Guided Self Help for Eating Disorders Implementation Study (GSHimplement)

May 1, 2026 updated by: Jennifer Couturier, McMaster University

National Implementation of Highly Efficient Evidence-Informed Treatment for Youth With Eating Disorders

Eating disorders are amongst the most understudied illnesses affecting young women in Canada. Further, mortality rates are amongst the highest of all psychiatric illnesses. Despite their high prevalence and mortality rates, research into adolescent eating disorders is underfunded in Canada. In addition to the problem of research underfunding, healthcare system underfunding exists - creating long waiting lists and fragmented care for children and youth with eating disorders. More efficient treatments are urgently needed to reduce wait times and provide expedited care to adolescents on eating disorder waitlists. The current study aims to assess whether implementing a virtual parent-lead therapy, Guided Self Help Family-Based Therapy (GSH FBT) might alleviate wait times for eating disorder services and also reduce eating disorder symptomatology in young people with anorexia nervosa. This study also aims to determine the experiences of both families and medical teams of GSH FBT implementation as an intervention.

Study Overview

Status

Status

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

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.

Detailed Description

The most widely used evidence-based treatment for children and adolescents with eating disorders is Family-Based Treatment (FBT). Similarly, Guided Self-Help FBT (GSH FBT) is a virtual treatment, adapted using FBT principles, that involves a therapist "coach" and a video platform for parents. Therapeutic challenges such as treatment fidelity could be partially mitigated with a model, such as GSH FBT, in which essential material is delivered by video or written material, standardizing the treatment and ensuring that key components are delivered. Given the surging wait list times for adolescent eating disorder treatment, GSH FBT is emerging as a promising, more efficient alternative to longer-term FBT and FBT-V. This study is aimed at examining the implementation of GSH FBT for pediatric patients with eating disorders across nine provinces in Canada using a mixed methods design. To implement this new model of care, the investigators will use implementation teams at each site along with GSH FBT provider training and consultation. The investigators will evaluate the implementation approach using qualitative and quantitative methods including fidelity assessments, examination of wait times, patient, family, and provider outcomes, as well as the overall experience of the implementation of the intervention. Experience of implementation will be assessed using qualitative measures such as semi-structured interviews and focus groups.

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 (Estimated)

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.
90

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jennifer Couturier, MSc, MD
  • Phone Number: 76008 905-521-2100
  • Email: coutur@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • Recruiting
        • McMaster University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Family including an adolescent with a confirmed diagnosis of Anorexia nervosa according to DSM-5-TR criteria.
  • Access to computer and internet connection
  • Have the capacity to speak, write, and understand English or French
  • Therapist/coaches are licensed mental health clinician with experience in eating disorder treatment

Exclusion Criteria:

  • Adolescent has a current physical or mental disorder that requires hospitalization and/or prohibits the use of psychotherapy
  • Adolescent has a current dependence on drugs or alcohol
  • Adolescent has a current physical condition known to influence weight or eating (pregnancy, diabetes mellitus)
  • Adolescent has expected body weight of less than 75%
  • Adolescent/family has undergone four or more sessions of FBT for anorexia nervosa at any time
  • Does not have the capacity to speak, write, and understand English or French
  • Does not have access to computer and internet connection
  • Professionals are not licensed mental health professionals with experience in eating disorder treatment.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group 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: Parents who have a child with anorexia nervosa
Each participant will receive a series of pre-recorded videos, an electric scale, and a therapy manual ("Help Your Teenager Beat an Eating Disorder"). This will include content on empowering parents to renourish their child and interrupt binge/purge behaviors.
Behavioral: Guided Self Help Family Based Therapy (GSH FBT)
Each family will participate in ten virtual sessions of GSH FBT with a trained GSH practitioner local to their provincial study site. Parents will meet their coach for a 60-minute onboarding session where the parents/caregivers are familiarized with the video platform used in treatment. Then, the treatment consists of ten virtual 20-minute sessions over 6 months. In GSH FBT, the parents weigh the adolescent patient prior to the session, on the same day as the session, and report the weight to the coach. Throughout treatment, parents have access to an online platform with a series of videos that outline the core components of FBT: the urgency to act, parental empowerment, medical complications, strategies to use during and after mealtime, and how to externalize the illness. In line with GSH approaches, coach-therapists direct parents to watch or review videos and text content rather than directly affecting behavioral change.

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
Implementation success at participating sites, as measured by fidelity to GSH FBT model
Time Frame: Immediately after each session throughout the 10-week protocol
Fidelity of therapists will be measured via administration of a self-reporting fidelity questionnaire piloted in a previous GSH FBT feasibility study. This questionnaire includes nine yes/no questions that gauge whether the therapist was adherent to GSH FBT principles: 1) ensuring only parents are present; 2) ensuring the adolescent is not present; 3) asking parents questions/comments about course materials; 4) avoiding direct orchestration of behavioural change; 5) referencing course materials during the session; 6) focusing the session on treatment; 7) assigning homework appropriately; and 8) & 9) verifying session length. Videos will also be monitored regularly for fidelity via expert review.
Immediately after each session throughout the 10-week protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in wait times as result of implementation approach
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in wait time for service will be assessed by asking site administrators to provide wait time for service (in days) and an estimate of number of adolescents waiting for eating disorder services.
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of eating disorder symptoms
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire (EDEQ), a 28-item standardized questionnaire that measures the severity of symptoms of eating disorders. The EDEQ is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range and severity of the illness.
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of depressive symptoms
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item questionnaire used to measure the severity of depressive symptoms. Minimum score is 0, maximum score is 63.
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in anxiety symptoms
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item questionnaire used to measure the severity of anxiety symptoms. Minimum score is 0, maximum score is 63.
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in obsessional thinking and compulsive behaviours (linked to eating disorder symptomatology)
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of obsessional thinking and compulsive behaviours (linked to eating disorder symptomatology) will be assessed using the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS), It includes a comprehensive checklist of 21 preoccupations and 44 rituals related to food, eating, weight, shape, and appearance. Each item is rated on a scale from 0 to 4, with 0 indicating no symptoms and 4 indicating very severe symptoms. The total score is the sum of these individual ratings. Therefore, the minimum possible score is 0 (indicating no symptoms), and the maximum possible score is 260 (indicating the most severe symptoms).
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in obsessional thinking and compulsive behaviours
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of obsessional thinking and compulsive behaviours will be assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS-II), a self-report questionnaire assessing obsessions and compulsions separately from eating disorder symptomatology, will also be used to assess this outcome. The total score ranges from 0 (least severe) to 50 (most severe).
at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in parental self-efficacy
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in parental self-efficacy will be assessed using the "Parents versus Eating Disorder Scale" (PvED), a 7-item measure assessing parental self-efficacy related to re-feeding their child with an eating disorder. Scores range from 7 (least severe) to 35 (most severe).
at the baseline (week 0) and at the end of treatment (24 weeks)
Provider's readiness for change
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Provider individual readiness for change will be evaluated using the Brief Individual Readiness for Change Scale (BIRCS), administered to therapist-coaches. Minimum score is 0, maximum score is 20.
at the baseline (week 0) and at the end of treatment (24 weeks)
Providers' attitudes towards evidence-based practice
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Provider attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS), administered to therapist-coaches. Minimum score for each subscale is 0, maximum score for each subscale is 4.
at the baseline (week 0) and at the end of treatment (24 weeks)
Provider's confidence in ability to deliver intervention
Time Frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAQ) to therapist-coaches. The minimum score is 18, the maximum score is 90.
at the baseline (week 0) and at the end of treatment (24 weeks)

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
The experience of parents/families participating in GSH FBT treatment
Time Frame: Interviews with families will be scheduled within two weeks of their provider notifying us that their final treatment session has occurred.
Semi-structured interviews will be used to elicit qualitative descriptions of experiences of each family participating in GSH FBT treatment.
Interviews with families will be scheduled within two weeks of their provider notifying us that their final treatment session has occurred.
Implementation teams' experiences of GSH FBT treatment and its implementation
Time Frame: Focus groups with a site will occur within two weeks of when the investigators have been notified that all GSH FBT sessions have been completed at the site.
Semi-structured focus groups with each site's implementation team will be used to elicit qualitative descriptions of their experiences of GSH FBT treatment and implementation.
Focus groups with a site will occur within two weeks of when the investigators have been notified that all GSH FBT sessions have been completed at the site.

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.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
April 28, 2026

Primary Completion (Estimated)

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.
August 30, 2027

Study Completion (Estimated)

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.
December 30, 2027

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).
February 12, 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.
February 26, 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.
February 28, 2025

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.
May 7, 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.
May 1, 2026

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.
May 1, 2026

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.
  • 18545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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