The Acceptability and Effectiveness of Receiving a Low-intensity Self-guided Psychoeducational Intervention for Individuals Waitlisted for Specialized Eating-disorder Treatment

December 20, 2025 updated by: Linda Booij, Douglas Mental Health University Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Instititute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Psycho-education
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.
Behavioral: No psycho-education
Does not receive any psychoeducational materials, while on the waitlist for treatment [control condition].

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Douglas Mental Health University Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda Booij, Ph.D., Douglas Mental Health University Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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