Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

NCT ID: NCT02054364

Last Updated: 2017-04-28

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-11-30

Brief Summary

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This study aims to investigate the feasibility of combining Cognitive Remediation Therapy (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be randomly assigned to one of two groups: one group will receive FBT and CRT, and the other group will receive FBT and art therapy.

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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FBT and CRT

Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)

Group Type EXPERIMENTAL

FBT and CRT

Intervention Type BEHAVIORAL

FBT and art therapy

Family-Based Treatment combined with art therapy (15 sessions of each)

Group Type EXPERIMENTAL

FBT and art therapy

Intervention Type BEHAVIORAL

Interventions

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FBT and CRT

Intervention Type BEHAVIORAL

FBT and art therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT) Family-Based Treatment (FBT) combined with art therapy.

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 Endorses obsessions/compulsions Adequate transportation to clinic Proficient at speaking, reading, and writing English

Exclusion Criteria

* Previous FBT or CRT for AN Medical Instability Medical condition that may affect eating or weight
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

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 Lock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Grant Funding Number (NIH)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1R34MH101281

Identifier Type: NIH

Identifier Source: org_study_id

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