Addressing Anxiety and Stress for Healthier Eating in Teens

  • STATUS
    Recruiting
  • End date
    May 16, 2024
  • participants needed
    40
  • sponsor
    The Metis Foundation
Updated on 16 September 2021
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Summary

Project ASSET will explore the preliminary efficacy of interpersonal therapy, when compared with cognitive behavioral therapy, for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety. As a pilot for a larger multi-site study, this trial will also test multi-site feasibility, acceptability, and intervention fidelity.

Description

This study is a randomized controlled trial in which 40 adolescent girls aged 12-17 years-old with weight in the 75th percentile or higher for their age and sex, and elevated anxiety symptoms, will be randomly assigned to an IPT or CBT 12-week group intervention. Approximately 20 adolescent girls will be enrolled at each of two sites: Uniformed Services University (USU) and Colorado State University (CSU). After a screening and baseline assessment, participants will attend an individual meeting with the leaders of their assigned group to learn more about the group process and establish goals. They will then participate in the group program for 12 consecutive weeks. Each group will be led by a PhD-level clinical psychologist and a healthcare trainee. In-person and remote assessments, will be conducted at baseline, in the ~two weeks post-intervention (i.e., 12-week follow-up), and at 1, 2, and 3 years post-intervention. These assessments will consist of body measurements, blood draws for collection markers of metabolic functioning, and surveys and interviews of psychological and social functioning. At baseline, two weeks, and one year post-intervention, participants will also have a week-long period during which they will wear devices collecting activity and physiological data, and complete phone surveys assessing disinhibited eating behaviors, food craving, affect, cognitions, and avoidance behaviors.

Details
Condition Anxiety Disorders, Feeding and Eating Disorders, Obesity, ANXIETY NEUROSIS, psychiatric disease, Generalized Anxiety Disorder (GAD), psychiatric illness, Mental illness, mental disorders, Anxiety Symptoms, psychiatric diseases, anxiety disorder, psychiatric disorders, adiposity, Body Weight, mental disease, Psychological Disorders, mental disorder, Anxiety, Eating Behavior, psychiatric disorder, anxious, Overweight, Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders (Pediatric), psychological disorder
Treatment Interpersonal Psychotherapy (IPT), Cognitive Behavioral Theory (CBT)
Clinical Study IdentifierNCT05038033
SponsorThe Metis Foundation
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-17-year-old adolescent girls
BMI 75th percentile
Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale

Exclusion Criteria

Any medical condition (as well as pregnancy or breastfeeding)
Individuals who have any DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study
Medication impacting mood or weight
Psychotherapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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