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.