Anorexia NervosaNCT04957498
Feasibility Study Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
A study testing Guided Self-Help for Family Based Treatment and Family Based Treatment in people with Anorexia Nervosa, run by Stanford University at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Guided Self-Help for Family Based Treatment and Family Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Aug 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Guided Self-Help for Family Based Treatment, Family Based Treatment
- Keywords
- FBT, Family Based Treatment, Guided Self-Help
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Help for Family Based TreatmentBehavioural
Also called FBT-GSH
A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
Family Based TreatmentBehavioural
Also called FBT
Standard Family Based Treatment provided for up to 15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| FBT | Active comparator | Family Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. Receives: Behavioral: Family Based Treatment |
| FBT-GSH | Experimental | 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. Receives: Behavioral: Guided Self-Help for Family Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled in the study per month.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through end of treatment (up to approximately 6 months)
Serious Adverse Events
Number of events in which a participant required hospitalization
Measured: Baseline through end of treatment period (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Aug 2019
- Primary completion18 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957498
- Sponsor's protocol ID
- 43195
- Status last verified
- May 2022
- First submitted
- 29 Jun 2021
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Conducting a Randomized Controlled Trial Comparing Standard FBT and Guided Self-Help FBT for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04957498
- Acronym / sponsor ID
- 43195
- Conditions
- Anorexia Nervosa
- Keywords
- FBT, Family Based Treatment, Guided Self-Help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 13 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT | Active comparator | Behavioral: Family Based TreatmentFamily Based Treatment (FBT) includes up to 15 session (50-60 minutes) with a trained therapist. |
| FBT-GSH | Experimental | Behavioral: Guided Self-Help for Family Based TreatmentFamily 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Help for Family Based TreatmentAlso: FBT-GSHA online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist. | Behavioural | FBT-GSH |
| Family Based TreatmentAlso: FBTStandard Family Based Treatment provided for up to 15 sessions. | Behavioural | FBT |
Primary outcome
Recruitment Rate
Time frame: Assessed through the end of recruitment (about one year)
Number of participants enrolled in the study per month.
Treatment Retention Rate
Time frame: Up to 6 months
The count of participants who did not stop treatment before finishing their randomized treatment course (FBT-V or GSH-FBT).
Study Retention Rate
Time frame: Up to 9 months
The number of participants who provided information for the end of treatment assessment and 3-month follow up assessment.
Treatment Acceptability Ratings
Time frame: 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.
Treatment Acceptability Ratings
Time frame: 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.
Number of Treatment Sessions Attended
Time frame: 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.
Serious Adverse Events
Time frame: Baseline through end of treatment period (up to 6 months)
Number of events in which a participant required hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help for Family Based Treatment and Family Based Treatment in people with Anorexia Nervosa, run by Stanford University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Assessed through the end of recruitment (about one year)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.