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Trial record 4 of 1222 for:    eating disorders

Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)

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ClinicalTrials.gov Identifier: NCT03324724
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
National Eating Disorder Association
Information provided by (Responsible Party):
Jocelyn R. Lebow, Mayo Clinic

Brief Summary:
Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.

Condition or disease Intervention/treatment Phase
Eating Disorder Emotional Disorder Behavioral: Integrative cognitive-affective therapy for adolescents (ICAT-A) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : January 3, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Adolescents with Eating Disorder
Adolescents with bulimia nervosa or binge eating disorder, with one or more of their parents, will receive integrative cognitive-affective therapy for adolescents (ICAT-A).
Behavioral: Integrative cognitive-affective therapy for adolescents (ICAT-A)
Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.




Primary Outcome Measures :
  1. Change in Eating Disorder Examination (EDE) [ Time Frame: baseline, end of treatment (approximately 8 months) ]
    The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales and a global score. The four subscales are: 1) Restraint, 2) Eating concern, 3) Shape concern, 4) Weight concern. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period, but some questions extend out to cover the previous 3 months. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall score, the four subscales scores are summed and the resulting total divided by the number of subscales (4). The total score can range from 0 (normal) to 6 (high eating disorder).



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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
  • No major weight loss (defined as a reduction of 10% baseline body weight or more)
  • Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
  • Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
  • Subject must be living at home
  • At least one parent/guardian is willing to participate in the treatment.

Exclusion Criteria:

  • Subject on medications that influence weight or appetite (including antipsychotic medications)
  • Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
  • Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
  • Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate 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): NCT03324724


Contacts
Contact: Barbara A Hall 507-266-5374 all.barbara2@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Barbara A Hall    507-266-5374    hall.barbara2@mayo.edu   
Principal Investigator: Jocelyn R Lebow, PhD         
Sponsors and Collaborators
Mayo Clinic
National Eating Disorder Association
Investigators
Principal Investigator: Jocelyn R Lebow, PhD Mayo Clinic

Responsible Party: Jocelyn R. Lebow, Ph.D., L.P., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03324724     History of Changes
Other Study ID Numbers: 16-008708
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders