Binge Eating Clinical Trial
— AMI+CBTforFAOfficial title:
Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction: A Randomized Controlled Trial
Verified date | November 2023 |
Source | Toronto Metropolitan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Food addiction is the concept that individuals can be "addicted" to foods, particularly highly processed foods. This concept has attracted growing research interest given rising obesity rates and the engineering of food products. Although food addiction is not a recognized mental disorder, individuals do identify as being addicted to foods and self-help organizations have existed since 1960 to purportedly treat it (i.e., through abstinence). However, little research has been conducted on how abstinence approaches work. Such methods may even be harmful given the risk of disordered eating. Currently, there are no empirically supported treatments for food addiction. However, evidence-based treatments do exist for addictions and eating disorders, such as motivational interviewing and cognitive behavioural therapy, which may prove beneficial for food addiction, given neural similarities between addictions and binge eating. The current study proposes a randomized controlled trial using a four-session adapted motivational interviewing (AMI) and cognitive behavioural therapy (CBT) intervention for food addiction. This intervention combines the personalized assessment feedback and person-centred counseling of AMI with CBT skills for eating disorders, such as self-monitoring of food intake. The aim is to motivate participants to enact behavioural change, such as reduced and moderate consumption of processed foods. Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, and other constructs such as emotional eating. The intervention condition will be compared to a waitlist control group. Both groups will be assessed at pre- and postintervention periods, as well as over a 3-month follow-up period to assess maintenance effects. Based on a power analysis and previous effect sizes following AMI interventions for binge eating, a total sample size of n = 58 is needed. A total of 131 individuals will be recruited to account for previous exclusion and withdrawal rates. Participation is estimated to take place from March 2021 to March 2022. All intervention sessions will be conducted virtually over secure videoconferencing technology or telephone, expanding access to all adult community members across Ontario, Canada. Twenty randomly selected session tapes will be reviewed for MI adherence.
Status | Completed |
Enrollment | 94 |
Est. completion date | January 21, 2023 |
Est. primary completion date | January 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Meets criteria on the modified Yale Food Addiction Scale 2.0 for at least "Mild Food Addiction" (2 symptoms of food addiction and clinical significance) - Fluent in English - 18 years or older - Have access to e-mail - Have access to high speed internet and Zoom OR telephone - Have private space to conduct remote therapy sessions - Must live in the province of Ontario, Canada Exclusion Criteria: - Current active suicidality or recent psychiatric hospitalizations in the past 6 months |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Metropolitan University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Toronto Metropolitan University | BMS Canada Risk Services Ltd., Canadian Psychological Association, Council of Professional Associations of Psychology, The Jackman Foundation |
Canada,
American Psychiatric Association [APA]. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596
Burmeister JM, Hinman N, Koball A, Hoffmann DA, Carels RA. Food addiction in adults seeking weight loss treatment. Implications for psychosocial health and weight loss. Appetite. 2013 Jan;60(1):103-110. doi: 10.1016/j.appet.2012.09.013. Epub 2012 Sep 24. — View Citation
Cassin SE, Buchman DZ, Leung SE, Kantarovich K, Hawa A, Carter A, Sockalingam S. Ethical, Stigma, and Policy Implications of Food Addiction: A Scoping Review. Nutrients. 2019 Mar 27;11(4):710. doi: 10.3390/nu11040710. — View Citation
Cassin SE, von Ranson KM, Heng K, Brar J, Wojtowicz AE. Adapted motivational interviewing for women with binge eating disorder: a randomized controlled trial. Psychol Addict Behav. 2008 Sep;22(3):417-25. doi: 10.1037/0893-164X.22.3.417. — View Citation
Cassin, S. E., Sijercic, I., & Montemarano, V. (2020). Psychosocial interventions for food addiction: A systematic review. Current Addiction Reports, 7, 9-19. https://doi.org/10.1007/s40429-020-00295-y
Cassin, S. E., Sockalingam, S., Wnuk, S., Strimas, R., Royal, S., Hawa, R., & Parikh, S. V. (2013). Cognitive behavioral therapy for bariatric surgery patients: Preliminary evidence for feasibility, acceptability, and effectiveness. Cognitive and Behavioral Practice, 20(4), 529-543. https://doi.org/10.1016/j.cbpra.2012.10.002
de Jong M, Schoorl M, Hoek HW. Enhanced cognitive behavioural therapy for patients with eating disorders: a systematic review. Curr Opin Psychiatry. 2018 Nov;31(6):436-444. doi: 10.1097/YCO.0000000000000452. — View Citation
Dunn EC, Neighbors C, Larimer ME. Motivational enhancement therapy and self-help treatment for binge eaters. Psychol Addict Behav. 2006 Mar;20(1):44-52. doi: 10.1037/0893-164X.20.1.44. — View Citation
Field, A. (2013). Discovering statistics using IBM SPSS statistics. Sage Publications Ltd.
Fluckiger C, Del Re AC, Wampold BE, Horvath AO. The alliance in adult psychotherapy: A meta-analytic synthesis. Psychotherapy (Chic). 2018 Dec;55(4):316-340. doi: 10.1037/pst0000172. Epub 2018 May 24. — View Citation
Gearhardt AN, Corbin WR, Brownell KD. Development of the Yale Food Addiction Scale Version 2.0. Psychol Addict Behav. 2016 Feb;30(1):113-21. doi: 10.1037/adb0000136. — View Citation
Hauck C, Weiss A, Schulte EM, Meule A, Ellrott T. Prevalence of 'Food Addiction' as Measured with the Yale Food Addiction Scale 2.0 in a Representative German Sample and Its Association with Sex, Age and Weight Categories. Obes Facts. 2017;10(1):12-24. doi: 10.1159/000456013. Epub 2017 Feb 11. — View Citation
IBM Corp. (n.d.). Impute missing data values (multiple imputation). IBM Knowledge Center. https://www.ibm.com/support/knowledgecenter/en/SSLVMB_24.0.0/spss/mva/idh_idd_mi_variables.html
Ifland JR, Preuss HG, Marcus MT, Rourke KM, Taylor WC, Burau K, Jacobs WS, Kadish W, Manso G. Refined food addiction: a classic substance use disorder. Med Hypotheses. 2009 May;72(5):518-26. doi: 10.1016/j.mehy.2008.11.035. Epub 2009 Feb 14. — View Citation
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1. — View Citation
Knowles L, Anokhina A, Serpell L. Motivational interventions in the eating disorders: what is the evidence? Int J Eat Disord. 2013 Mar;46(2):97-107. doi: 10.1002/eat.22053. Epub 2012 Sep 24. — View Citation
Koo TK, Li MY. A Guideline of Selecting and Reporting Intraclass Correlation Coefficients for Reliability Research. J Chiropr Med. 2016 Jun;15(2):155-63. doi: 10.1016/j.jcm.2016.02.012. Epub 2016 Mar 31. Erratum In: J Chiropr Med. 2017 Dec;16(4):346. — View Citation
Kramer H. Kidney Disease and the Westernization and Industrialization of Food. Am J Kidney Dis. 2017 Jul;70(1):111-121. doi: 10.1053/j.ajkd.2016.11.012. Epub 2017 Jan 23. — View Citation
Magill M, Apodaca TR, Borsari B, Gaume J, Hoadley A, Gordon REF, Tonigan JS, Moyers T. A meta-analysis of motivational interviewing process: Technical, relational, and conditional process models of change. J Consult Clin Psychol. 2018 Feb;86(2):140-157. doi: 10.1037/ccp0000250. Epub 2017 Dec 21. — View Citation
Magill M, Gaume J, Apodaca TR, Walthers J, Mastroleo NR, Borsari B, Longabaugh R. The technical hypothesis of motivational interviewing: a meta-analysis of MI's key causal model. J Consult Clin Psychol. 2014 Dec;82(6):973-83. doi: 10.1037/a0036833. Epub 2014 May 19. — View Citation
Meadows A, Nolan LJ, Higgs S. Self-perceived food addiction: Prevalence, predictors, and prognosis. Appetite. 2017 Jul 1;114:282-298. doi: 10.1016/j.appet.2017.03.051. Epub 2017 Apr 3. — View Citation
Miller, W. R., & Rollnick, S. (2013). Applications of motivational interviewing. Motivational interviewing: Helping people change (3rd ed.). Guilford Press.
Moss, M. (2013, February 20). The extraordinary science of addictive junk food. New York Times Magazine. https://www.nytimes.com/2013/02/24/magazine/the-extraordinary-science-of-junk-food.html
Moyers TB, Rowell LN, Manuel JK, Ernst D, Houck JM. The Motivational Interviewing Treatment Integrity Code (MITI 4): Rationale, Preliminary Reliability and Validity. J Subst Abuse Treat. 2016 Jun;65:36-42. doi: 10.1016/j.jsat.2016.01.001. Epub 2016 Jan 13. — View Citation
Moyers, T. B., Manuel, J. K., & Ernst, D. (2015). Motivational Interviewing Treatment Integrity Coding Manual 4.2.1. Center on Alcoholism, Substance Abuse, & Addictions [Unpublished manual]. https://casaa.unm.edu/codinginst.html
Nowell, L. S., Norris, J. M., White, D. E., & Moules, N. J. (2017). Thematic analysis: Striving to meet the trustworthiness criteria. International Journal of Qualitative Methods, 16(1), 1-13. https://doi.org/10.1177/1609406917733847
Reid, J., O'Brien, K. S., Puhl, R., Hardman, C. A., & Carter, A. (2018). Food addiction and its potential links with weight stigma. Current Addiction Reports, 5(2), 192-201. https://doi.org/10.1007/s40429-018-0205-z
Russell-Mayhew S, von Ranson KM, Masson PC. How does overeaters anonymous help its members? A qualitative analysis. Eur Eat Disord Rev. 2010 Jan;18(1):33-42. doi: 10.1002/erv.966. — View Citation
Schulte EM, Gearhardt AN. Associations of Food Addiction in a Sample Recruited to Be Nationally Representative of the United States. Eur Eat Disord Rev. 2018 Mar;26(2):112-119. doi: 10.1002/erv.2575. Epub 2017 Dec 21. — View Citation
Schulte EM, Grilo CM, Gearhardt AN. Shared and unique mechanisms underlying binge eating disorder and addictive disorders. Clin Psychol Rev. 2016 Mar;44:125-139. doi: 10.1016/j.cpr.2016.02.001. Epub 2016 Feb 4. — View Citation
Smedslund G, Berg RC, Hammerstrom KT, Steiro A, Leiknes KA, Dahl HM, Karlsen K. Motivational interviewing for substance abuse. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD008063. doi: 10.1002/14651858.CD008063.pub2. — View Citation
Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393. — View Citation
Treasure J, Leslie M, Chami R, Fernandez-Aranda F. Are trans diagnostic models of eating disorders fit for purpose? A consideration of the evidence for food addiction. Eur Eat Disord Rev. 2018 Mar;26(2):83-91. doi: 10.1002/erv.2578. Epub 2018 Jan 17. — View Citation
* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Impulsivity | Measured by the Barratt Impulsiveness Scale, 15-Item Short Form. Minimum score = 15, Maximum score = 60. Higher values mean worse outcomes. | Baseline | |
Primary | Food Addiction Symptoms | Measured by the Yale Food Addiction Scale 2.0. Minimum score = 0 symptoms, Maximum score = 11 symptoms. Greater symptoms mean worse outcome. | Change from baseline to 3 months postintervention | |
Primary | Consumption of Highly Processed Foods | Measured by the Canadian Diet History Questionnaire II. Minimum score = 0. There is no maximum score, as this measures caloric consumption. Higher values mean worse outcome. | Change from baseline to 3 months postintervention | |
Primary | Binge Eating Frequency | Measured by select Eating Disorder Examination Questionnaire 6.0 questions. Minimum score = 0. There is no maximum as this measures binge eating frequency. Higher values mean worse outcome. | Change from baseline to 3 months postintervention | |
Secondary | Motivation to Change Eating | Measured by MI Motivational Rulers. Minimum score = 0, Maximum score = 30. Higher values mean better outcome. | Change from baseline and immediately postintervention | |
Secondary | Eating Self-Efficacy (confidence to resist the desire to eat in various situations) as assessed by the Weight Efficacy Lifestyle Questionnaire | Measured by the Weight Efficacy Lifestyle Questionnaire. Minimum score = 0, Maximum score = 180. Higher values mean better outcome. | Change from baseline and immediately postintervention | |
Secondary | Weight Bias Internalization | Measured by the Modified Weight Bias Internalization Scale. Minimum score = 11, Maximum score = 77. Higher values mean worse outcome. | Change from baseline and immediately postintervention | |
Secondary | Self-Identified Food Addiction | Measured by two yes/no questions related to self-perceived food addiction. Responses are yes/no (no minimum or maximum scores). Yes means worse outcome. | Change from baseline to 3 months postintervention | |
Secondary | Addiction-like Eating Behaviour | Measured by Addiction-like Eating Behaviour Scale. Minimum score = 15, Maximum score = 75. Higher values mean worse outcome. | Change from baseline to 3 months postintervention | |
Secondary | Binge Eating Symptoms | Measured by Binge Eating Scale. Minimum score = 0, Maximum score = 46. Higher values mean worse outcome. | Change from baseline to 3 months postintervention | |
Secondary | Loss of Control Eating | Measured by Loss of Control over Eating Scale. Minimum score = 7, Maximum score = 35. Higher values mean worse outcome. | Change from baseline to 3 months postintervention | |
Secondary | Emotional Eating | Measured by Emotional Eating Scale. Minimum score = 25, Maximum score = 125. Higher values mean worse outcomes. | Change from baseline to 3 months postintervention | |
Secondary | General Appetite for Palatable Foods or Hedonic Hunger | Measured by Power of Food Scale. Minimum score = 15, Maximum score = 75. Higher values mean worse outcomes. | Change from baseline to 3 months postintervention | |
Secondary | Cravings for Specific Highly Processed Foods | Measured by Food Craving Inventory. Minimum score = 28, Maximum score = 140. Higher values mean worse outcomes. | Change from baseline to 3 months postintervention | |
Secondary | Body Mass Index | Measured by (weight/height^2). There is no minimum or maximum BMI, as it measures weight and height. For the purposes of this study, higher BMI means worse outcome although this is very individual and is not necessarily true in every case. | Change from baseline to 3 months postintervention | |
Secondary | Working Alliance | Measured by Working Alliance Short Form Revised. Minimum score = 12, Maximum score = 60. Higher values mean better outcomes. | During the intervention (change from session 1 to session 4) |
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