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

Stanford University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anorexia Nervosa

Interventions

Guided Self-Help for Family Based TreatmentBEHAVIORAL

A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.

Family Based TreatmentBEHAVIORAL

Standard Family Based Treatment provided for up to 15 sessions.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Stanford University

Stanford, California, United States

McMaster University

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment Rate

Number of participants enrolled in the study per month.

Time frame: Assessed through the end of recruitment (about one year)

Treatment Retention Rate

The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).

Time frame: Up to 6 months

Study Retention Rate

The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.

Time frame: Up to 9 months

Treatment Acceptability Ratings

To assess treatment acceptability, the study used the Cooperation and Helpfulness sub-scales of the Helping Alliance Questionnaire (HAQ). The HAQ was administered to parents after session 1 and 8. The subscales, Helpfulness and Cooperation, are scored on a Likert scale from "Strongly feels it's true" (+3) to "Strongly feel it's not true" (-3). The sub-scales' total scores ranges are 15- to 15 for Helpfulness and -18 to 18 for Cooperation. A higher score indicates a better outcome. The average score was calculated if more than one parent responded.

Time frame: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)

Treatment Acceptability Ratings

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.

Time frame: Session 1 (approximately 5 minutes to complete questionnaire)

Number of Treatment Sessions Attended

The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.