Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

NCT03324724 | Completed

• 1 other identifier: 16-008708
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder; Emotional Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Eating Disorder Examination (EDE)

  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).

  baseline, end of treatment (approximately 8 months)

Study Arms (1)

Adolescents with Eating Disorder

EXPERIMENTAL

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)

Interventions

Integrative cognitive-affective therapy for adolescents (ICAT-A) BEHAVIORAL

Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.

Adolescents with Eating Disorder

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Eating Disorders Association: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jocelyn R Lebow, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., L.P.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 30, 2017
• Study Start: January 9, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)