Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

NCT ID: NCT03324724

Last Updated: 2022-06-06

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Eating Disorder Emotional Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eating Disorders Association

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jocelyn R. Lebow

Ph.D., L.P.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jocelyn R Lebow, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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16-008708

Identifier Type: -

Identifier Source: org_study_id

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