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NCT Number: NCT04957498

Feasibility Study 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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Associated physical illness that necessitates hospitalization
  • Psychotic illness in any form, mental retardation, autism, or any other mental illness that would interfere with the use of psychotherapy.
  • Current dependence on drugs or alcohol
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Previous (5 or more sessions of) or current FBT-AN
  • 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.
  • Current weight is less than 75% or above 88% of expected weight given age and height.

Treatment and study plan

Guided Self-Help for Family Based Treatment

Behavioral

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

Family Based Treatment

Behavioral

Standard Family Based Treatment provided for up to 15 sessions.

Other names: FBT

Primary outcomes

  1. Recruitment Rate

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

    Number of participants enrolled in the study per month.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Serious Adverse Events

    Time frame: Baseline through end of treatment period (up to 6 months)

    Number of events in which a participant required hospitalization

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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