Guided Self Help for Eating Disorders Implementation Study

NCT06851273 | Recruiting

• 1 other identifier: 18545
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Eating Disorders

Keywords

Anorexia nervosa; Mental disorders; Adolescent eating disorders; Psychotherapy intervention; Guided self help therapy; Family-based treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after each session throughout the 10-week protocol

Secondary Outcomes (10)

• Changes in severity of eating disorder symptoms

  at the baseline (week 0) and at the end of treatment (24 weeks)

• Changes in wait times as result of implementation approach

  at the baseline (week 0) and at the end of treatment (24 weeks)

• Changes in severity of depressive symptoms

  at the baseline (week 0) and at the end of treatment (24 weeks)

• Changes in anxiety symptoms

  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)

  at the baseline (week 0) and at the end of treatment (24 weeks)

Other Outcomes (2)

• The experience of parents/families 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

  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.

Study Arms (1)

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.

Behavioral: Guided Self Help Family Based Therapy (GSH FBT)

Interventions

Guided Self Help Family Based Therapy (GSH FBT) BEHAVIORAL

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.

Parents who have a child with anorexia nervosa

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41199206 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Mental Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer Couturier, MSc, MD

CONTACT

905-521-2100; coutur@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 28, 2025
• Study Start: April 28, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)