Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction

NCT04666831 | Completed

• 1 other identifier: REB 2020-517
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Addiction; Binge Eating

Keywords

food addiction; motivational interviewing; cognitive behavioural therapy; eating disorders; binge eating

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (12)

• Motivation to Change Eating

  Change from baseline and immediately postintervention

• Eating Self-Efficacy (confidence to resist the desire to eat in various situations) as assessed by the Weight Efficacy Lifestyle Questionnaire

  Change from baseline and immediately postintervention

• Weight Bias Internalization

  Change from baseline and immediately postintervention

• Self-Identified Food Addiction

  Change from baseline to 3 months postintervention

• Addiction-like Eating Behaviour

  Change from baseline to 3 months postintervention

Other Outcomes (1)

• Impulsivity

  Baseline

Study Arms (2)

AMI and CBT Intervention

EXPERIMENTAL

Participants will receive four weekly sessions of individual therapy (60 minutes) with a graduate student therapist over videoconferencing technology or telephone. The intervention combines Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) techniques for food addiction. Participants will complete questionnaires at baseline, postintervention or 1-month postbaseline, and 2- and 4-months postbaseline.

Behavioral: Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)

Waitlist Control

NO INTERVENTION

Participants will complete questionnaires at baseline, 1-month postbaseline, and 2- and 4-months postbaseline (at timepoints comparable to the intervention arm). They will not receive any intervention during this time. Following the 3-month waitlist, they will cross over into the same procedure as the intervention arm.

Interventions

Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) BEHAVIORAL

The intervention combines AMI techniques as described by Miller and Rollnick (2013) in the third edition of their Motivational Interviewing book, as well as CBT techniques from the Tele-CBT protocol for bariatric surgery patients by Cassin et al. (2013).

AMI and CBT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \- Current active suicidality or recent psychiatric hospitalizations in the past 6 months

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• The Jackman Foundation: collaborator
• BMS Canada Risk Services Ltd.: collaborator
• Canadian Psychological Association: collaborator
• Council of Professional Associations of Psychology: collaborator

Study Sites (1)

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

Location

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MeSH Terms

Conditions

Food Addiction; Bulimia; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie E Cassin, PhD

  Toronto Metropolitan University

  STUDY DIRECTOR

• Vincent A Santiago, MA

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since this study uses a behavioural intervention (psychotherapy), neither the participant nor the care provider can be blinded. Outcomes are assessed using online questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to an intervention condition (AMI + CBT) or a waitlist control (WLC) group. The WLC group will crossover into the AMI + CBT group following a 3-month waitlist.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 14, 2020
• Study Start: March 7, 2021
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)