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

May 11, 2022 updated by: James Dale Lock, Stanford University

Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FBT
Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
Behavioral: Family Based Treatment
Standard Family Based Treatment provided for up to 15 sessions.
Other Names:
  • FBT
Experimental: FBT-GSH
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.
Behavioral: Guided Self-Help for Family Based Treatment
A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
Other Names:
  • FBT-GSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Assessed through the end of recruitment (about one year)
Number of participants enrolled in the study per month.
Assessed through the end of recruitment (about one year)
Treatment Retention Rate
Time Frame: Up to 6 months
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Up to 6 months
Study Retention Rate
Time Frame: Up to 9 months
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
Up to 9 months
Treatment Acceptability Ratings
Time Frame: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
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.
Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
Treatment Acceptability Ratings
Time Frame: 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.
Session 1 (approximately 5 minutes to complete questionnaire)
Number of Treatment Sessions Attended
Time Frame: 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.
Through end of treatment (up to approximately 6 months)
Serious Adverse Events
Time Frame: Baseline through end of treatment period (up to 6 months)
Number of events in which a participant required hospitalization
Baseline through end of treatment period (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

June 18, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43195

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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