Anorexia NervosaNCT01190423
Treatment for Young Adults With Anorexia Nervosa
A study testing Family Based Therapy for young adults in people with Anorexia Nervosa, run by Temple University at 1 site in United States.
Trial summary
Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Family Based Therapy for young adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2016
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)
- Medically stable for outpatient treatment
- Availability of at least one supportive adult of choice in study client's environment
- Stable dose of psychotropic medication (8 weeks) for co-morbid condition
Who cannot join
- Associated physical illness that necessitates hospitalization
- Psychotic illness or other mental illness requiring hospitalization
- Current dependence on drugs or alcohol
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- Previous Family-Based Treatment for Anorexia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa
Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.
Read the detailed description
Anorexia Nervosa (AN) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. The illness severely affects physical, emotional, and social functioning. The mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. Lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality.
Treatment-outcome for adult AN is poor with a quarter of adults with AN having poor outcome. In AN, promising outcomes are seen in family-based treatment (FBT) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. A manualized version of FBT has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. Despite its efficacy with adolescents, FBT has not been utilized with young adults.
The purpose of this study is to develop and refine FBT to promote weight gain in young adults with Anorexia Nervosa.
- Conditions
- Anorexia Nervosa
- Being tested
- Family Based Therapy for young adults
- Keywords
- AN
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based Therapy for young adultsBehavioural
Also called FBT, FBT-Y
Individual and Group Therapy Sessions
| Study group | Role | What they receive |
|---|---|---|
| Family Based therapy for young adults | Experimental | Not described Receives: Behavioral: Family Based Therapy for young adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (BMI)
Measured: 6 months of treatment
Secondary outcomes (1)
Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
Measured: 18 therapy sessions or 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2016
- Study completionApr 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Eunice Y Chen, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190423
- Sponsor's protocol ID
- 20550
- Other IDs
- R34MH083914-01
- Status last verified
- Apr 2018
- First submitted
- 25 Aug 2010
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen EY, Weissman JA, Zeffiro TA, Yiu A, Eneva KT, Arlt JM, Swantek MJ. Family-Based Therapy for Young Adults with Anorexia Nervosa Restores Weight. Int J Eat Disord. 2016 Jul;49(7):701-7. doi: 10.1002/eat.22513. Epub 2016 Apr 1.
PubMed 27037965
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01190423
- Acronym / sponsor ID
- 20550
- Conditions
- Anorexia Nervosa
- Keywords
- AN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Aug 2010 (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.
Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.
Detailed description
Anorexia Nervosa (AN) is a serious psychiatric illness that occurs in an estimated 0.5 to 3.7% of women. The illness severely affects physical, emotional, and social functioning. The mortality rates associated with this severely disabling condition are higher than those for any other psychiatric disorder and substantially higher than those expected in the general population. Lower weight at presentation, longer illness duration, and alcohol abuse are associated with a higher risk of mortality.
Treatment-outcome for adult AN is poor with a quarter of adults with AN having poor outcome. In AN, promising outcomes are seen in family-based treatment (FBT) for adolescent patients who present between the ages of 12 to 18 with a short duration of illness. A manualized version of FBT has now been tested in several studies and case series, showing that well over 80% of participants had good or intermediate outcome at post-treatment. Despite its efficacy with adolescents, FBT has not been utilized with young adults.
The purpose of this study is to develop and refine FBT to promote weight gain in young adults with Anorexia Nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Based therapy for young adults | Experimental | Behavioral: Family Based Therapy for young adults |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)
- Medically stable for outpatient treatment
- Availability of at least one supportive adult of choice in study client's environment
- Stable dose of psychotropic medication (8 weeks) for co-morbid condition
Key exclusion criteria (5 listed)
- Associated physical illness that necessitates hospitalization
- Psychotic illness or other mental illness requiring hospitalization
- Current dependence on drugs or alcohol
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
- Previous Family-Based Treatment for Anorexia
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 for young adultsAlso: FBT, FBT-YIndividual and Group Therapy Sessions | Behavioural | Family Based therapy for young adults |
Primary outcome
Weight (BMI)
Time frame: 6 months of treatment
1 secondary outcome
Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
Time frame: 18 therapy sessions or 6 months of treatment
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 17 Apr 2018.
- Results publication: PubMed 27037965Chen EY, Weissman JA, Zeffiro TA, Yiu A, Eneva KT, Arlt JM, Swantek MJ. Family-Based Therapy for Young Adults with Anorexia Nervosa Restores Weight. Int J Eat Disord. 2016 Jul;49(7):701-7. doi: 10.1002/eat.22513. Epub 2016 Apr 1.
- For More Information About The StudyLink provided by the sponsor.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Eunice Y Chen, PhD principal investigator
Temple University
1 site 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 for young adults in people with Anorexia Nervosa, run by Temple University at 1 site 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 4 inclusion and 5 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Weight (BMI) (time frame: 6 months of treatment). 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 NCT01190423, 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 17 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.