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

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957498
• Other study ID #: 43195
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.
• Family Based Treatment
Standard Family Based Treatment provided for up to 15 sessions.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	McMaster University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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