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

Primary Purpose

Motivational Interviewing, Psychoeducation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Motivational Orientated Treatment
Psychoeducation-Oriented Treatment
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motivational Interviewing focused on measuring motivational Interviewing; motivation, psychoeducation; psychoeducational-oriented treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North York General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing (MI) Treatment

Psychoeducation-Oriented Treatment

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Eating Disorder Symptomatology
Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients

Secondary Outcome Measures

Self-ratings of motivation to recover
Measures readiness, confidence and importance of recovery
Self-ratings of Treatment Satisfaction
Measures treatment satisfaction
Completion of Program
Measures treatment program completion

Full Information

First Posted
December 14, 2017
Last Updated
April 22, 2021
Sponsor
York University
Collaborators
North York General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03643445
Brief Title
Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
Official Title
A Comparison of Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
Collaborators
North York General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motivational Interviewing, Psychoeducation
Keywords
motivational Interviewing; motivation, psychoeducation; psychoeducational-oriented treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eating disorder participants will be randomly assigned either the motivation-oriented treatment condition or the psychoeducation-oriented treatment condition. Patients in both groups will receive the same care in terms of their hospital treatment and opportunities for interaction with the staff. The only difference will be that for ½ of participants, their treatment will be infused with motivation-oriented interventions. For the others, their interactions will be infused with psychoeducation-oriented interventions. All patients have interactions with an individual therapist at various time points in their hospital treatment. The points at which a patient meets with his or her individual therapist are as follows: at the orientation to the program, a 6-week check-in, and a 10-12 week check-in. As well, patients typically meet with their individual therapist whenever the treatment team determines that a patient may be struggling in the program and is at risk of premature drop-out.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing (MI) Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation-Oriented Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Orientated Treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation-Oriented Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Disorder Symptomatology
Description
Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Self-ratings of motivation to recover
Description
Measures readiness, confidence and importance of recovery
Time Frame
8 weeks
Title
Self-ratings of Treatment Satisfaction
Description
Measures treatment satisfaction
Time Frame
up to 24 weeks
Title
Completion of Program
Description
Measures treatment program completion
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mills, Ph.D.
Organizational Affiliation
North York General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://health.yorku.ca/health-profiles/index.php?mid=162289
Description
Website of Principal Investigator

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

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