Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa

Stanford University

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Behavioral: Family Based Treatment; Behavioral: Guided Self-Help for Family Based Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04957498

43195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

FBT

Active Comparator group

Description:

Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.

Treatment:

Behavioral: Family Based Treatment

FBT-GSH

Experimental group

Description:

Family Based Treatment Guided Self-Help (FBT-GSH) includes an online website with educational videos, readings, discussion groups, and journals. Parents assigned to this arm will have up to 12 coaching sessions (20-30 minutes) with a trained therapist.

Treatment:

Behavioral: Guided Self-Help for Family Based Treatment