Clinical trial NCT04957498: Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Official title: Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: FBT
Family Based Treatment
Guided Self-Help
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2021-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines a parent only Guided Self-Help for Family Based Treatment (GSH-FBT) for adolescents between the ages of 12 and 18 diagnosed with Anorexia Nervosa. Preliminary data collected in a previous study suggest that a Guided Parental Self-Help Version of FBT (GSH-FBT) has similar outcomes as therapist provided FBT.

Detailed description: In this study, families will be randomized to either receive 12 weekly online sessions of Guided Self-Help for Family Based Treatment (GSH-FBT), or 15 sessions of online, professionally delivered, standard FBT over the course of 6 months. Potential subjects will be recruited from Stanford University, McMaster University, other local medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview during which the investigators will conduct interviews and collect questionnaire measures. Participants will complete a follow-up interview at the end of treatment and 3-month after end of treatment.

Eligibility criteria: Inclusion Criteria:

1. Participants are 12-18 years of age
2. Participants live with a family (some families may contain only one parent)
3. Family members fluently speak and read English and have access to a computer with internet
4. Participants meet DSM-5 criteria for AN (both subtypes)
5. IBW between 75% and 88%
6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine
7. Participants are not engaged in another individual or family based psychotherapy trial during the duration of treatment sessions in the study.
8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking.

Exclusion Criteria:

1. Associated physical illness that necessitates hospitalization
2. Psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy.
3. Current dependence on drugs or alcohol
4. Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
5. Previous (5 or more sessions of) or current FBT-AN
6. Participants and family members do not have an adequate understanding of spoken English and are not able to speak and read English in order to participate in family therapy and the assessments.
7. Current weight is less than 75% or above 88% of expected weight given age and height.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Assessed through the end of recruitment (about one year)
measure: Treatment Retention Rate
timeFrame: Up to 6 months
measure: Study Retention Rate
timeFrame: Up to 9 months
measure: Treatment Acceptability Ratings
timeFrame: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
measure: Treatment Acceptability Ratings
timeFrame: Session 1 (approximately 5 minutes to complete questionnaire)
measure: Number of Treatment Sessions Attended
timeFrame: Through end of treatment (up to approximately 6 months)
measure: Serious Adverse Events
timeFrame: Baseline through end of treatment period (up to 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: