An interventional study of Guided Self-Help for Family Based Treatment and Family Based Treatment in Anorexia Nervosa, sponsored by Stanford University. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
462 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 311 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist.
Behavioral: Family Based Treatment
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.
Also known as: FBT-GSH
Standard Family Based Treatment provided for up to 15 sessions.
Also known as: FBT
Recruitment Rate
Number of participants enrolled in the study per month.
Time frame: Assessed through the end of recruitment (about one year)
Treatment Retention Rate
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
Study Retention Rate
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
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.
Time frame: Session 1 and Session 8 (approximately 5 minutes to complete questionnaire)
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.
Time frame: Session 1 (approximately 5 minutes to complete questionnaire)
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.
Time frame: Through end of treatment (up to approximately 6 months)
Serious Adverse Events
Number of events in which a participant required hospitalization
Time frame: Baseline through end of treatment period (up to 6 months)
| Milestone | FBT-V | GSH-FBT |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 18 |
| Not completed | 1 | 2 |
Number of participants enrolled in the study per month.
| participants recruited per month | Overall Sample |
|---|---|
| Recruitment Rate | 2.86 |
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
| Participants | Overall Sample |
|---|---|
| Treatment Retention Rate | 35 |
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
| Participants | Overall Sample |
|---|---|
| Study Retention Rate | 37 |
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.
| score on a scale | FBT-V | GSH-FBT |
|---|---|---|
| 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 |
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.
| score on a scale | FBT-V | GSH-FBT |
|---|---|---|
| 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 |
The number of sessions completed by the the participant with the client in treatment is the actual, not planned, number of sessions actually conducted.
| Sessions attended per participant | FBT-V | GSH-FBT |
|---|---|---|
| Number of Treatment Sessions Attended | 13.32 ± 3.32 | 11.71 ± 0.77 |
Number of events in which a participant required hospitalization
| events | FBT-V | GSH-FBT |
|---|---|---|
| Serious Adverse Events | 2 | 4 |
Collected over Up to approximately 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FBT-V | 0/20 (0%) | 1/20 (5%) | 0/20 (0%) |
| GSH-FBT | 0/20 (0%) | 4/20 (20%) | 0/20 (0%) |
| Event | FBT-V | GSH-FBT |
|---|---|---|
| HospitalizationPsychiatric disorders | 1/20 | 4/20 |
| Age, Categorical(Participants) | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| <=18 years | 20 | 20 | 40 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| Mean | 14.93 ± 1.82 | 14.82 ± 1.86 | 14.88 ± 1.81 |
| Sex: Female, Male(Participants) | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| Female | 16 | 18 | 34 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 17 | 18 | 35 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(Participants) | FBT-V | GSH-FBT | Total |
|---|---|---|---|
| Canada | 9 | 10 | 19 |
| United States | 11 | 10 | 21 |
Documents are hosted by the registry — open the source record to download them.
Ran from Aug 2019 to primary completion in Jun 2021, 22 months.
Results were first posted in Dec 2021, 5 months after primary completion.
Of 153 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 61. This study's 22 months is below that.
Counting every sponsor, half of 153 studies reached it within 43 months; a quarter within 24 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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