Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders

April 22, 2021 updated by: Dr. Jennifer Mills, York University

A Comparison of Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders

  1. Study Objectives To evaluate changes in general symptomatology in patients undergoing the day hospital eating disorders program at North York General Hospital and compare symptoms between treatment groups (motivation-oriented vs. psychoeducation-oriented).

    To determine treatment satisfaction ratings in patients undergoing the day hospital program and compare satisfaction between treatment groups.

    To evaluate the acceptability of patient-centered and motivation-oriented eating disorder treatment among patients.

  2. Study Hypotheses:

Participants who receive motivation-oriented adjunctive treatment will experience larger improvements in eating disorder symptomatology 6 weeks into treatment, 10-12 weeks into treatment, and at discharge (compared to admission), and as compared to those receiving psychoeducation-oriented adjunctive treatment. Patients who receive motivation-oriented adjunctive treatment will report higher satisfaction with treatment, stronger feelings of motivation to recover, and will be more likely to complete the program as compared to those receiving psychoeducation-oriented adjunctive treatment.

Study Overview

Detailed Description

The Adult Eating Disorders Day Hospital Program at NYGH treats patients with a diagnosis of an eating disorder, including anorexia nervosa, bulimia nervosa, and other specified feeding and eating disorder. As with all intensive eating disorder treatment programs, relapse and drop-out are common occurrences. These outcomes are understood to occur when a patient is not ready to commit to the behavioural changes that are required for recovery, including normalized eating and abstinence from extreme food restriction, and bingeing and purging symptoms. Many patients struggle while they are in treatment for an eating disorder, demonstrating continued dietary restriction or urges to have symptoms like bingeing and purging.

The investigators are interested in examining whether modifications to the way in which the NYGH adult eating disorders program addresses motivation among patients will improve the quality, efficiency, and outcome of care. This study will compare two psychosocial adjunctive treatments during the standard hospital-based day treatment: one that focuses on patients' motivation to recover (motivational interviewing; MI) and the other that focuses on teaching patients about eating disorders and their associated risks (psychoeducation).

Informed by previous findings that a brief pre-treatment of MI can sometimes reduce treatment drop-out from intensive ED treatment, the current study aims to understand the effectiveness of motivation-oriented treatment for eating disorders. Based on previous research, if a patient is encouraged to reflect on and resolve obstacles to their readiness to change throughout the course of treatment, the researchers believe that objective treatment outcomes will improve alongside positive shifts in personal agency and confidence in one's ability to get better. Therefore, in addition to examining treatment completion and symptom improvement (as assessed by the standard questionnaires given to patients as part of program evaluation), the researchers will examine other psychological indicators of improvement that previous research has shown are important to consider in recovery, including treatment outcome expectancy (i.e., whether a patient feels confident that they can get better) as well as satisfaction with treatment.

The study will consist of two groups: patients will be randomly assigned to either motivation-oriented treatment or psychoeducation-oriented treatment. The researchers will include the fairly comprehensive package of outcome measures already administered to patients in this program to ensure that the researchers are looking at overall symptomatology in patients, as well as processes that could be expected to mediate outcome, such as patients' treatment outcome expectancies. The researchers will compare means on all measures between groups from pre-, mid- and end-of-treatment. The researchers believe that results from this study will add to the growing body of literature demonstrating the therapeutic benefit for motivation-oriented treatments for eating disorders and could assist the treatment team at NYGH and other hospitals with treatment planning.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Receiving treatment at NYGH in the Adult Eating Disorders Program
  2. Over 17 years old
  3. Able to speak and read English (minimum Grade 6 reading level)
  4. Able to provide informed consent

Exclusion Criteria:

1. Not Applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational Interviewing (MI) Treatment
Motivational interviewing is a psychotherapeutic stance aimed at helping patients in resolving ambivalence toward change and increasing their intrinsic motivation to engage in healthy behaviour choices. Patients assigned to these MI-trained therapists will be in the motivation-oriented condition. All individual meetings patients have with their therapist while they are in the program will entail sessions that are guided by MI principles. That is, revisiting patients' motivation to recover and overcoming obstacles to ambivalence or low motivation.
The motivation-oriented treatment condition is intended to create a context for treatment that is patient-centered, non-judgmental, and will create a therapeutic environment wherein patients can make an informed decision around their goals for treatment and their willingness to commit to the behavioural changes required for recovery from an eating disorder. In general, MI is a psychotherapeutic stance aimed at helping patients in resolving ambivalence toward change and increasing their intrinsic motivation to engage in healthy behaviour choices.
Active Comparator: Psychoeducation-Oriented Treatment
The psychoeducation-oriented treatment condition is intended to teach patients about the causes of eating disorders, the expected course of recovery, obstacles to recovery, and the importance of behavioural changes required for recovery from an eating disorder. Two staff members in the eating disorders program will deliver the psychoeducation-infused interventions, which are intended to be equivalent to treatment-as-usual in many eating disorder programs, but in a structured and standardized way, and with the use of the self-help manual. Psychoeducation is a very common intervention, often used as part of cognitive-behavioural treatment for eating disorders. The idea is that information about eating disorders and their health risks facilitates recovery and allows patients to "buy in" to treatment.
The psychoeducation-oriented treatment condition is intended to teach patients about the causes of eating disorders, the expected course of recovery, obstacles to recovery, and the importance of behavioural changes required for recovery from an eating disorder. In this condition, in order to maximize the differences between groups, no attention will be given to discussing the patient's stage of change, their level of motivation, or their own personal values around recovery. Rather, emphasis during individual meetings with their therapist will be on the importance of symptom abstinence and normal eating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Symptomatology
Time Frame: 8 weeks
Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-ratings of motivation to recover
Time Frame: 8 weeks
Measures readiness, confidence and importance of recovery
8 weeks
Self-ratings of Treatment Satisfaction
Time Frame: up to 24 weeks
Measures treatment satisfaction
up to 24 weeks
Completion of Program
Time Frame: up to 24 weeks
Measures treatment program completion
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jennifer Mills, Ph.D., North York General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Non-indentified individual participant data from outcome measures will be available.

IPD Sharing Time Frame

approximately 6-7 months, post the study completion date, will the data be available.

IPD Sharing Access Criteria

An independent external review board will be responsible for reviewing requests for data access.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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