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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04957498
• Collaborator: McMaster University (Other)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site: 20
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Behavioral: Guided Self-Help for Family Based Treatment; Behavioral: Family Based Treatment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Jun 18, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Recruitment Rate [Assessed through the end of recruitment (about one year)]

   Number of participants enrolled in the study per month.

2. Treatment Retention Rate [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 [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 [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 [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 [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 [Baseline through end of treatment period (up to 6 months)]

   Number of events in which a participant required hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	McMaster University	Hamilton	Ontario	Canada

Sponsors and Collaborators

• Stanford University
• McMaster University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 20, 2021

More Information

Publications

None provided.

• Responsible Party: James Dale Lock, Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents, Stanford University
• ClinicalTrials.gov Identifier: NCT04957498
• Other Study ID Numbers: 43195
• First Posted: Jul 12, 2021
• Last Update Posted: Jun 6, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by James Dale Lock, Professor of Child Psychiatry and Pediatrics in the Department of Psychiatry and Behavioral Sciences and Director of the Eating Disorder Program for Children and Adolescents, Stanford University: FBT; Family Based Treatment; Guided Self-Help
• Additional relevant MeSH terms: Anorexia; Anorexia Nervosa

Study Results

Participant Flow

Arm/Group Title	FBT-V	GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	18
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	FBT-V	GSH-FBT	Total
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.93 (1.82)	14.82 (1.86)	14.88 (1.81)
Sex: Female, Male (Count of Participants)
Female	16 80%	18 90%	34 85%
Male	4 20%	2 10%	6 15%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 5%	1 5%	2 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	17 85%	18 90%	35 87.5%
More than one race	2 10%	0 0%	2 5%
Unknown or Not Reported	0 0%	1 5%	1 2.5%
Region of Enrollment (Count of Participants)
Canada	9 45%	10 50%	19 47.5%
United States	11 55%	10 50%	21 52.5%

Outcome Measures

1. Primary Outcome

Title	Recruitment Rate
Description	Number of participants enrolled in the study per month.
Time Frame	Assessed through the end of recruitment (about one year)

Outcome Measure Data

Analysis Population Description

Since this is a feasibility study, all enrolled and randomized participants are analyzed together to report the rate that they were recruited to the study.

Arm/Group Title	Overall Sample
Arm/Group Description	Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
Measure Participants	40
Number [participants recruited per month]	2.86 14.3%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Since this is a feasibility study, all participants who were enrolled and randomized to a treatment arm are analyzed together to report the treatment retention rate.

Arm/Group Title	Overall Sample
Arm/Group Description	Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
Measure Participants	40
Count of Participants [Participants]	35 175%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Since this is a feasibility study, participants enrolled and randomized to a treatment arm are analyzed together to report the study retention rate.

Arm/Group Title	Overall Sample
Arm/Group Description	Participants enrolled and randomized to a treatment arm.
Measure Participants	40
Count of Participants [Participants]	37 185%

4. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).

Arm/Group Title	FBT-V	GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.
Measure Participants	20	18
HAQ - Helpfulness after Session 1	3.97 (3.64)	4.78 (4.75)
HAQ - Helpfulness after Session 8	6.01 (4.36)	7.77 (4.40)
HAQ - Cooperation after Session 1	11.47 (3.30)	11.91 (5.74)
HAQ - Cooperation after Session 8	13.09 (3.68)	12.38 (4.80)

5. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).

Arm/Group Title	FBT-V	GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.
Measure Participants	20	18
TSPE - Suitability of Treatment after Session 1	8.5 (1.37)	7.85 (1.98)
TSPE - Expectations of Therapy after Session 1	8.29 (1.29)	7.35 (1.77)

6. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).

Arm/Group Title	FBT-V	GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.
Measure Participants	20	18
Mean (Standard Deviation) [Sessions attended per participant]	13.32 (3.32)	11.71 (0.77)

7. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Following intent-to-treat principles, the number analyzed is based on the total N per sample in each arm, except for investigator withdrawals.

Arm/Group Title	FBT-V	GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.	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. 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.
Measure Participants	20	18
Number [events]	2	4

Adverse Events

Time Frame	Up to approximately 9 months
Arm/Group Title	FBT-V		GSH-FBT
Arm/Group Description	Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Family Based Treatment: Standard Family Based Treatment provided for up to 15 sessions.		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. 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.
All Cause Mortality
	FBT-V		GSH-FBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	FBT-V		GSH-FBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		4/20 (20%)
Psychiatric disorders
Hospitalization	1/20 (5%)	2	4/20 (20%)	4
Other (Not Including Serious) Adverse Events
	FBT-V		GSH-FBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.