Anorexia NervosaNCT05563649
Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
A study testing Online Guided Self-Help-Family-based Treatment and FBT via Videoconferencing in people with Anorexia Nervosa, run by Stanford University at 2 sites in 2 countries.
Trial summary
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. 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?
- Online Guided Self-Help-Family-based Treatment and FBT via Videoconferencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Mar 2023to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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)
- EBW above 75%
- 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
- Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Ainsley E Cogburn, B.S., 6507239182, familytreatment@stanford.edu
James D Lock, MD, PhD
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario
Sadaf Sami, MD, CCRA, samis2@mcmaster.ca
About this study
Official title: Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
- Conditions
- Anorexia Nervosa
- Being tested
- Online Guided Self-Help-Family-based Treatment, FBT via Videoconferencing
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Guided Self-Help-Family-based TreatmentBehavioural
Also called GSH-FBT
GSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an introduction orienting the viewer to the videos, 5-9 short videos (< 7 minutes each), and assigned reading from the parent education manual Help Your Teenager Beat an Eating Disorder. Three lectures include additional resources for parents (e.g., Academy of Eating Disorder (AED) Medical Management Guidelines). Homework assignments are included with some lectures (e.g., strategies to help the child eat during meals, practice making calorically dense meals). In line with GSH approaches, coach-therapists direct parents, to watch or re-watch specific video content contained in the online learning material related to their questions rather than direct behavioral change.
FBT via VideoconferencingBehavioural
Also called FBT-V
15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family.
| Study group | Role | What they receive |
|---|---|---|
| Online Guided Self-Help-Family-based Treatment (GSH-FBT) | Experimental | GSH-FBT consists of 10 20-minute parent-only sessions over 9 months. The guidance portion is manualized and will be delivered by a clinician familiar with both the online modules and FBT, who acts as a "coach." Sessions follow an online curriculum containing a total of 65 short videos. Each lecture series is comprised of a written introduction orienting the viewer to the videos, 5-9 short videos (< 7 minutes each), and assigned reading from the parent education manual, Help Your Teenager Beat an Eating Disorder. In line with GSH approaches, coaches direct parents to watch or re-watch specific videos contained in the online platform related to their questions. Receives: Behavioral: Online Guided Self-Help-Family-based Treatment |
| FBT via Videoconferencing (FBT-V) | Active comparator | 15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family. Receives: Behavioral: FBT via Videoconferencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of therapist hours to %EBW change
The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.
Measured: Assessed from baseline through end of treatment (EOT)
Secondary outcomes (3)
Eating Disorder Examination (EDE)
The EDE is a standardized investigator-based interview that measures the severity of the characteristic psychopathology of eating disorders. The psychometric properties of the EDE are sound and validated in diverse samples. It takes about 1 hour to complete.
Measured: Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up
Beck Depression Inventory (BDI)
The BDI is a measure with sound psychometric properties and was validated on a diverse sample. It has been used in numerous studies of adolescent depression. This measure also includes questions about suicidal ideation and intent and will be used to assess suicide during the study. These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points. It takes about 10 minutes to complete.
Measured: These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up)
Beck Anxiety Inventory (BAI)
The BAI is a 21-item questionnaire about anxiety that has sound psychometric properties and was validated on a diverse sample. Assessments will be collected at baseline, sessions 2, 4, 6, 8, and EOT.
Measured: Baseline, sessions 2, 4, 6, 8, and EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start17 Mar 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563649
- Sponsor's protocol ID
- 67295
- Other IDs
- R01MH130388
- Status last verified
- May 2025
- First submitted
- 28 Sep 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurcan H, Couturier J, Matheson B, Jo B, Lock J. Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa. Contemp Clin Trials. 2024 Sep;144:107618. doi: 10.1016/j.cct.2024.107618. Epub 2024 Jul 4.
PubMed 38971303
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirming the Effectiveness and Efficiency of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05563649
- Acronym / sponsor ID
- 67295
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Guided Self-Help-Family-based Treatment (GSH-FBT) | Experimental | Behavioral: Online Guided Self-Help-Family-based TreatmentGSH-FBT consists of 10 20-minute parent-only sessions over 9 months. The guidance portion is manualized and will be delivered by a clinician familiar with both the online modules and FBT, who acts as a "coach." Sessions follow an online curriculum containing a total of 65 short videos. Each lecture series is comprised of a written introduction orienting the viewer to the videos, 5-9 short videos (< 7 minutes each), and assigned reading from the parent education manual, Help Your Teenager Beat an Eating Disorder. In line with GSH approaches, coaches direct parents to watch or re-watch specific videos contained in the online platform related to their questions. |
| FBT via Videoconferencing (FBT-V) | Active comparator | Behavioral: FBT via Videoconferencing15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family. |
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)
- EBW above 75%
Key exclusion criteria (1 listed)
- Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
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 |
|---|---|---|
| Online Guided Self-Help-Family-based TreatmentAlso: GSH-FBTGSH-FBT consists of 10 20-minute sessions for parents only over 9 months. Sessions follow an online curriculum of 65 short videos: 62 with an expert clinician instructing parents on the principles of FBT, and 3 reflections from an adolescent who recovered from AN and completed FBT. Each lecture series contains an introduction orienting the viewer to the videos, 5-9 short videos (< 7 minutes each), and assigned reading from the parent education manual Help Your Teenager Beat an Eating Disorder. Three lectures include additional resources for parents (e.g., Academy of Eating Disorder (AED) Medical Management Guidelines). Homework assignments are included with some lectures (e.g., strategies to help the child eat during meals, practice making calorically dense meals). In line with GSH approaches, coach-therapists direct parents, to watch or re-watch specific video content contained in the online learning material related to their questions rather than direct behavioral change. | Behavioural | Online Guided Self-Help-Family-based Treatment (GSH-FBT) |
| FBT via VideoconferencingAlso: FBT-V15 60-minute sessions of 3-phase manualized FBT modified for videoconferencing will be delivered to participants randomized to this treatment by therapists trained in FBT. The first phase encourages parental management of weight restoration (approximately 8 weekly sessions); the second phase promotes a developmentally appropriate transition back to adolescent management of weight restoration and maintenance under parental supervision (approximately 4 bi-weekly sessions), and the third phase focuses on adolescent development (approximately 3 monthly sessions). Each session consists of 10 minutes with the adolescent individually to discuss progress and the adolescent's perspective on treatment, followed by 50 minutes with the entire family. | Behavioural | FBT via Videoconferencing (FBT-V) |
Primary outcome
Ratio of therapist hours to %EBW change
Time frame: Assessed from baseline through end of treatment (EOT)
The investigators will compare GSH-FBT and FBT-V groups at EOT in terms of the change in %EBW from baseline divided by total therapist time utilized. Estimated Body Weight (EBW) percentages used will be calculated using Center for Disease Control metrics in children and adolescents. Total therapist time utilized will be collected based on video records of actual sessions spent with participants.
3 secondary outcomes
Eating Disorder Examination (EDE)
Time frame: Baseline (before beginning treatment); 3 months within treatment; 9 months (EOT); and at 6- and 12-month follow-up
Beck Depression Inventory (BDI)
Time frame: These assessments will be collected bi-weekly (sessions 2, 4, 6, 8) and at all major assessment points (BL, 3 months within treatment, EOT, 6 and 12-month follow-up)
Beck Anxiety Inventory (BAI)
Time frame: Baseline, sessions 2, 4, 6, 8, and EOT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 38971303Gurcan H, Couturier J, Matheson B, Jo B, Lock J. Protocol for a randomized clinical trial to confirm the effectiveness of online guided self-help family-based treatment for adolescent anorexia nervosa. Contemp Clin Trials. 2024 Sep;144:107618. doi: 10.1016/j.cct.2024.107618. Epub 2024 Jul 4.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Guided Self-Help-Family-based Treatment and FBT via Videoconferencing 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 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ainsley E Cogburn, B.S. (6507239182, familytreatment@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of therapist hours to %EBW change (time frame: Assessed from baseline through end of treatment (EOT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563649, which also lists 1 linked publication.
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 26 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.