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Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia

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ClinicalTrials.gov Identifier: NCT02054364
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
James Dale Lock, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: FBT and CRT Behavioral: FBT and art therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Study Start Date : November 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: FBT and CRT
Family-Based Treatment combined with Cognitive Remediation Therapy (15 sessions of each)
Behavioral: FBT and CRT
Other Name: Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT)

Experimental: FBT and art therapy
Family-Based Treatment combined with art therapy (15 sessions of each)
Behavioral: FBT and art therapy
Other Name: Family-Based Treatment (FBT) combined with art therapy.




Primary Outcome Measures :
  1. Full remission from AN (%MBW>95) [ Time Frame: End of Treatment (6 months) ]
    Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)



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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054364


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: James Lock, MD, PhD Stanford University

Additional Information:
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Responsible Party: James Dale Lock, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02054364     History of Changes
Other Study ID Numbers: 1R34MH101281 ( U.S. NIH Grant/Contract )
Grant Funding Number (NIH) ( Other Grant/Funding Number: SPO#109319 )
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by James Dale Lock, Stanford University:
Eating Disorder
Anorexia Nervosa
Eating Disorder Not Otherwise Specified
Maudsley
Family-Based Therapy
FBT
Family Therapy
Cognitive Remediation Therapy
CRT

Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders