Motivational Interviewing + Cognitive Behavioural Therapy for Food Addiction

(AMI+CBTforFA Trial)

No longer recruiting at 1 trial location

Overseen By Stephanie E Cassin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ryerson University

Disqualifiers: Active suicidality, recent psychiatric hospitalizations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals who feel "addicted" to certain foods, particularly highly processed ones. Researchers are testing a combination of two therapies: adapted motivational interviewing (AMI), which emphasizes personal motivation and counseling, and cognitive behavioral therapy (CBT), known for aiding eating disorders. The goal is to determine if these therapies can reduce food cravings and improve eating habits. Individuals who feel they have a mild form of food addiction and reside in Ontario, Canada, might be suitable candidates. Sessions are conducted online, allowing convenient participation from home. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatments for food addiction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that motivational interviewing (MI) and cognitive behavioral therapy (CBT) are generally safe for people. These therapies have been used for conditions like addictions and eating disorders, involving discussions to address problems and learning new skills to manage behavior.

Studies have found that people usually tolerate these therapies well, with few reports of negative effects. Most individuals find them helpful for changing their perspectives on habits.

Since this trial combines MI and CBT for food addiction, safety evidence from other uses suggests it should also be safe for this purpose. However, discussing any concerns with the study team before joining is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) to tackle food addiction in a unique way. Unlike standard treatments that might focus solely on diet changes or medication, this approach uses personalized therapy sessions to address the psychological roots of food addiction. By integrating AMI's motivational strategies with CBT's behavior-changing techniques, this method aims to empower individuals to change their relationship with food more effectively. Plus, the convenience of videoconferencing or phone sessions makes it more accessible for participants.

What evidence suggests that this trial's treatments could be effective for food addiction?

This trial will compare an intervention combining Adapted Motivational Interviewing (AMI) and Cognitive Behavioral Therapy (CBT) with a waitlist control group. Research has shown that both motivational interviewing (MI) and cognitive behavioral therapy (CBT) can address issues related to food addiction. Studies have found that MI reduces binge eating by boosting personal motivation to change. CBT helps individuals manage their eating by altering negative thought patterns. In treatments for similar issues, MI has significantly reduced unhealthy behaviors, such as heavy drinking. Although food addiction isn't officially recognized as a disorder, using MI and CBT together appears promising because these therapies have helped with similar problems. ^{1 2 4 5 6}

Who Is on the Research Team?

Vincent A Santiago, MA

Principal Investigator

Toronto Metropolitan University

Stephanie E Cassin, PhD

Principal Investigator

Toronto Metropolitan University

Are You a Good Fit for This Trial?

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

Have access to e-mail

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a four-session adapted motivational interviewing and cognitive behavioural therapy intervention for food addiction

4 weeks

4 sessions (virtual)

Follow-up

Participants are monitored for maintenance effects of the intervention

3 months

Assessments at 1-month, 2-months, and 3-months postintervention

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: AMI and CBT Intervention Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Active Control 1 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.

Who Is Running the Clinical Trial?

Ryerson University

Lead Sponsor

Trials

77

Recruited

7,800+

Toronto Metropolitan University

Lead Sponsor

Trials

95

Recruited

19,300+

The Jackman Foundation

Collaborator

Trials

1

Recruited

90+

BMS Canada Risk Services Ltd.

Collaborator

Trials

1

Recruited

90+

Canadian Psychological Association

Collaborator

Trials

1

Recruited

90+

Council of Professional Associations of Psychology

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

In a study of 180 in-patients undergoing group psychotherapy, 60-65% reported experiencing adverse events such as mood deterioration or unwanted treatment reactions, indicating that these therapies can have significant negative effects for many individuals.

The study found that while reports of unwanted treatment reactions decreased over time, they were negatively associated with symptom improvement, and 34% of patients prematurely terminated their therapy, highlighting the need to consider patient characteristics and group conditions as predictors of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. Schneibel, R., Wilbertz, G., Scholz, C., et al.[2019]

In a study involving 164 participants, motivational interviewing (MI) was shown to be effective in reducing heavy drinking days, particularly when clients exhibited increasing levels of change talk about alcohol.

Therapist skills in MI were linked to better sexual risk outcomes, specifically reducing the likelihood of condomless sex among clients with low levels of change talk about sexual risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of therapist MI skill and client change talk class membership predicting dual alcohol and sex risk outcomes. Janssen, T., Magill, M., Mastroleo, NR., et al.[2020]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04666831

Adapted Motivational Interviewing and Cognitive ... Outcome measures will assess food addiction and binge eating symptoms, self-reported consumption of processed foods, readiness for change, eating self-efficacy, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04666831/adapted-motivational-interviewing-and-cognitive-behavioural-therapy-for-food-addiction

Adapted Motivational Interviewing and Cognitive ... H1: Compared to WLC, AMI will lead to a significantly greater reduction in food addiction symptoms (using the YFAS 2.0) at postintervention and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10283211/

Comparison of MI-oriented versus CBT-oriented adjunctive ... Our aim was to compare MI-oriented versus CBT-oriented adjunctive treatments to test whether an MI approach is superior in terms of improving therapeutic ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178112002636

The use of motivational interviewing in eating disorders This review examines the effectiveness of interventions that include the principles and techniques of motivational interviewing (MI) and its adaptations in ...

5. withpower.com withpower.com/trial/phase-bulimia-2-2021-538cd

Adapted Motivational Interviewing and Cognitive ... In a study involving 164 participants, motivational interviewing (MI) was shown to be effective in reducing heavy drinking days, particularly when clients ...

6. cochranelibrary.com cochranelibrary.com/central/doi/10.1002/central/CN-02206397/full

Adapted Motivational Interviewing and Cognitive ... ... Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction. NCT04666831. https://clinicaltrials.gov/show/NCT04666831, 2020 | added ...