Recruiting

GSH FBT

Sponsor:

McMaster University

Code:

NCT06851273

Conditions

Eating Disorders

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

Guided Self Help Family Based Therapy (GSH FBT)

Study Details

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

Study ID

NCT06851273

Start date

Apr 28, 2026

Status verified date

May, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

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 ]

Central Contacts and Locations

Central contacts

Jennifer Couturier, MSc, MD

905-521-2100coutur@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Jennifer Couturier, MSc, MD

905-521-2100coutur@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-05-07.