Guided Self Help for Eating Disorders Implementation Study

ConditionEating Disorders

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-100

SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Single group

Treatments tested in this trial

Guided Self Help Family Based Therapy (GSH FBT)
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.

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: Parents who have a child with anorexia nervosaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Implementation success at participating sites, as measured by fidelity to GSH FBT model

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.

Time frame

Immediately after each session throughout the 10-week protocol

Secondary outcomes

Changes in severity of eating disorder symptoms

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.

Time frame

at the baseline (week 0) and at the end of treatment (24 weeks)

Changes in wait times as result of implementation approach

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.

Time frame

at the baseline (week 0) and at the end of treatment (24 weeks)

Changes in severity of depressive symptoms

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.

Time frame

at the baseline (week 0) and at the end of treatment (24 weeks)

Changes in anxiety symptoms

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.

Time frame

at the baseline (week 0) and at the end of treatment (24 weeks)

Other outcomes

The experience of parents/families participating in GSH FBT treatment

Semi-structured interviews will be used to elicit qualitative descriptions of experiences of each family participating in GSH FBT treatment.

Time frame

Interviews with families will be scheduled within two weeks of their provider notifying us that their final treatment session has occurred.

Implementation teams' experiences of GSH FBT treatment and its implementation

Semi-structured focus groups with each site's implementation team will be used to elicit qualitative descriptions of their experiences of GSH FBT treatment and implementation.

Time frame

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.

Sponsors and contacts

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McMaster University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

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