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

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Family Based Treatment; Behavioral: Guided Self-Help for Family Based Treatment

• Registration Number: NCT04957498
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2021-06-18
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-12
• Study Completion: 2021-08-31
• Results First Submitted: 2021-09-21
• Results First Submitted QC: 2021-11-03
• Results First Posted: 2021-12-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FBT	Family Based Treatment	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
FBT-GSH	Guided Self-Help for Family Based Treatment	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.

Primary Outcome Measures

Name	Time	Method
Treatment Retention Rate	Up to 6 months	The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Number of Treatment Sessions Attended	Through end of treatment (up to approximately 6 months)	The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
Recruitment Rate	Assessed through the end of recruitment (about one year)	Number of participants enrolled in the study per month.
Treatment Acceptability Ratings	Session 1 (approximately 5 minutes to complete questionnaire)	To assess treatment acceptability, the study used the Therapist Suitability and Patient Expectancy measure (TSPE). The TSPE was administered to parents after session 1. The scale is measured from 0-10 (with 0 as the lowest rating and 10 as the highest rating). The average score was calculated if more than one parent responded. A higher score on the TSPE indicates a better outcome.
Serious Adverse Events	Baseline through end of treatment period (up to 6 months)	Number of events in which a participant required hospitalization
Study Retention Rate	Up to 9 months	The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.

Trial Locations

Locations (2)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Stanford University; 🇺🇸 Stanford, California, United States