- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643445
Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
A Comparison of Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
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.
- 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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M2K 1E1
- North York General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receiving treatment at NYGH in the Adult Eating Disorders Program
- Over 17 years old
- Able to speak and read English (minimum Grade 6 reading level)
- Able to provide informed consent
Exclusion Criteria:
1. Not Applicable
Study Plan
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.
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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
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Mills, Ph.D., North York General Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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