Eating DisordersPhase 1NCT00149786
Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa
A Phase 1 study testing Family Based Therapy and Ego-Oriented Individual Psychotherapy in people with Eating Disorders, run by Stanford University at 1 site in United States.
Trial summary
This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Family Based Therapy and Ego-Oriented Individual Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Mar 2009
- Phase
- Phase 1
- 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 parent who is willing to participate
- Medically stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
Who cannot join
- Currently undergoing treatment or taking medication that may affect eating or weight
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago, Pritzker School of Medicine
Chicago, Illinois, 60637
About this study
Official title: Treatment of Adolescents With Anorexia Nervosa
This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.
Read the detailed description
In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare the effectiveness of family-based therapy versus ego-oriented individual psychotherapy for the treatment of adolescent anorexia nervosa. Simultaneously, it will examine potential predictors, mediators, and moderators of weight gain, psychological concerns about weight and shape, and changes in family functioning.
Participants in this open-label study will be randomly assigned to receive one of two types of therapy: family-based therapy or ego-oriented individual psychotherapy. Both types of therapy will be given for a total of 24 hours over the course of 12 months. Physical and psychological assessments will be completed during study visits at baseline, immediately post-treatment, six months post-treatment, and one year post-treatment. Amount of weight gain will be evaluated, along with changes in weight and body shape concerns, as measured by the Eating Disorder Examination.
- Conditions
- Eating Disorders
- Being tested
- Family Based Therapy, Ego-Oriented Individual Psychotherapy
- Keywords
- Anorexia Nervosa, Adolescents, Family therapy, Individual therapy
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based TherapyBehavioural
Also called FBT
Family therapy will be given for a total of 24 hours over the course of 12 months.
Ego-Oriented Individual PsychotherapyBehavioural
Also called EOIP
Individual therapy will be given for a total of 24 hours over the course of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Those adolescents receiving family based therapy Receives: Behavioral: Family Based Therapy |
| 2 | Active comparator | Those adolescents receiving individual therapy Receives: Behavioral: Ego-Oriented Individual Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the Eating Disorders Examination
Measured: Measured at Year 1 of treatment and Year 1 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMar 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- James D. Lock, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149786
- Sponsor's protocol ID
- R01MH070621
- Other IDs
- R01MH070621, DDTR B4-ARE
- Status last verified
- Apr 2012
- First submitted
- 6 Sep 2005
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Le Grange D, Lock J, Accurso EC, Agras WS, Darcy A, Forsberg S, Bryson SW. Relapse from remission at two- to four-year follow-up in two treatments for adolescent anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2014 Nov;53(11):1162-7. doi: 10.1016/j.jaac.2014.07.014. Epub 2014 Aug 23.
PubMed 25440306Lock J, Le Grange D, Agras WS, Moye A, Bryson SW, Jo B. Randomized clinical trial comparing family-based treatment with adolescent-focused individual therapy for adolescents with anorexia nervosa. Arch Gen Psychiatry. 2010 Oct;67(10):1025-32. doi: 10.1001/archgenpsychiatry.2010.128.
PubMed 20921118
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adolescents With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00149786
- Acronym / sponsor ID
- R01MH070621
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa, Adolescents, Family therapy, Individual therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Sep 2005 (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.
This study will compare the effectiveness of family-based therapy versus individual psychotherapy for the treatment of adolescent anorexia nervosa.
Detailed description
In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare the effectiveness of family-based therapy versus ego-oriented individual psychotherapy for the treatment of adolescent anorexia nervosa. Simultaneously, it will examine potential predictors, mediators, and moderators of weight gain, psychological concerns about weight and shape, and changes in family functioning.
Participants in this open-label study will be randomly assigned to receive one of two types of therapy: family-based therapy or ego-oriented individual psychotherapy. Both types of therapy will be given for a total of 24 hours over the course of 12 months. Physical and psychological assessments will be completed during study visits at baseline, immediately post-treatment, six months post-treatment, and one year post-treatment. Amount of weight gain will be evaluated, along with changes in weight and body shape concerns, as measured by the Eating Disorder Examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Family Based TherapyThose adolescents receiving family based therapy |
| 2 | Active comparator | Behavioral: Ego-Oriented Individual PsychotherapyThose adolescents receiving individual therapy |
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 parent who is willing to participate
- Medically stable
- Adequate transportation to clinic
- Proficient at speaking, reading, and writing English
Key exclusion criteria (1 listed)
- Currently undergoing treatment or taking medication 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 TherapyAlso: FBTFamily therapy will be given for a total of 24 hours over the course of 12 months. | Behavioural | 1 |
| Ego-Oriented Individual PsychotherapyAlso: EOIPIndividual therapy will be given for a total of 24 hours over the course of 12 months. | Behavioural | 2 |
Primary outcome
Scores on the Eating Disorders Examination
Time frame: Measured at Year 1 of treatment and Year 1 of follow-up
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 10 Apr 2012.
- Derived from this study: PubMed 25440306Le Grange D, Lock J, Accurso EC, Agras WS, Darcy A, Forsberg S, Bryson SW. Relapse from remission at two- to four-year follow-up in two treatments for adolescent anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2014 Nov;53(11):1162-7. doi: 10.1016/j.jaac.2014.07.014. Epub 2014 Aug 23.
- Derived from this study: PubMed 20921118Lock J, Le Grange D, Agras WS, Moye A, Bryson SW, Jo B. Randomized clinical trial comparing family-based treatment with adolescent-focused individual therapy for adolescents with anorexia nervosa. Arch Gen Psychiatry. 2010 Oct;67(10):1025-32. doi: 10.1001/archgenpsychiatry.2010.128.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Family Based Therapy and Ego-Oriented Individual Psychotherapy in people with Eating Disorders, run by Stanford 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 5 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: finished, as of the sponsor's last update on 10 Apr 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Scores on the Eating Disorders Examination (time frame: Measured at Year 1 of treatment and Year 1 of follow-up). 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 NCT00149786, which also lists 2 linked publications.
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 10 Apr 2012.