Motivational InterviewingNCT03643445
Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
A study testing Motivational Orientated Treatment and Psychoeducation-Oriented Treatment in people with Motivational Interviewing and Psychoeducation, run by York University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motivational Interviewing, Psychoeducation
- What is being tested?
- Motivational Orientated Treatment and Psychoeducation-Oriented Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Not Applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motivational Interviewing, Psychoeducation
- Being tested
- Motivational Orientated Treatment, Psychoeducation-Oriented Treatment
- Keywords
- motivational Interviewing; motivation, psychoeducation; psychoeducational-oriented treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Orientated TreatmentBehavioural
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation-Oriented Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Symptomatology
Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients
Measured: 8 weeks
Secondary outcomes (3)
Self-ratings of motivation to recover
Measures readiness, confidence and importance of recovery
Measured: 8 weeks
Self-ratings of Treatment Satisfaction
Measures treatment satisfaction
Measured: up to 24 weeks
Completion of Program
Measures treatment program completion
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Aug 2017
- Primary completion1 Aug 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- North York General Hospital
- Responsible party
- Principal investigator, Dr. Jennifer Mills, York University
- Investigators
- Jennifer Mills, Ph.D., Principal investigator, North York General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643445
- Sponsor's protocol ID
- 160064
- Status last verified
- Apr 2021
- First submitted
- 14 Dec 2017
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-indentified individual participant data from outcome measures will be available.
Publications
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.
PubMed 37340439
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Motivation-Oriented Versus Psychoeducation-Oriented Day Hospital Treatment for Eating Disorders
- ClinicalTrials.gov ID
- NCT03643445
- Acronym / sponsor ID
- 160064
- Conditions
- Motivational Interviewing, Psychoeducation
- Keywords
- motivational Interviewing; motivation, psychoeducation; psychoeducational-oriented treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- North York General Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) Treatment | Experimental | Behavioral: Motivational Orientated TreatmentMotivational 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. |
| Psychoeducation-Oriented Treatment | Active comparator | Behavioral: Psychoeducation-Oriented TreatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Orientated TreatmentThe 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. | Behavioural | Motivational Interviewing (MI) Treatment |
| Psychoeducation-Oriented TreatmentThe 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. | Behavioural | Psychoeducation-Oriented Treatment |
Primary outcome
Eating Disorder Symptomatology
Time frame: 8 weeks
Standard questionnaire package that determines eating disorder symptomatology in eating disorder patients
3 secondary outcomes
Self-ratings of motivation to recover
Time frame: 8 weeks
Self-ratings of Treatment Satisfaction
Time frame: up to 24 weeks
Completion of Program
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 37340439Mills 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.
- Website of Principal InvestigatorLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Non-indentified individual participant data from outcome measures will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mills, Ph.D. principal investigator
North York General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Orientated Treatment and Psychoeducation-Oriented Treatment in people with Motivational Interviewing and Psychoeducation, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Symptomatology (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.