Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anorexia Nervosa
- Sponsor
- Stanford University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Ratio of therapist hours to %EBW change
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
Investigators
James Dale Lock
Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Participants are 12-18 years of age
- •Participants live with a family (some families may contain only one parent)
- •Family members fluently speak and read English and have access to a computer with internet
- •Participants meet DSM-5 criteria for AN (both subtypes)
- •EBW above 75%
- •Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
- •Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study.
- •Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.
Exclusion Criteria
- •Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
Outcomes
Primary Outcomes
Ratio of therapist hours to %EBW change
Time Frame: Assessed from baseline through end of treatment (EOT)
The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.
Secondary Outcomes
- Beck Depression Inventory (BDI)(These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up))
- Beck Anxiety Inventory (BAI)(Baseline, sessions 2, 4, 6, 8, and EOT)
- Eating Disorder Examination (EDE)(Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up)