Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
Early Identification and Treatment of Anorexia Nervosa
3 other identifiers
interventional
59
1 country
1
Brief Summary
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 3, 2007
CompletedFirst Posted
Study publicly available on registry
January 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
April 28, 2014
CompletedDecember 23, 2015
November 1, 2015
5.9 years
January 3, 2007
March 10, 2014
November 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Mass Index (BMI) Z-score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
up to 1 year
Secondary Outcomes (4)
Height
up to 1 year
Weight
up to 1 year
BMI
up to 1 year
BMI Percentile
up to 1 year
Study Arms (2)
Family Based Therapy
EXPERIMENTALParticipants will receive family based therapy (FBT)
Individual Supportive Psychotherapy
ACTIVE COMPARATORParticipants will receive individual supportive psychotherapy (ISP)
Interventions
The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction.
The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment.
Eligibility Criteria
You may qualify if:
- Living with family or guardian
- Medically stable for outpatient treatment
- Meets two to three criteria for anorexia nervosa
- Receiving a stable dose of psychotropic medication (if applicable)
You may not qualify if:
- Meets DSM-IV criteria for anorexia nervosa
- Current psychotic illness, alcohol or drug dependence, or medical or physical conditions known to influence eating, weight, or menstrual status
- Previous participation in study treatment
- Unable to withdraw from current psychological treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (2)
Drury CR, Hail L, Rienecke RD, Accurso EC, Coelho JS, Lock J, Le Grange D, Loeb KL. Psychometric properties of the Parent Eating Disorder Examination Questionnaire. Int J Eat Disord. 2023 Sep;56(9):1730-1742. doi: 10.1002/eat.23999. Epub 2023 May 29.
PMID: 37248808DERIVEDLoeb KL, Weissman RS, Marcus S, Pattanayak C, Hail L, Kung KC, Schron D, Zucker N, Le Grange D, Lock J, Newcorn JH, Taylor CB, Walsh BT. Family-Based Treatment for Anorexia Nervosa Symptoms in High-Risk Youth: A Partially-Randomized Preference-Design Study. Front Psychiatry. 2020 Jan 22;10:985. doi: 10.3389/fpsyt.2019.00985. eCollection 2019.
PMID: 32038326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations include a small sample size and attrition leading to missing end-of-intervention data. In addition, participation with follow-up evaluations was poor.
Results Point of Contact
- Title
- Katharine Loeb, PhD
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- PRINCIPAL INVESTIGATOR
Katharine Loeb, PhD
Icahn School of Medicine at Mount Sinai
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2007
First Posted
January 5, 2007
Study Start
September 1, 2005
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 23, 2015
Results First Posted
April 28, 2014
Record last verified: 2015-11