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Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents

Primary Purpose

Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Therapy ("Maudsley Method")
Individual Supportive Psychotherapy
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring Anorexia Nervosa

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Based Therapy

Individual Supportive Psychotherapy

Arm Description

Participants will receive family based therapy (FBT)

Participants will receive individual supportive psychotherapy (ISP)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Height
This variable informs the calculation of the outcome variable of BMI Z-score.
Weight
This variable informs the calculation of the outcome variable of BMI Z-score.
BMI
body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.
BMI Percentile
Body Mass Index (BMI) percentile. This is not a primary outcome variable.

Full Information

First Posted
January 3, 2007
Last Updated
November 19, 2015
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00418977
Brief Title
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
Official Title
Early Identification and Treatment of Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.
Detailed Description
Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa is a type of eating disorder in which a person does not eat enough for fear of becoming overweight, resulting in extreme weight loss. Women are at a greater risk of developing this disease, particularly when they are between the ages of 12 and 24. Treatments for anorexia nervosa typically include nutrition counseling, psychotherapy, and medication. The purpose of this study is to compare the effectiveness of two therapies to treat adolescents who have signs of anorexia nervosa but have not fully developed the disease. Potential participants will attend 2 screening visits during which parents and children will complete separate questionnaires and undergo 3 interviews regarding eating behaviors and changes in mood. Once screening evaluations have been completed, eligible participants will be randomly assigned to 1 of 2 treatment groups. Participants assigned to the first group will receive 14 family therapy sessions. All family members living with the child will be asked to attend these sessions with the child. Family members will learn strategies to help the child eat enough at home and will address various issues concerning family relationships. Children will learn how to eat well on their own and will also discuss topics related to family dynamics. Participants assigned to the second group will receive 14 individual therapy sessions that will focus on the child and not include family members. Before each treatment session, parents will speak with the therapist to discuss progress and any new concerns or issues regarding the child's condition. The therapist will then work directly with the child to discuss what may be causing the child's signs of anorexia nervosa and how to handle difficult emotions associated with the disorder. Participants in both treatment groups will attend 1-hour therapy sessions that will occur weekly for 8 sessions, then biweekly for 4 sessions, and monthly for the last 2 sessions. Evaluations, lasting 3 to 4 hours, will occur before treatment begins, immediately following treatment, and 6 and 12 months post-treatment. Evaluations will consist of interviews and questionnaires used to assess whether treatment was effective in preventing participants from developing anorexia nervosa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Based Therapy
Arm Type
Experimental
Arm Description
Participants will receive family based therapy (FBT)
Arm Title
Individual Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive individual supportive psychotherapy (ISP)
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Therapy ("Maudsley Method")
Other Intervention Name(s)
FBT, Maudsley Method
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual Supportive Psychotherapy
Other Intervention Name(s)
ISP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI) Z-score
Description
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Height
Description
This variable informs the calculation of the outcome variable of BMI Z-score.
Time Frame
up to 1 year
Title
Weight
Description
This variable informs the calculation of the outcome variable of BMI Z-score.
Time Frame
up to 1 year
Title
BMI
Description
body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.
Time Frame
up to 1 year
Title
BMI Percentile
Description
Body Mass Index (BMI) percentile. This is not a primary outcome variable.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Loeb, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32038326
Citation
Loeb 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.
Results Reference
derived

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Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents

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