- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07319936
The Acceptability and Effectiveness of Receiving a Low-intensity Self-guided Psychoeducational Intervention for Individuals Waitlisted for Specialized Eating-disorder Treatment
The Acceptability and Effectiveness of a Virtual Psychoeducational Intervention for Individuals Waitlisted for Specialized Eating Disorder Treatment
It is often difficult for people with eating disorders to get timely access to specialized treatment, as waitlists can be long. The present study examines whether or not providing educational materials by email could help individuals with eating disorders while they wait for specialized care. The investigators hypothesize that a low-intensity self-guided intervention will lead to a reduction in eating-disorder attitudes and cognitions, and an increase in motivation to change and body satisfaction.
Sixty-two adults (primarily women) are randomly assigned to one of two groups while being on the waitlist for specialized eating-disorder services. One group receives weekly emails for four weeks with psychoeducational materials about eating disorders; the other group does not receive any materials. The content was adapted from a validated eating-disorder workbook developed by the Centre for Clinical Interventions in Australia and translated into French. Each week, as well as one week after the intervention period, all participants complete brief questionnaires assessing eating-disorder thoughts, body satisfaction, and readiness to make changes in eating behaviours. Participants who receive the materials also rate their level of satisfaction with the materials as well as how useful and engaging they find the content.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4H 1R3
- Douglas Mental Health University Instititute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Between 18-65 years and have a diagnosis of Anorexia Nervosa, Bulimia Nervosa or Other Specified Feeding or Eating Disorders (OSFED) as defined by DSM-5 criteria.
Exclusion Criteria:
- Current substance use disorder
- Comorbid psychotic disorder
- Major physical symptoms that could interfere with the intervention or or requiring urgent care (referred to priority 1 during phone evals)
- Body mass index lower than 15
- Pregnancy
- Insufficient access to the internet (by phone, tablet or computer) to complete the intervention
- Not being able to access 2-3 modules for 4 consecutive weeks.
Information on presence of current substance use disorder, comorbid psychotic disorder, major physical symptoms, body mass index and pregnancy are based on information from the clinical referal form and information from the initial screening for treatment eligibility in the eating-disorder program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental condition
Participants in the experimental group receive weekly psychoeducational materials related to eating disorders via email, for 4 weeks, while on the waitlist for treatment.
|
Receives weekly psychoeducation related to eating disorders via email, while on the waitlist for treatment [experimental condition].
|
|
Other: No psycho-education
Participants in the control group do not receive any psychoeducational materials, while on the waitlist for treatment.
|
Does not receive any psychoeducational materials, while on the waitlist for treatment [control condition].
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder-15
Time Frame: Weekly, from enrollment to the end of the study at week 5 (week 0, 1, 2, 3, 4, 5)
|
10 items that assess eating-disorder symptoms, each rated on a 7-point Likert frequency scale, ranging from 0 (not at all) to 7 (all the time).
A higher score means more symptoms.
|
Weekly, from enrollment to the end of the study at week 5 (week 0, 1, 2, 3, 4, 5)
|
|
Body Satisfaction Scale
Time Frame: Weekly, from enrollment until the last time the materials were offered (week 0, 1, 2, 3, 4).
|
State-related changes in body satisfaction are assessed using the Body Dissatisfaction subscale of the Body Satisfaction Scale (BSS).
The subscale asks participants to indicate their level of satisfaction with seven body parts (e.g., chest, tummy, legs, etc.) at the time of questionnaire completion on a 7-point Likert scale (1 = very satisfied to 7 = very unsatisfied).
A higher score means more symptoms.
|
Weekly, from enrollment until the last time the materials were offered (week 0, 1, 2, 3, 4).
|
|
Readiness Ruler
Time Frame: Weekly, from enrollment until the last time the materials were offered (week 0, 1, 2, 3, 4).
|
The readiness ruler is an 18-item questionnaire, aimed at measuring state-related motivation.
The readiness ruler measures readiness to change across nine eating-disorder related attitudes (restriction, weight-shape overevaluation, binge eating, vomiting, laxative use, fasting, diuretic use, weight-gain phobia, and exercise) on a scale from 1 to 10.
A higher score means more readiness to make changes.
|
Weekly, from enrollment until the last time the materials were offered (week 0, 1, 2, 3, 4).
|
|
Eating Disorder Examination Questionnaire
Time Frame: Weekly, from enrollment to the end of the study at week 5
|
Questionnaire measuring global eating-disorder severity.
The questionnaire is being used to assess severity.
The responses on the EDE-Q are also used to corroborate the provisional eating-disorder diagnosis at baseline.
The questionnaire asks about symptoms the past 28 days and a higher score means more symptoms.
The scores on each item ranges from 0 to 6. 0 = no days; 1 = 1-5 days; 2 = 6-12 days; 3 = 13-15 days; 4 = 16-22 days; 5 = 23-27 days; 6 = 28 days.
|
Weekly, from enrollment to the end of the study at week 5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance, satisfaction and engagement with the materials
Time Frame: After having received 2 and 4 weeks of psychoeducational materials (week 2 and 4).
|
Items are adjusted from the Homework Rating Scale.
Participants in the experimental condition are asked to rate how many modules they did, with 0=none, 1=a few, 2=many, 3=most, and 4=all.
The questionnaire also include items assessing level of engagement, enjoyment, perceived control over problems, and anticipated future use.
Items are scored as 0=not at all, 1=somewhat, 2=moderately, 3=very, and 4=extremely.
A higher scoremeans more engagement, enjoyment, perceived control over problems, and anticipated future use.
|
After having received 2 and 4 weeks of psychoeducational materials (week 2 and 4).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Linda Booij, Ph.D., Douglas Mental Health University Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-715
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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