Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)

September 11, 2023 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: To be included, adolescents must:

  1. Be in the age range ≥11 years old and ≤17 years old;
  2. Identify as female
  3. Report experiencing weight-related bullying
  4. Report current distress about weight-related bullying
  5. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
  6. Read, comprehend, and write English at a sufficient level to complete study-related materials;
  7. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for Weight Bullying
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying
Behavioral: CBT for Weight Bullying
Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: post (3 months)
Reductions in traumatic stress as measured by the Children's Revised Impact of Event Scale (scores range from 0 to 65 with higher scores indicative of more traumatic stress)
post (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight concerns
Time Frame: post (3 months)
Reductions in weight concerns as measured by the Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
post (3 months)
Shape concerns
Time Frame: post (3 months)
Reductions in shape concerns as measured by the Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
post (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Janet A Lydecker, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

August 9, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000028551

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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