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

Early Identification and Treatment of Anorexia Nervosa

This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Behavioral: Family-Based Therapy ("Maudsley Method"); Behavioral: Individual Supportive Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Based Therapy; Participants will receive family based therapy (FBT)	Behavioral: Family-Based Therapy ("Maudsley Method"); 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.; Other Names: FBT; Maudsley Method
Active Comparator: Individual Supportive Psychotherapy; Participants will receive individual supportive psychotherapy (ISP)	Behavioral: Individual Supportive Psychotherapy; 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.; Other Names: ISP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	This variable informs the calculation of the outcome variable of BMI Z-score.	up to 1 year
Weight	This variable informs the calculation of the outcome variable of BMI Z-score.	up to 1 year
BMI	body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.	up to 1 year
BMI Percentile	Body Mass Index (BMI) percentile. This is not a primary outcome variable.	up to 1 year

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Katharine Loeb, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: January 3, 2007
• First Submitted That Met QC Criteria: January 3, 2007
• First Posted (Estimate): January 5, 2007

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Anorexia Nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders
• Other Study ID Numbers: GCO 04-0978; DSIR 84-CTS (Division of Services and Intervention Research); K23MH074506 (U.S. NIH Grant/Contract)