Anorexia NervosaNCT01579682
Adaptive Family Treatment for Adolescent Anorexia Nervosa
A study testing Family-Based Therapy (FBT) and Family-Based Therapy with Intensive Family-Focused treatment in people with Anorexia Nervosa, run by Stanford University at 2 sites in United States.
Trial summary
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. 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?
- Family-Based Therapy (FBT) and Family-Based Therapy with Intensive Family-Focused treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Meets DSM-IV criteria for anorexia nervosa
- Lives with at least one English-speaking parent who is willing to participate
- Medically Stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
Who cannot join
- Previous FBT for AN
- Medical condition that may affect eating or weight
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago
Chicago, Illinois, 60637
Stanford University
Stanford, California, 94305
About this study
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.
- Conditions
- Anorexia Nervosa
- Being tested
- Family-Based Therapy (FBT), Family-Based Therapy with Intensive Family-Focused treatment
- Keywords
- Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based Therapy (FBT)Behavioural
12 sessions of FBT over the course of 6 months.
Family-Based Therapy with Intensive Family-Focused treatmentBehavioural
FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Family-Based Therapy (12 sessions) Receives: Behavioral: Family-Based Therapy (FBT) |
| Family-Based Therapy with Intensive Family-Focused Treatment | Experimental | The patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT). Receives: Behavioral: Family-Based Therapy with Intensive Family-Focused treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full remission from AN (%MBW>95)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
Measured: End of Treatment (6 months)
Secondary outcomes (1)
Changes in subscale scores of the EDE
Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.
Measured: End of Treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, James Dale Lock, Stanford University
- Investigators
- James D Lock, MD, PhD, Principal investigator, Stanford UniversityDaniel LeGrange, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579682
- Sponsor's protocol ID
- SPO 49694
- Other IDs
- SPO 49798
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2012
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Family Treatment for Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01579682
- Acronym / sponsor ID
- SPO 49694
- Conditions
- Anorexia Nervosa
- Keywords
- Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Apr 2012 (estimated)
- 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.
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: Family-Based Therapy (FBT)Family-Based Therapy (12 sessions) |
| Family-Based Therapy with Intensive Family-Focused Treatment | Experimental | Behavioral: Family-Based Therapy with Intensive Family-Focused treatmentThe patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for anorexia nervosa
- Lives with at least one English-speaking parent who is willing to participate
- Medically Stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
Key exclusion criteria (2 listed)
- Previous FBT for AN
- Medical condition that may affect eating or weight
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 |
|---|---|---|
| Family-Based Therapy (FBT)12 sessions of FBT over the course of 6 months. | Behavioural | Psychotherapy |
| Family-Based Therapy with Intensive Family-Focused treatmentFBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame. | Behavioural | Family-Based Therapy with Intensive Family-Focused Treatment |
Primary outcome
Full remission from AN (%MBW>95)
Time frame: End of Treatment (6 months)
Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)
1 secondary outcome
Changes in subscale scores of the EDE
Time frame: End of Treatment (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Related informationLink provided by the sponsor.
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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.
James D Lock, MD, PhD principal investigator
Stanford University
Daniel LeGrange, PhD principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Based Therapy (FBT) and Family-Based Therapy with Intensive Family-Focused treatment in people with Anorexia Nervosa, run by Stanford University at 2 sites in United States.
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 5 inclusion and 2 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 13 Apr 2016. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Full remission from AN (%MBW>95) (time frame: End of Treatment (6 months)). 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 13 Apr 2016.