Clinical trial NCT06851273: Guided Self Help for Eating Disorders Implementation Study
Official title: National Implementation of Highly Efficient Evidence-Informed Treatment for Youth with Eating Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eating Disorders
Keywords: Anorexia nervosa
Mental disorders
Adolescent eating disorders
Psychotherapy intervention
Guided self help therapy
Family-based treatment
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2025-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Implementation success at participating sites, as measured by fidelity to GSH FBT model
timeFrame: Immediately after each session throughout the 10-week protocol
Secondary outcomes:
measure: Changes in wait times as result of implementation approach
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in severity of eating disorder symptoms
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in severity of depressive symptoms
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in anxiety symptoms
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in obsessional thinking and compulsive behaviours (linked to eating disorder symptomatology)
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in obsessional thinking and compulsive behaviours
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Changes in parental self-efficacy
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Provider's readiness for change
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Providers' attitudes towards evidence-based practice
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
measure: Provider's confidence in ability to deliver intervention
timeFrame: at the baseline (week 0) and at the end of treatment (24 weeks)
Other outcomes:
measure: The experience of parents/families participating in GSH FBT treatment
timeFrame: Interviews with families will be scheduled within two weeks of their provider notifying us that their final treatment session has occurred.
measure: Implementation teams' experiences of GSH FBT treatment and its implementation
timeFrame: 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.
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: