Bulimia Nervosa Clinical Trial
— EASEDOfficial title:
Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans With Eating Disorders (EASED Study)
When untreated, eating disorders present with tremendous burdens to affected active duty Service members and Veterans and their families, and are very costly to the DoD and VA healthcare system. A comparative effectiveness study with state-of-the-art virtual treatment for BN and BED specifically adapted for testing with the Veteran population and other underrepresented eating disorder populations will lead to major improvements in clinical outcomes. The treatment will be integrated with VA's newest telehealth technology to profoundly enhance access to care anywhere, at any time. This trial of therapist-led and self-help CBT treatments, combined with our expert panel methods to inform VA Clinical Practice Guidelines for Eating Disorders and plans for dissemination, will accelerate the pace for the transition of results both for large-scale deployment in the VA system and for real-world impact among diverse and underrepresented eating disorder populations.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | September 29, 2025 |
Est. primary completion date | September 29, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 18 and older - Presence of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Bulimia Nervosa (BN) or Binge Eating Disorder (BED) - Veteran Health Administration (VHA) user Exclusion Criteria: - Active psychosis or high acute risk for suicide - Medical or psychiatric illness, or cognitive deficits, that interfere with providing consent, completing assessments, or engaging in treatment for eating disorders - Pregnancy or lactation - Patients with suspected Anorexia or Atypical Anorexia will be excluded and referred to other VA care services |
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Connecticut Healthcare System | United States Department of Defense |
United States,
Agras WS, Fitzsimmons-Craft EE, Wilfley DE. Evolution of cognitive-behavioral therapy for eating disorders. Behav Res Ther. 2017 Jan;88:26-36. doi: 10.1016/j.brat.2016.09.004. — View Citation
Allison KC, Lundgren JD, O'Reardon JP, Martino NS, Sarwer DB, Wadden TA, Crosby RD, Engel SG, Stunkard AJ. The Night Eating Questionnaire (NEQ): psychometric properties of a measure of severity of the Night Eating Syndrome. Eat Behav. 2008 Jan;9(1):62-72. doi: 10.1016/j.eatbeh.2007.03.007. Epub 2007 Mar 28. — View Citation
American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing; 2013.
Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74. — View Citation
Bartlett BA, Mitchell KS. Eating disorders in military and veteran men and women: A systematic review. Int J Eat Disord. 2015 Dec;48(8):1057-69. doi: 10.1002/eat.22454. Epub 2015 Aug 27. — View Citation
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. — View Citation
Bellows BK, DuVall SL, Kamauu AW, Supina D, Babcock T, LaFleur J. Healthcare costs and resource utilization of patients with binge-eating disorder and eating disorder not otherwise specified in the Department of Veterans Affairs. Int J Eat Disord. 2015 Dec;48(8):1082-91. doi: 10.1002/eat.22427. Epub 2015 May 8. — View Citation
Bellows BK, LaFleur J, Kamauu AW, Ginter T, Forbush TB, Agbor S, Supina D, Hodgkins P, DuVall SL. Automated identification of patients with a diagnosis of binge eating disorder from narrative electronic health records. J Am Med Inform Assoc. 2014 Feb;21(e1):e163-8. doi: 10.1136/amiajnl-2013-001859. Epub 2013 Nov 7. — View Citation
Daeppen JB, Yersin B, Landry U, Pecoud A, Decrey H. Reliability and validity of the Alcohol Use Disorders Identification Test (AUDIT) imbedded within a general health risk screening questionnaire: results of a survey in 332 primary care patients. Alcohol Clin Exp Res. 2000 May;24(5):659-65. — View Citation
Economic Research Service, USDA. U.S. Household Food Security Survey Module: Six-Item Short Form. 2012.
Fairburn C, Cooper Z, O'Connor M. Eating disorder examination: Edition 17.0D. 2014.
Fairburn C. Overcoming binge eating. Guilford Press; 1995.
Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. — View Citation
Fairburn, C. G. & cooper, Z. The eating disorder examination. in Fairburn, C. G., Wilson, G. T., & Schleimer, K. (1993). Binge eating: Nature, assessment, and treatment (pp. 317-360). New York: Guilford Press.
Foa EB, Riggs DS, Dancu CV, Rothbaum BO. Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. J Traum Stress. 1993;6(4):459-473. https://doi.org/10.1002/jts.2490060405. doi: https://doi.org/10.1002/jts.2490060405.
Forbush KT, Wildes JE, Pollack LO, Dunbar D, Luo J, Patterson K, Petruzzi L, Pollpeter M, Miller H, Stone A, Bright A, Watson D. Development and validation of the Eating Pathology Symptoms Inventory (EPSI). Psychol Assess. 2013 Sep;25(3):859-78. doi: 10.1037/a0032639. Epub 2013 Jul 1. — View Citation
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation
Godin G. The godin-shephard leisure-time physical activity questionnaire. Health Fit J Can. 2011;4(1):18-22. https://hfjc.library.ubc.ca/index.php/HFJC/article/view/82. doi: 10.14288/hfjc.v4i1.82.
Gratz, K. L. & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.
Grilo CM, Masheb RM, Brody M, Burke-Martindale CH, Rothschild BS. Binge eating and self-esteem predict body image dissatisfaction among obese men and women seeking bariatric surgery. Int J Eat Disord. 2005 May;37(4):347-51. doi: 10.1002/eat.20130. — View Citation
Grilo CM, Masheb RM, Salant SL. Cognitive behavioral therapy guided self-help and orlistat for the treatment of binge eating disorder: a randomized, double-blind, placebo-controlled trial. Biol Psychiatry. 2005 May 15;57(10):1193-201. doi: 10.1016/j.biopsych.2005.03.001. — View Citation
Grilo CM, Masheb RM, Wilson GT, Gueorguieva R, White MA. Cognitive-behavioral therapy, behavioral weight loss, and sequential treatment for obese patients with binge-eating disorder: a randomized controlled trial. J Consult Clin Psychol. 2011 Oct;79(5):675-85. doi: 10.1037/a0025049. — View Citation
Grilo CM, Masheb RM, Wilson GT. A comparison of different methods for assessing the features of eating disorders in patients with binge eating disorder. J Consult Clin Psychol. 2001 Apr;69(2):317-22. doi: 10.1037//0022-006x.69.2.317. — View Citation
Grilo CM, Masheb RM, Wilson GT. Different methods for assessing the features of eating disorders in patients with binge eating disorder: a replication. Obes Res. 2001 Jul;9(7):418-22. doi: 10.1038/oby.2001.55. — View Citation
Grilo CM, Masheb RM, Wilson GT. Efficacy of cognitive behavioral therapy and fluoxetine for the treatment of binge eating disorder: a randomized double-blind placebo-controlled comparison. Biol Psychiatry. 2005 Feb 1;57(3):301-9. doi: 10.1016/j.biopsych.2004.11.002. — View Citation
Gueorguieva R, Krystal JH. Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry. 2004 Mar;61(3):310-7. doi: 10.1001/archpsyc.61.3.310. — View Citation
Guerdjikova AI, McElroy SL, Winstanley EL, Nelson EB, Mori N, McCoy J, Keck PE Jr, Hudson JI. Duloxetine in the treatment of binge eating disorder with depressive disorders: a placebo-controlled trial. Int J Eat Disord. 2012 Mar;45(2):281-9. doi: 10.1002/eat.20946. Epub 2011 Jul 8. — View Citation
Gusi, N., Olivares, P. R., & Rajendram, R. (2010). The EQ-5D health-related quality of life questionnaire. Handbook of Disease Burdens and Quality of Life Measures, 87-99.
Gusi, N., P. Olivares, and R. Rajendram, The EQ-5D Health-Related Quality of Life Questionnaire, in Handbook of Disease Burdens and Quality of Life Measures R.R.W. Victor R. Preedy, Editor. 2010, Springer New York: New York. p. 87-99.
Hedeker D, Mermelstein RJ, Demirtas H. Analysis of binary outcomes with missing data: missing = smoking, last observation carried forward, and a little multiple imputation. Addiction. 2007 Oct;102(10):1564-73. doi: 10.1111/j.1360-0443.2007.01946.x. — View Citation
Higgins DM, Dorflinger L, MacGregor KL, Heapy AA, Goulet JL, Ruser C. Binge eating behavior among a national sample of overweight and obese veterans. Obesity (Silver Spring). 2013 May;21(5):900-3. doi: 10.1002/oby.20160. Erratum In: Obesity (Silver Spring). 2014 Aug;22(8):1935-6. — View Citation
Hilbert A, Bishop ME, Stein RI, Tanofsky-Kraff M, Swenson AK, Welch RR, Wilfley DE. Long-term efficacy of psychological treatments for binge eating disorder. Br J Psychiatry. 2012 Mar;200(3):232-7. doi: 10.1192/bjp.bp.110.089664. Epub 2012 Jan 26. — View Citation
Hilbert A, Petroff D, Herpertz S, Pietrowsky R, Tuschen-Caffier B, Vocks S, Schmidt R. Meta-analysis of the efficacy of psychological and medical treatments for binge-eating disorder. J Consult Clin Psychol. 2019 Jan;87(1):91-105. doi: 10.1037/ccp0000358. — View Citation
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems and barriers to care. US Army Med Dep J. 2008 Jul-Sep:7-17. — View Citation
Hudson JI, Hiripi E, Pope HG Jr, Kessler RC. The prevalence and correlates of eating disorders in the National Comorbidity Survey Replication. Biol Psychiatry. 2007 Feb 1;61(3):348-58. doi: 10.1016/j.biopsych.2006.03.040. Epub 2006 Jul 3. Erratum In: Biol Psychiatry. 2012 Jul 15;72(2):164. — View Citation
Joint Commission on Hospital Accreditation. APPROVED: New Requirements for Residential and Outpatient Eating Disorders Programs. Effective July 1, 2016, for Behavioral Health Care Accreditation Program. Jt Comm Perspect. 2016 Jan;36(1):4-9. No abstract available. — View Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation
Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals. 2002;32(9):509-515. doi: 10.3928/0048-5713-20020901-06.
Latner JD, Mond JM, Kelly MC, Haynes SN, Hay PJ. The Loss of Control Over Eating Scale: development and psychometric evaluation. Int J Eat Disord. 2014 Sep;47(6):647-59. doi: 10.1002/eat.22296. Epub 2014 May 26. — View Citation
Linardon J, Fairburn CG, Fitzsimmons-Craft EE, Wilfley DE, Brennan L. The empirical status of the third-wave behaviour therapies for the treatment of eating disorders: A systematic review. Clin Psychol Rev. 2017 Dec;58:125-140. doi: 10.1016/j.cpr.2017.10.005. Epub 2017 Oct 23. — View Citation
Linardon J, Wade TD, de la Piedad Garcia X, Brennan L. The efficacy of cognitive-behavioral therapy for eating disorders: A systematic review and meta-analysis. J Consult Clin Psychol. 2017 Nov;85(11):1080-1094. doi: 10.1037/ccp0000245. — View Citation
Linardon J, Wade TD. How many individuals achieve symptom abstinence following psychological treatments for bulimia nervosa? A meta-analytic review. Int J Eat Disord. 2018 Apr;51(4):287-294. doi: 10.1002/eat.22838. Epub 2018 Feb 8. — View Citation
Masheb RM, Chan SH, Raffa SD, Ackermann R, Damschroder LJ, Estabrooks PA, Evans-Hudnall G, Evans NC, Histon T, Littman AJ, Moin T, Nelson KM, Pagoto S, Pronk NP, Tate DF, Goldstein MG. State of the art conference on weight management in VA: Policy and research recommendations for advancing behavioral interventions. J Gen Intern Med. 2017 Apr;32(Suppl 1):74-78. doi: 10.1007/s11606-016-3965-y. — View Citation
Masheb RM, Grilo CM, Rolls BJ. A randomized controlled trial for obesity and binge eating disorder: low-energy-density dietary counseling and cognitive-behavioral therapy. Behav Res Ther. 2011 Dec;49(12):821-9. doi: 10.1016/j.brat.2011.09.006. Epub 2011 Sep 28. — View Citation
Masheb RM, Lutes LD, Kim HM, Holleman RG, Goodrich DE, Janney CA, Kirsh S, Richardson CR, Damschroder LJ. High-frequency binge eating predicts weight gain among veterans receiving behavioral weight loss treatments. Obesity (Silver Spring). 2015 Jan;23(1):54-61. doi: 10.1002/oby.20931. Epub 2014 Nov 11. — View Citation
Moss TP, Rosser BA. The moderated relationship of appearance valence on appearance self consciousness: development and testing of new measures of appearance schema components. PLoS One. 2012;7(11):e50605. doi: 10.1371/journal.pone.0050605. Epub 2012 Nov 30. — View Citation
Phimphasone-Brady P, Dorflinger LM, Ruser C, Bullock A, Godfrey KM, Hernandez D, Min KM, Masheb RM. Self-report versus objective measurement of weight history: implications for pre-treatment weight gain. J Behav Med. 2019 Dec;42(6):1142-1147. doi: 10.1007/s10865-019-00045-0. Epub 2019 Apr 23. — View Citation
Rosenberg, M. (1979). Conceiving the Self. New York: Basic Books.
Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x. — View Citation
Sayer NA, Friedemann-Sanchez G, Spoont M, Murdoch M, Parker LE, Chiros C, Rosenheck R. A qualitative study of determinants of PTSD treatment initiation in veterans. Psychiatry. 2009 Fall;72(3):238-55. doi: 10.1521/psyc.2009.72.3.238. — View Citation
Selim AJ, Rogers W, Fleishman JA, Qian SX, Fincke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-item Health Survey (VR-12). Qual Life Res. 2009 Feb;18(1):43-52. doi: 10.1007/s11136-008-9418-2. Epub 2008 Dec 3. — View Citation
Spielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). Manual for the State-Trait Anxiety Inventory. Polo Alto, CA: Consulting Psychologists Press.
Spitzer RL, Yanovski S, Wadden T, Wing R, Marcus MD, Stunkard A, Devlin M, Mitchell J, Hasin D, Horne RL. Binge eating disorder: its further validation in a multisite study. Int J Eat Disord. 1993 Mar;13(2):137-53. — View Citation
Sysko R, Walsh BT, Fairburn CG. Eating Disorder Examination-Questionnaire as a measure of change in patients with bulimia nervosa. Int J Eat Disord. 2005 Mar;37(2):100-6. doi: 10.1002/eat.20078. — View Citation
Udo T, Bitley S, Grilo CM. Suicide attempts in US adults with lifetime DSM-5 eating disorders. BMC Med. 2019 Jun 25;17(1):120. doi: 10.1186/s12916-019-1352-3. — View Citation
Wilfley DE, Welch RR, Stein RI, Spurrell EB, Cohen LR, Saelens BE, Dounchis JZ, Frank MA, Wiseman CV, Matt GE. A randomized comparison of group cognitive-behavioral therapy and group interpersonal psychotherapy for the treatment of overweight individuals with binge-eating disorder. Arch Gen Psychiatry. 2002 Aug;59(8):713-21. doi: 10.1001/archpsyc.59.8.713. — View Citation
Wilson GT, Wilfley DE, Agras WS, Bryson SW. Psychological treatments of binge eating disorder. Arch Gen Psychiatry. 2010 Jan;67(1):94-101. doi: 10.1001/archgenpsychiatry.2009.170. — View Citation
* Note: There are 57 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE). | The EDE is the structured diagnostic interview that is considered the gold-standard to diagnose, and assess the symptoms of, eating disorders including binge eating, purging behaviors, and eating disorder pathology. | baseline, 3 months (post-treatment), and 6 months | |
Primary | Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q) | The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials61and has adequate convergence with the interview format62,63. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. | baseline, 3 months (post-treatment), and 6 months | |
Secondary | A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9). | The PHQ-9 a 9-item self-report questionnaire used to assess for the presence and severity of the symptoms of depression. | baseline, 3 months (post-treatment), and 6 months | |
Secondary | A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A. | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Criterion A will be assessed using a standard brief assessment. | baseline, 3 months (post-treatment), and 6 months | |
Secondary | Self-assessment of overall wellness as assessed by the Yale Eating and Weight Quality of Life Scale (Yale QoL) and the Visual Analog Scale (VAS) within the European Quality of Life Screener (Euro QoL). | Yale QoL evaluates eight aspects of overall quality of life based specifically on the impact of weight or eating on each domain (physical activity, self-care, daily responsibilities, relationships, public distress, physical discomfort, emotional distress, and shame or guilt). The VAS is used to assess perceived health status ranging from 0 to 100. | baseline, 3 months (post-treatment), and 6 months | |
Secondary | Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys. | The Skills Confidence survey is a 12-item measure used to determine a participant's level of confidence in a number of skills taught during treatment. Participants can answer on a scale ranging from strongly disagree to strongly agree. The Materials Engagement survey is an 11-item measure used to determine a participant's level of engagement in the materials. The Treatment Satisfaction survey is an 11-item measure that is used to determine how helpful a number of skills were to manage a participant's binge eating behaviors on a scale from 0 to 4. | 3 months (post-treatment) |
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