Eating DisordersGSHimplementNCT06851273
Guided Self Help for Eating Disorders Implementation Study
A study testing Guided Self Help Family Based Therapy (GSH FBT) in people with Eating Disorders, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Guided Self Help Family Based Therapy (GSH FBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Jennifer Couturier, MSc, MD, 905-521-2100 ext. 76008, coutur@mcmaster.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Eating Disorders
- Being tested
- Guided Self Help Family Based Therapy (GSH FBT)
- Keywords
- Anorexia nervosa, Mental disorders, Adolescent eating disorders, Psychotherapy intervention, Guided self help therapy, Family-based treatment
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self Help Family Based Therapy (GSH FBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents who have a child with anorexia nervosa | Experimental | 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. Receives: Behavioral: Guided Self Help Family Based Therapy (GSH FBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation success at participating sites, as measured by fidelity to GSH FBT model
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.
Measured: Immediately after each session throughout the 10-week protocol
Secondary outcomes (10)
Changes in severity of eating disorder symptoms
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in wait times as result of implementation approach
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in severity of depressive symptoms
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in anxiety symptoms
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.
Measured: 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)
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).
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in obsessional thinking and compulsive behaviours
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).
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Changes in parental self-efficacy
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).
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Provider's readiness for change
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Providers' attitudes towards evidence-based practice
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Provider's confidence in ability to deliver intervention
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.
Measured: at the baseline (week 0) and at the end of treatment (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start28 Apr 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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 Eating DisordersStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jennifer Couturier, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851273
- Sponsor's protocol ID
- 18545
- Acronym
- GSHimplement
- Status last verified
- May 2026
- First submitted
- 12 Feb 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Couturier J, Smith J, Nicula M, Nella E, Yanover T, Agostino H, Annema S, Boman J, Bond J, Coelho JS, Coolen AM, Datta N, Dimitropoulos G, Ford C, Isserlin L, Johnson N, Jones S, Katzman D, Kelly B, Keshen A, Kimber M, Kumar S, Kurji A, Lacroix E, Markland A, Matheson B, McVey G, McQuillan B, Norris M, Obeid N, Phillips S, Preskow W, Rodrigues A, Smith S, Soroka C, Spettigue W, Webb C, Wournell J, Lock JD. National implementation of guided self-help family-based treatment for youth with eating disorders: a study protocol. BMC Psychiatry. 2025 Nov 6;25(1):1066. doi: 10.1186/s12888-025-07545-1.
PubMed 41199206
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Implementation of Highly Efficient Evidence-Informed Treatment for Youth With Eating Disorders
- ClinicalTrials.gov ID
- NCT06851273
- Acronym / sponsor ID
- GSHimplement / 18545
- Conditions
- Eating Disorders
- Keywords
- Anorexia nervosa, Mental disorders, Adolescent eating disorders, Psychotherapy intervention, Guided self help therapy, Family-based treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents who have a child with anorexia nervosa | Experimental | Behavioral: Guided Self Help Family Based Therapy (GSH FBT)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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Parents who have a child with anorexia nervosa |
Primary outcome
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.
10 secondary outcomes
Changes in severity of eating disorder symptoms
Time frame: at the baseline (week 0) and at the end of treatment (24 weeks)
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 severity of depressive symptoms
Time frame: 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 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 obsessional thinking and compulsive behaviours
Time frame: 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)
Provider's readiness for change
Time frame: 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's confidence in ability to deliver intervention
Time frame: at the baseline (week 0) and at the end of treatment (24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 41199206Couturier J, Smith J, Nicula M, Nella E, Yanover T, Agostino H, Annema S, Boman J, Bond J, Coelho JS, Coolen AM, Datta N, Dimitropoulos G, Ford C, Isserlin L, Johnson N, Jones S, Katzman D, Kelly B, Keshen A, Kimber M, Kumar S, Kurji A, Lacroix E, Markland A, Matheson B, McVey G, McQuillan B, Norris M, Obeid N, Phillips S, Preskow W, Rodrigues A, Smith S, Soroka C, Spettigue W, Webb C, Wournell J, Lock JD. National implementation of guided self-help family-based treatment for youth with eating disorders: a study protocol. BMC Psychiatry. 2025 Nov 6;25(1):1066. doi: 10.1186/s12888-025-07545-1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self Help Family Based Therapy (GSH FBT) in people with Eating Disorders, run by McMaster 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 8 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Couturier, MSc, MD (905-521-2100 ext. 76008, coutur@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation success at participating sites, as measured by fidelity to GSH FBT model (time frame: Immediately after each session throughout the 10-week protocol). 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 NCT06851273, 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 7 May 2026.