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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03643445
Other study ID # 160064
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date January 30, 2020

Study information

Verified date April 2021
Source York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 30, 2020
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Motivational Orientated Treatment
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.
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. 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.

Locations

Country Name City State
Canada North York General Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
York University North York General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Disorder Symptomatology Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients 8 weeks
Secondary Self-ratings of motivation to recover Measures readiness, confidence and importance of recovery 8 weeks
Secondary Self-ratings of Treatment Satisfaction Measures treatment satisfaction up to 24 weeks
Secondary Completion of Program Measures treatment program completion up to 24 weeks
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