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Completed

NCT Number: NCT03324724

Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

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.

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Key information

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Eating Disorders Association

Registry information

Official study title

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

Acronym: ICAT-A

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2017
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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