Guided Self Help for Eating Disorders Implementation Study

Official title

National Implementation of Highly Efficient Evidence-Informed Treatment for Youth With Eating Disorders

Overview

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.

Interventions

• Behavioral 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 th

Primary outcome measures

• Implementation success at participating sites, as measured by fidelity to GSH FBT model [Time frame: Immediately after each session throughout the 10-week protocol]

Secondary outcome measures (10)

• 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)]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Canada · 1 center

• McMaster University — Hamilton

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, PMID 41199206

Identifiers

NCT: NCT06851273 · 18545

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗