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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Guided Self-Help for Family Based Treatment
Family Based Treatment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring FBT, Family Based Treatment, Guided Self-Help

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University
  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

FBT

FBT-GSH

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Recruitment Rate
Number of participants enrolled in the study per month.
Treatment Retention Rate
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Study Retention Rate
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
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.
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.
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.
Serious Adverse Events
Number of events in which a participant required hospitalization

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
May 11, 2022
Sponsor
Stanford University
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04957498
Brief Title
Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Official Title
Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
FBT, Family Based Treatment, Guided Self-Help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FBT
Arm Type
Active Comparator
Arm Description
Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
Arm Title
FBT-GSH
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Help for Family Based Treatment
Other Intervention Name(s)
FBT-GSH
Intervention Description
A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment
Other Intervention Name(s)
FBT
Intervention Description
Standard Family Based Treatment provided for up to 15 sessions.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Number of participants enrolled in the study per month.
Time Frame
Assessed through the end of recruitment (about one year)
Title
Treatment Retention Rate
Description
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
Title
Study Retention Rate
Description
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
Title
Treatment Acceptability Ratings
Description
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)
Title
Treatment Acceptability Ratings
Description
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)
Title
Number of Treatment Sessions Attended
Description
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
Time Frame
Through end of treatment (up to approximately 6 months)
Title
Serious Adverse Events
Description
Number of events in which a participant required hospitalization
Time Frame
Baseline through end of treatment period (up to 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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