Adapted Motivational Interviewing and Cognitive Behavioural Therapy for Food Addiction

(AMI+CBTforFA Trial)

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

94 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment combining motivational counseling and practical skills training for adults who feel addicted to processed foods. Motivational Interviewing (MI) is a collaborative therapy that focuses on strengthening a person's internal motivation to change. The goal is to help participants understand their motivations for change and learn how to manage their eating habits better. The study will compare this treatment to see if it reduces food addiction and binge eating.

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.

What data supports the effectiveness of the treatment Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)?

Research shows that combining motivational interviewing (a counseling approach to encourage behavior change) and cognitive-behavioral therapy (a type of talk therapy) is effective in treating alcohol use disorders and depression, suggesting it may help with other conditions too. ^{1 2 3 4 5}

Is Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) generally safe for humans?

Research shows that serious adverse events (SAEs) in psychosocial treatments like AMI and CBT are rare and often not related to the therapy itself. When CBT is practiced correctly, the rate of adverse events is low, similar to or lower than using a placebo. ^{6 7 8 9 10}

How does the treatment Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT) differ from other treatments?

This treatment combines Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT), which is unique because it focuses on enhancing motivation and engagement in therapy, potentially leading to better outcomes compared to standard treatments that may not address motivation as directly. ^{2 4 11 12 13}

Research Team

Vincent A Santiago, MA

Principal Investigator

Toronto Metropolitan University

Stephanie E Cassin, PhD

Principal Investigator

Toronto Metropolitan University

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of telephone motivational interviewing to enhance mental health treatment engagement in Iraq and Afghanistan veterans. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of Motivational Interviewing to reduce alcohol and drug use among patients with depression. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of comorbid alcohol use disorders and depression with cognitive-behavioural therapy and motivational interviewing: a meta-analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Brief cognitive behavioural interventions for regular amphetamine users: a step in the right direction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The role of therapist MI skill and client change talk class membership predicting dual alcohol and sex risk outcomes. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse events of group psychotherapy in the in-patient setting - results of a naturalistic trial. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

How to Measure Motivational Interviewing Fidelity in Randomized Controlled Trials: Practical Recommendations. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Motivational interviewing to enhance psychosocial treatment attendance in people with SMI. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Motivational Interviewing as an Adjunct to Cognitive Behavioral Therapy for Anxiety. [2019]