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Clinical Trials/NCT04587752
NCT04587752
Completed
Not Applicable

Cognitive-Behavioral Therapy for Girls Who Experienced Weight-related Bullying (Online Telehealth Treatment Study)

Yale University1 site in 1 country30 target enrollmentOctober 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bullying
Sponsor
Yale University
Enrollment
30
Locations
1
Primary Endpoint
Stress
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will perform a clinical trial with adolescent girls to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.

Detailed Description

Youth with obesity are more likely to be bullied than healthy-weight peers and weight-related bullying is the most common form of bullying. Treating bullying during childhood could reduce immediate and long-term health consequences, but there are no established individual-level treatments for weight-related bullying despite recommendations that they could improve children's health. This study will develop and test a new treatment for adolescent girls (11-17 years old) who have experienced bullying due to weight. The treatment will address traumatic stress and potentially co-occurring or developing problems with unhealthy weight-control behaviors, disordered eating, and weight. The treatment will be conducted via audio/video telehealth to increase accessibility and is therefore available to anyone in the United States who meets eligibility criteria.

Registry
clinicaltrials.gov
Start Date
October 5, 2020
End Date
August 9, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • To be included, adolescents must:
  • Be in the age range ≥11 years old and ≤17 years old;
  • Identify as female
  • Report experiencing weight-related bullying
  • Report current distress about weight-related bullying
  • Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials;
  • Located in the United States and available for participation in the study for 3 months.

Exclusion Criteria

  • Prospective participants will be excluded if the adolescent:
  • Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., severe anorexia, neurological disorder, psychotic disorders, suicidality);
  • Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
  • Is pregnant or breastfeeding;
  • Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
  • Is engaged in concurrent treatments that focus on trauma-related stress;
  • Began taking hormonal contraceptives less than 3 months prior;
  • Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
  • Has avoidant/restrictive food intake disorder; or
  • Is participating in another clinical research study.

Outcomes

Primary Outcomes

Stress

Time Frame: post (3 months)

Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (total; scores range from 0 to 65 with higher scores indicative of more traumatic stress)

Secondary Outcomes

  • Body Dissatisfaction(post (3 months))
  • Overvaluation(post (3 months))

Study Sites (1)

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