery. Combining mindfulness training with CBT could enhance efficacy by targeting emotion dysregulation, a key factor in BED that CBT does not adequately target. Digital delivery can enhance the reach of treatment. Accordingly, we developed CBT-based Mindful Courage, a 16-session digital intervention combining CBT and mindfulness training for BED. OBJECTIVE: The aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility (intervention and assessment completion) and acceptability (usability, overall satisfaction, engagement, visual appeal of content, understandability of program content, desire to continue the program, perceived skill acquisition, perceived confidence in implementing skills, and perceived helpfulness) of CBT-based Mindful Courage. We will also evaluate changes in outcomes (binge eating frequency, eating disorder symptoms, clinical impairment, and depression symptoms) and mechanisms (emotion dysregulation, dietary overrestriction, and trait mindfulness). METHODS: This is a parallel-group, single-blinded, randomized controlled trial with a 1:1 allocation ratio. It will be conducted from November 2025 to November 2026, with study assessments at baseline, midtreatment, end-of-treatment, and 2-month follow-up. We will recruit a volunteer sample of adults with BED (N=40) aged 18 to 75 years via online advertisements. Exclusion criteria include a BMI <18.5, current anorexia or bulimia nervosa, and current treatment for BED or weight loss. Participants will be randomly allocated to an active control that includes coached self-monitoring (self-monitoring of food intake in Recovery Record and coaching calls by a research assistant) or to CBT-based Mindful Courage+coached self-monitoring. Both conditions will have a duration of 18 weeks. All study sessions will take place over Zoom. RESULTS: The study was funded in April 2023. Data collection began in November 2025, and we anticipate recruitment to be completed by November 2026. Results are expected to be analyzed by May 2027 and published by May 2028. CONCLUSIONS: This will be an important first step in creating a scalable and efficacious treatment for BED. CLINICALTRIAL: ClinicalTrials.gov NCT07212673; https://clinicaltrials.gov/study/NCT07212673 INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/91761

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References 67

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  1. 10.1016/s2215-0366(21)00040-7 · DOI · Paper page
  2. 10.1016/j.psc.2017.01.003 · DOI
  3. 10.1016/j.biopsych.2006.03.040 · DOI · Paper page
  4. 10.1002/eat.22452 · DOI
  5. 10.1037/a0024455 · DOI
  6. 10.1186/s12888-024-05943-5 · DOI
  7. 10.1007/s40519-014-0173-9 · DOI · Paper page
  8. 10.1016/s0005-7967(02)00088-8 · DOI · Paper page
  9. 10.1016/j.brat.2015.04.010 · DOI
  10. 10.1037/a0023660 · DOI · Paper page
  11. 10.1016/j.cpr.2017.12.004 · DOI
  12. 10.1016/j.neubiorev.2014.12.008 · DOI
  13. 10.1017/s0033291713001098 · DOI · Paper page
  14. 10.1017/S0033291716003317 · DOI · Paper page
  15. 10.1177/1745691611419671 · DOI · Paper page
  16. 10.1007/s10865-014-9610-5 · DOI · Paper page
  17. 10.1007/s12671-019-01216-5 · DOI
  18. 10.1002/erv.2673 · DOI · Paper page
  19. 10.1016/j.beth.2023.01.003 · DOI · Paper page
  20. 10.1002/eat.23564 · DOI
  21. 10.1016/j.cpr.2011.03.004 · DOI · Paper page
  22. 10.1080/10640266.2019.1591827 · DOI
  23. 10.1017/s0033291721001999 · DOI · Paper page
  24. 10.1016/j.sleep.2020.08.020 · DOI · Paper page
  25. 10.1016/j.cpr.2016.03.009 · DOI · Paper page
  26. 10.1177/1357633x17717402 · DOI · Paper page
  27. 10.1037/ccp0000575 · DOI · Paper page
  28. 10.1002/erv.3204 · DOI
  29. 10.1002/fgc.33961 · DOI
  30. 10.1177/2167702613497932 · DOI · Paper page
  31. 10.1016/j.conctc.2024.101338 · DOI
  32. 10.2196/jmir.4790 · DOI · Paper page
  33. 10.1146/annurev-clinpsy-021815-093006 · DOI · Paper page
  34. 10.1007/s12160-009-9130-7 · DOI · Paper page
  35. 10.1016/j.cbpra.2015.12.005 · DOI · Paper page
  36. 10.1016/b978-0-12-416031-6.00007-4 · DOI
  37. 10.1002/eat.23512 · DOI · Paper page
  38. 10.1007/s12671-012-0179-1 · DOI · Paper page
  39. 10.1002/shi.90 · DOI
  40. 10.1002/eat.22386 · DOI · Paper page
  41. 10.1002/erv.3053 · DOI
  42. 10.1002/eat.23652 · DOI
  43. 10.1001/jamanetworkopen.2020.15633 · DOI · Paper page
  44. 10.1002/eat.22477 · DOI · Paper page
  45. 10.1016/j.brat.2009.05.006 · DOI · Paper page
  46. 10.1201/9781498710411-35 · DOI · Paper page
  47. 10.1007/s10209-014-0348-1 · DOI · Paper page
  48. 10.1037/t03974-000 · DOI · Paper page
  49. 10.1016/j.brat.2008.06.012 · DOI · Paper page
  50. 10.1046/j.1525-1497.2001.016009606.x · DOI · Paper page
  51. 10.1002/eat.20931 · DOI · Paper page
  52. 10.1016/j.psychres.2003.03.001 · DOI
  53. 10.1016/j.psychres.2006.08.002 · DOI
  54. 10.1177/1049732320924625 · DOI
  55. 10.1002/eat.20665 · DOI
  56. 10.1002/eat.20653 · DOI
  57. 10.1007/s10862-015-9529-3 · DOI · Paper page
  58. 10.1007/s10862-006-9035-8 · DOI · Paper page
  59. 10.1007/s10862-019-09736-z · DOI
  60. 10.1037/0022-3514.54.6.1063 · DOI · Paper page
  61. 10.1080/0963823031000103489 · DOI · Paper page
  62. 10.1016/s0005-7894(00)80009-x · DOI · Paper page
  63. 10.1001/archinte.166.10.1092 · DOI · Paper page
  64. 10.1002/1098-108x(198707)6:4<485::aid-eat2260060405>3.0.co;2-o · DOI
  65. 10.1016/0306-4603(82)90024-7 · DOI · Paper page
  66. 10.1037/1040-3590.12.2.123 · DOI

Metadata

Authors
Sala, M., Roos, C., Ascarrunz, D., Stern, C. M., Bricker, J., Feldman, J. M., Levinson, C., Aslan, M., Hay, J. L., & Kober, H.
Affiliations
  • Yeshiva University (US)
  • Yale University (US)
  • Albert Einstein College of Medicine (US)
  • University of Washington (US)
  • University of Louisville (US)
  • Memorial Sloan Kettering Cancer Center (US)
Corresponding author
Sala, Margaret
ORCID
Venue
JMIR Research Protocols
Publisher
JMIR Publications Inc.
Published
2026-01-19
Volume
15
Pages
e91761-e91761
ISSN
1929-0748 (ISSN-L)
DOI
10.2196/preprints.91761
PMC
PMC13135158
OpenAlex
W7134927003
Cited by
0
References
67
FWCI
0.00
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JMIR Research Protocols (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • National Institutes of Health
  • National Center for Complementary and Integrative Health (K23AT012126)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Eating Disorders and Behaviors
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Health Sciences › Nursing › Nutrition and Dietetics › Nutrition, Health and Food Behavior
Keywords
binge eating disorder, digital cognitive behavioral therapy, mindfulness training, emotional dysregulation, trait mindfulness, self-monitoring, treatment acceptability, feasibility, depressive symptoms, eating disorder symptoms, telehealth intervention, eating disorder prevention
MeSH terms
Adolescent, Adult, Feasibility Studies, Female, Humans, Male, Middle Aged, Pilot Projects, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Young Adult, Binge-Eating Disorder, Mindfulness

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