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

Early Identification and Treatment of Anorexia Nervosa

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00418977

Enrollment

Registered

2007-01-05

Start date

2005-09-30

Completion date

2011-08-31

Last updated

2015-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders

Keywords

Anorexia Nervosa

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.

Interventions

BEHAVIORALFamily-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.

BEHAVIORALIndividual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Body Mass Index (BMI) Z-score	up to 1 year	Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator

Secondary

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

Countries

United States

Participant flow

Recruitment details

Recruitment period Oct 2007 to Feb 2011 primarily via physicians and other clinicians/centers evaluating or treating children and adolescents with eating disorder symptoms.

Participants by arm

Arm	Count
Family Based Therapy Participants received family based therapy (FBT)	43
Individual Supportive Psychotherapy Participants received individual supportive psychotherapy (ISP)	16
Total	59

Baseline characteristics

Characteristic	Family Based Therapy	Individual Supportive Psychotherapy	Total
Age, Continuous	13.3 years STANDARD_DEVIATION 2	14.8 years STANDARD_DEVIATION 2	13.7 years STANDARD_DEVIATION 2.1
Sex: Female, Male Female	37 Participants	13 Participants	50 Participants
Sex: Female, Male Male	6 Participants	3 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 43	0 / 16
serious Total, serious adverse events	0 / 43	0 / 16

Arm	Measure	Value (MEAN)	Dispersion
Family Based Therapy	Weight	94.9 pounds	Standard Deviation 21
Individual Supportive Psychotherapy	Weight	114.7 pounds	Standard Deviation 29.1

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026