Guided Self Help for Eating Disorders Implementation Study

Not Applicable

Not yet recruiting

• Conditions: Eating Disorders

• Registration Number: NCT06851273
• Lead Sponsor: McMaster University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-04-01
• Primary Completion: 2026-08-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implementation success at participating sites, as measured by fidelity to GSH FBT model	Immediately after each session throughout the 10-week protocol	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.

Secondary Outcome Measures

Name	Time	Method
Changes in wait times as result of implementation approach	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in wait time for service will be assessed by asking site administrators to provide wait time for service (in days) and an estimate of number of adolescents waiting for eating disorder services.
Changes in severity of eating disorder symptoms	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in severity of eating disorder symptoms will be assessed using the Eating Disorder Examination Questionnaire (EDEQ), a 28-item standardized questionnaire that measures the severity of symptoms of eating disorders. The EDEQ is scored using a 7-point, forced-choice rating scale (0-6) with scores of 4 or higher indicative of clinical range and severity of the illness.
Changes in severity of depressive symptoms	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in severity of depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item questionnaire used to measure the severity of depressive symptoms. Minimum score is 0, maximum score is 63.
Changes in anxiety symptoms	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in severity of anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item questionnaire used to measure the severity of anxiety symptoms. Minimum score is 0, maximum score is 63.
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)	Changes in severity of obsessional thinking and compulsive behaviours (linked to eating disorder symptomatology) will be assessed using the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS), It includes a comprehensive checklist of 21 preoccupations and 44 rituals related to food, eating, weight, shape, and appearance. Each item is rated on a scale from 0 to 4, with 0 indicating no symptoms and 4 indicating very severe symptoms. The total score is the sum of these individual ratings. Therefore, the minimum possible score is 0 (indicating no symptoms), and the maximum possible score is 260 (indicating the most severe symptoms).
Changes in obsessional thinking and compulsive behaviours	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in severity of obsessional thinking and compulsive behaviours will be assessed using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS-II), a self-report questionnaire assessing obsessions and compulsions separately from eating disorder symptomatology, will also be used to assess this outcome. The total score ranges from 0 (least severe) to 50 (most severe).
Changes in parental self-efficacy	at the baseline (week 0) and at the end of treatment (24 weeks)	Changes in parental self-efficacy will be assessed using the "Parents versus Eating Disorder Scale" (PvED), a 7-item measure assessing parental self-efficacy related to re-feeding their child with an eating disorder. Scores range from 7 (least severe) to 35 (most severe).
Provider's readiness for change	at the baseline (week 0) and at the end of treatment (24 weeks)	Provider individual readiness for change will be evaluated using the Brief Individual Readiness for Change Scale (BIRCS), administered to therapist-coaches. Minimum score is 0, maximum score is 20.
Providers' attitudes towards evidence-based practice	at the baseline (week 0) and at the end of treatment (24 weeks)	Provider attitudes about evidence-based practice will be assessed using the Evidence Based Practice Attitudes Scale (EBPAS), administered to therapist-coaches. Minimum score for each subscale is 0, maximum score for each subscale is 4.
Provider's confidence in ability to deliver intervention	at the baseline (week 0) and at the end of treatment (24 weeks)	Confidence related to the intervention will be assessed by administering an adapted version of the Perceived Attributes of the Principles of Effectiveness Scale (MPAQ) to therapist-coaches. The minimum score is 18, the maximum score is 90.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada