Adaptive Family Treatment for Adolescent Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.

Official Title
-----------------
Adaptive Family Treatment for Adolescent Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Intervention / Treatment
-----------------
* Behavioral: Family-Based Therapy (FBT)
* Behavioral: Family-Based Therapy with Intensive Family-Focused treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets DSM-IV criteria for anorexia nervosa Lives with at least one English-speaking parent who is willing to participate Medically Stable Adequate transportation to clinic Proficient at speaking, reading, and writing English Exclusion Criteria: Previous FBT for AN Medical condition that may affect eating or weight

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy<br>Family-Based Therapy (12 sessions) | Behavioral: Family-Based Therapy (FBT)<br>* 12 sessions of FBT over the course of 6 months.<br>|
| Experimental: Family-Based Therapy with Intensive Family-Focused Treatment<br>The patient will receive 4 sessions of Family-Based therapy, and if the participant does not make adequate weight gain within this time period, will be assigned to Intensive Family-Focused Therapy (IFT). | Behavioral: Family-Based Therapy with Intensive Family-Focused treatment<br>* FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full remission from AN (%MBW>95) | Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age) | End of Treatment (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in subscale scores of the EDE | Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores. | End of Treatment (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eating Disorder, Anorexia Nervosa, Eating Disorder Not Otherwise Specified, Maudsley, Family-Based Therapy, FBT, Family Therapy