NCT03643445

Brief Summary

  1. 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).
  2. 2.Study Hypotheses:

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

December 14, 2017

Last Update Submit

April 22, 2021

Conditions

Keywords

motivational Interviewing; motivationpsychoeducation; psychoeducational-oriented treatment

Outcome Measures

Primary Outcomes (1)

  • Eating Disorder Symptomatology

    Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients

    8 weeks

Secondary Outcomes (3)

  • Self-ratings of motivation to recover

    8 weeks

  • Self-ratings of Treatment Satisfaction

    up to 24 weeks

  • Completion of Program

    up to 24 weeks

Study Arms (2)

Motivational Interviewing (MI) Treatment

EXPERIMENTAL

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.

Behavioral: Motivational Orientated Treatment

Psychoeducation-Oriented Treatment

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation-Oriented Treatment

Interventions

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.

Motivational Interviewing (MI) 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.

Psychoeducation-Oriented Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Not Applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Related Publications (1)

  • Mills JS, Poulin LE, Kirsh G. Comparison of MI-oriented versus CBT-oriented adjunctive treatments: impacts on therapeutic alliance and patient engagement during hospital treatment for an eating disorder. J Eat Disord. 2023 Jun 20;11(1):98. doi: 10.1186/s40337-023-00818-8.

Related Links

Study Officials

  • Jennifer Mills, Ph.D.

    North York General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2017

First Posted

August 22, 2018

Study Start

August 1, 2017

Primary Completion

August 1, 2019

Study Completion

January 30, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
approximately 6-7 months, post the study completion date, will the data be available.
Access Criteria
An independent external review board will be responsible for reviewing requests for data access.

Locations