Anorexia NervosaPhase 3NCT00610753
Comparison of Two Types of Family Therapy in the Treatment of Adolescent Anorexia Nervosa
A Phase 3 study testing Family Behavior Therapy and Systems Family Therapy in people with Anorexia Nervosa, run by Stanford University at 7 sites in 2 countries.
Trial summary
This study will compare the effectiveness of two different family treatments 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
- Anorexia Nervosa
- What is being tested?
- Family Behavior Therapy and Systems Family Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jul 2006to Jul 2012
- Phase
- Phase 3
- 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
Inclusion Criteria:Diagnosis of anorexia nervosa with Ideal Body Weight >75% Exclusion Criteria:Current psychotic illness or mental retardation that would prohibit the use of psychotherapy Medically unstable for outpatient treatment
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Sheppard-Pratt Health System
Baltimore, Maryland, 21204
UCSD Center for Eating Disorder Treatment & Research
San Diego, California, 92037
Washington University, Department of Psychiatry
St Louis, Missouri, 63110
Stanford University School of Medicine
Stanford, California, 94305
Laureate Psychiatric Clinic & Hospital
Tulsa, Oklahoma, 74136
Department of Psychiatry, Cornell University
White Plains, New York, 10605
About this study
Official title: Family Therapy in the Treatment of Adolescent Anorexia Nervosa
This study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.
Read the detailed description
The long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy called behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Although there have been several small scale studies of BFT there has been no controlled comparison with another form of family therapy. Therefore we propose to use systems family therapy (SFT) which has been developed to represent the type of family therapy practiced in the community.
One hundred and sixty adolescents of both genders aged 12-18 years meeting DSM-IV criteria for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2 years. Participants will be randomly allocated to one of the two types of family therapy. Family therapy will be given for 36-weeks. For the purpose of the present study, patients will be followed for 12-months after the end of family treatment. Hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.
- Conditions
- Anorexia Nervosa
- Being tested
- Family Behavior Therapy, Systems Family Therapy
- Keywords
- Anorexia nervosa, Adolescents, Family therapy
- 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 Behavior TherapyBehavioural
Also called Maudsley Family Therapy
This treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues.
Systems Family TherapyBehavioural
Also called Family Therapy
This therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Family Behavioral Therapy | Experimental | This intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence. Receives: Behavioral: Family Behavior Therapy |
| Systems Family Therapy | Active comparator | This therapy focuses primarily on clarifying psychological processes within the family. Receives: Behavioral: Systems Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Ideal Body Weight (%IBW)
Patients weighed in gowns on calibrated balance beam machines and height assessed with a stadiometer. Percent Ideal Body Weight calculated on a study designed calculator.
Measured: 9-months and 21-months
Secondary outcomes (1)
Eating Disorder Psychopathology
Eating Disorders Examination obtained in a standardized interview assessing: Binge eating, purging, weight and shape concerns. Assessed as the global measure.
Measured: 9 months and 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, William Stewart Agras, Stanford University
- Investigators
- William Stewart Agras, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610753
- Sponsor's protocol ID
- SU-12132007-933
- Other IDs
- 5 U01 MH076290; SPO#33857, 5U01MH076290
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2008
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lock J, Brandt H, Woodside B, Agras S, Halmi WK, Johnson C, Kaye W, Wilfley D. Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa. Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.
PubMed 21495052Sadeh-Sharvit S, Arnow KD, Osipov L, Lock JD, Jo B, Pajarito S, Brandt H, Dodge E, Halmi KA, Johnson C, Kaye W, Wilfley D, Agras WS. Are parental self-efficacy and family flexibility mediators of treatment for anorexia nervosa? Int J Eat Disord. 2018 Mar;51(3):275-280. doi: 10.1002/eat.22826. Epub 2018 Jan 4.
PubMed 29314160Agras WS, Lock J, Brandt H, Bryson SW, Dodge E, Halmi KA, Jo B, Johnson C, Kaye W, Wilfley D, Woodside B. Comparison of 2 family therapies for adolescent anorexia nervosa: a randomized parallel trial. JAMA Psychiatry. 2014 Nov;71(11):1279-86. doi: 10.1001/jamapsychiatry.2014.1025.
PubMed 25250660
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Therapy in the Treatment of Adolescent Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00610753
- Acronym / sponsor ID
- SU-12132007-933
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Adolescents, Family therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2006
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Feb 2008 (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 two different family treatments for the treatment of adolescent anorexia nervosa.
Detailed description
The long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (AN). Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa. The focus of this study is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy called behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Although there have been several small scale studies of BFT there has been no controlled comparison with another form of family therapy. Therefore we propose to use systems family therapy (SFT) which has been developed to represent the type of family therapy practiced in the community.
One hundred and sixty adolescents of both genders aged 12-18 years meeting DSM-IV criteria for anorexia nervosa will be entered to the study. Recruitment is projected to extend for 2 years. Participants will be randomly allocated to one of the two types of family therapy. Family therapy will be given for 36-weeks. For the purpose of the present study, patients will be followed for 12-months after the end of family treatment. Hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. In a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Behavioral Therapy | Experimental | Behavioral: Family Behavior TherapyThis intervention focuses on counseling the parents (and other family members) on refeeding their child. When weight is being steadily regained the focus of therapy shifts to allow the child more independence. |
| Systems Family Therapy | Active comparator | Behavioral: Systems Family TherapyThis therapy focuses primarily on clarifying psychological processes within the family. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 Behavior TherapyAlso: Maudsley Family TherapyThis treatment is usually delivered in two phases: In the first phase there is an initial investigation of family behavior around feeding using a family meal followed by family therapy focused on enhancing feeding of the anorexic child in order to promote weight gain. In the second phase, once weight gain is well established the adolescent is given greater autonomy over feeding and in later sessions over other issues. | Behavioural | Family Behavioral Therapy |
| Systems Family TherapyAlso: Family TherapyThis therapy is applied in three phases. 1. In the first 2 or 3-sessions the treatment is explained to the family and an initial examination of family issues begins. 2. In the second phase family interactions and psychological processes are explored with clarification for family members. 3. In the third phase knowledge of family patterns is refined aiming for behavior change. | Behavioural | Systems Family Therapy |
Primary outcome
Percent Ideal Body Weight (%IBW)
Time frame: 9-months and 21-months
Patients weighed in gowns on calibrated balance beam machines and height assessed with a stadiometer. Percent Ideal Body Weight calculated on a study designed calculator.
1 secondary outcome
Eating Disorder Psychopathology
Time frame: 9 months and 21 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 11 Feb 2013.
- Background: PubMed 21495052Lock J, Brandt H, Woodside B, Agras S, Halmi WK, Johnson C, Kaye W, Wilfley D. Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa. Int J Eat Disord. 2012 Mar;45(2):202-13. doi: 10.1002/eat.20923. Epub 2011 Apr 14.
- Derived from this study: PubMed 29314160Sadeh-Sharvit S, Arnow KD, Osipov L, Lock JD, Jo B, Pajarito S, Brandt H, Dodge E, Halmi KA, Johnson C, Kaye W, Wilfley D, Agras WS. Are parental self-efficacy and family flexibility mediators of treatment for anorexia nervosa? Int J Eat Disord. 2018 Mar;51(3):275-280. doi: 10.1002/eat.22826. Epub 2018 Jan 4.
- Derived from this study: PubMed 25250660Agras WS, Lock J, Brandt H, Bryson SW, Dodge E, Halmi KA, Jo B, Johnson C, Kaye W, Wilfley D, Woodside B. Comparison of 2 family therapies for adolescent anorexia nervosa: a randomized parallel trial. JAMA Psychiatry. 2014 Nov;71(11):1279-86. doi: 10.1001/jamapsychiatry.2014.1025.
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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.
William Stewart Agras principal investigator
Stanford University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Family Behavior Therapy and Systems Family Therapy in people with Anorexia Nervosa, run by Stanford University at 7 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?
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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percent Ideal Body Weight (%IBW) (time frame: 9-months and 21-months). 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 NCT00610753, which also lists 3 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 11 Feb 2013.