Trial Outcomes & Findings for Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa (NCT NCT04957498)
NCT ID: NCT04957498
Last Updated: 2022-06-06
Results Overview
Number of participants enrolled in the study per month.
COMPLETED
NA
40 participants
Assessed through the end of recruitment (about one year)
2022-06-06
Participant Flow
Participant milestones
| Measure |
FBT-V
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.
|
GSH-FBT
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
FBT-V
n=20 Participants
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.
|
GSH-FBT
n=20 Participants
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
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
14.93 years
STANDARD_DEVIATION 1.82 • n=93 Participants
|
14.82 years
STANDARD_DEVIATION 1.86 • n=4 Participants
|
14.88 years
STANDARD_DEVIATION 1.81 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Assessed through the end of recruitment (about one year)Population: 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.
Number of participants enrolled in the study per month.
Outcome measures
| Measure |
Overall Sample
n=40 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
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.
|
|---|---|---|
|
Recruitment Rate
|
2.86 participants recruited per month
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: 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.
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Outcome measures
| Measure |
Overall Sample
n=40 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
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.
|
|---|---|---|
|
Treatment Retention Rate
|
35 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: Since this is a feasibility study, participants enrolled and randomized to a treatment arm are analyzed together to report the study retention rate.
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
Outcome measures
| Measure |
Overall Sample
n=40 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
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.
|
|---|---|---|
|
Study Retention Rate
|
37 Participants
|
—
|
PRIMARY outcome
Timeframe: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
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.
Outcome measures
| Measure |
Overall Sample
n=20 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
n=18 Participants
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.
|
|---|---|---|
|
Treatment Acceptability Ratings
HAQ - Helpfulness after Session 1
|
3.97 score on a scale
Standard Deviation 3.64
|
4.78 score on a scale
Standard Deviation 4.75
|
|
Treatment Acceptability Ratings
HAQ - Helpfulness after Session 8
|
6.01 score on a scale
Standard Deviation 4.36
|
7.77 score on a scale
Standard Deviation 4.40
|
|
Treatment Acceptability Ratings
HAQ - Cooperation after Session 1
|
11.47 score on a scale
Standard Deviation 3.30
|
11.91 score on a scale
Standard Deviation 5.74
|
|
Treatment Acceptability Ratings
HAQ - Cooperation after Session 8
|
13.09 score on a scale
Standard Deviation 3.68
|
12.38 score on a scale
Standard Deviation 4.80
|
PRIMARY outcome
Timeframe: Session 1 (approximately 5 minutes to complete questionnaire)Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
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.
Outcome measures
| Measure |
Overall Sample
n=20 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
n=18 Participants
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.
|
|---|---|---|
|
Treatment Acceptability Ratings
TSPE - Suitability of Treatment after Session 1
|
8.5 score on a scale
Standard Deviation 1.37
|
7.85 score on a scale
Standard Deviation 1.98
|
|
Treatment Acceptability Ratings
TSPE - Expectations of Therapy after Session 1
|
8.29 score on a scale
Standard Deviation 1.29
|
7.35 score on a scale
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: Through end of treatment (up to approximately 6 months)Population: Intent-to-treat population (excluding participants who were withdrawn from the study per investigator decision).
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
Outcome measures
| Measure |
Overall Sample
n=20 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
n=18 Participants
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.
|
|---|---|---|
|
Number of Treatment Sessions Attended
|
13.32 Sessions attended per participant
Standard Deviation 3.32
|
11.71 Sessions attended per participant
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: Baseline through end of treatment period (up to 6 months)Population: Following intent-to-treat principles, the number analyzed is based on the total N per sample in each arm, except for investigator withdrawals.
Number of events in which a participant required hospitalization
Outcome measures
| Measure |
Overall Sample
n=20 Participants
Participants enrolled and randomized to a treatment arm (FBT-V or GSH-FBT).
|
GSH-FBT
n=18 Participants
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.
|
|---|---|---|
|
Serious Adverse Events
|
2 events
|
4 events
|
Adverse Events
FBT-V
GSH-FBT
Serious adverse events
| Measure |
FBT-V
n=20 participants at risk
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.
|
GSH-FBT
n=20 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
5.0%
1/20 • Number of events 2 • Up to approximately 9 months
|
20.0%
4/20 • Number of events 4 • Up to approximately 9 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Lock
Stanford University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place