Adaptive Family Treatment for Adolescent Anorexia Nervosa

NCT ID: NCT01579682

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psychotherapy

Family-Based Therapy (12 sessions)

Group Type EXPERIMENTAL

Family-Based Therapy (FBT)

Intervention Type BEHAVIORAL

12 sessions of FBT over the course of 6 months.

Family-Based Therapy with Intensive Family-Focused Treatment

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).

Group Type EXPERIMENTAL

Family-Based Therapy with Intensive Family-Focused treatment

Intervention Type BEHAVIORAL

FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.

Interventions

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Family-Based Therapy (FBT)

12 sessions of FBT over the course of 6 months.

Intervention Type BEHAVIORAL

Family-Based Therapy with Intensive Family-Focused treatment

FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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James Dale Lock

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James D Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Daniel LeGrange, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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Stanford University

Stanford, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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SPO 49798

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPO 49694

Identifier Type: -

Identifier Source: org_study_id

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