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Trial record 62 of 697 for:    eating disorders OR anorexia OR appetite disorder OR binge eating disorder OR bulimia OR coprophagia OR hyperphagia OR pica disease OR purge OR orthorexia OR feeding behaviors OR nutrition disorders OR obesity OR thinness OR women's health | Recruiting, Not yet recruiting, Available Studies | NIH

Adaptive Treatment for Adolescent Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT03097874
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
University of California, San Francisco
National Institutes of Health (NIH)
Information provided by (Responsible Party):
James Dale Lock, Stanford University

Brief Summary:
The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.

Condition or disease Intervention/treatment Phase
Eating Disorder Anorexia Anorexia Nervosa Anorexia in Adolescence Anorexia in Children Anorexia Nervosa Restricting Type Anorexia Nervosa, Atypical Eating Disorders in Adolescence Behavioral: Family Based Treatment Behavioral: Family Based Treatment + Intensive Parental Coaching Not Applicable

Detailed Description:

Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, and other bay-area medical programs and clinics. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively.

At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual.

At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: Family Based Treatment
Family Based Treatment of adolescent Anorexia Nervosa
Behavioral: Family Based Treatment
Family Based Treatment of adolescent Anorexia Nervosa
Other Name: Maudsley Method

Experimental: Family Based Treatment + Intensive Parental Coaching
Family Based Treatment plus Intensive Parental Coaching if weight milestones are not met by session 4.
Behavioral: Family Based Treatment + Intensive Parental Coaching
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
Other Name: FBT + IPC




Primary Outcome Measures :
  1. Estimated Body Weight (EBW) [ Time Frame: following 9 months of treatment ]
    individual with anorexia nervosa's body weight at end of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12-18 years of age and living with participants' families
  • meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement
  • medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine.

Exclusion Criteria:

  • associated physical illness that necessitates hospitalization
  • psychotic illness, mental retardation, or any other mental illnesses that would prohibit the use of psychotherapy
  • current dependence on drugs or alcohol
  • physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • previous FBT
  • currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months
  • in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment.

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): NCT03097874


Contacts
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Contact: Alex M L'Insalata, BA 6507239182 alinsalata@stanford.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Claire Trainor, BA    415-476-0622    claire.trainor@ucsf.edu   
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305-5723
Contact: Alexa M L'Insalata, BA    650-723-9182    alinsalata@stanford.edu   
Sponsors and Collaborators
Stanford University
University of California, San Francisco
National Institutes of Health (NIH)

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Responsible Party: James Dale Lock, MD, PhD, Stanford University
ClinicalTrials.gov Identifier: NCT03097874     History of Changes
Other Study ID Numbers: 1R01MH110538 ( U.S. NIH Grant/Contract )
SPO 121859 ( Other Grant/Funding Number: NIH )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Dale Lock, Stanford University:
anorexia
anorexia nervosa
eating disorder
eating
weight
weight loss
family based treatment
FBT
family treatment
therapy
Maudsley method
Additional relevant MeSH terms:
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Disease
Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms