Guided Self Help for Eating Disorders Implementation Study

NCT ID: NCT06851273

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-07-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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 Teen Beat an Eating Disorder"). This will include content on empowering parents to renourish their child and interrupt binge/purge behaviors.

Group Type: EXPERIMENTAL

Guided Self Help Family Based Therapy (GSH FBT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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
• 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
• Does not have access to computer and internet connection
• Professionals are not licensed mental health professionals with experience in eating disorder treatment.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Couturier

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Jennifer Couturier, MSc, MD

Role: CONTACT

coutur@mcmaster.ca

905-521-2100 ext. 76008

Facility Contacts

Jennifer Couturier, MSc, MD

Role: primary

coutur@mcmaster.ca

905-521-2100 ext. 76008

Other Identifiers

18545

Identifier Type: -

Identifier Source: org_study_id