Back to resultsCognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)
Primary Purpose
Bullying, Weight, Body, Trauma, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT for Weight Bullying
Sponsored by
About this trial
This is an interventional treatment trial for Bullying focused on measuring adolescent, child, cognitive behavioral therapy, eating disorder, obesity
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.
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT for Weight Bullying
Arm Description
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying
Outcomes
Primary Outcome Measures
Stress
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)
Secondary Outcome Measures
Weight concerns
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)
Shape concerns
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04587752
Brief Title
Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)
Official Title
Cognitive-Behavioral Therapy for Girls Who Experienced Weight-related Bullying (Online Telehealth Treatment Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
August 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullying, Weight, Body, Trauma, Psychological
Keywords
adolescent, child, cognitive behavioral therapy, eating disorder, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT for Weight Bullying
Arm Type
Experimental
Arm Description
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying
Intervention Type
Behavioral
Intervention Name(s)
CBT for Weight Bullying
Intervention Description
Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Primary Outcome Measure Information:
Title
Stress
Description
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)
Time Frame
post (3 months)
Secondary Outcome Measure Information:
Title
Weight concerns
Description
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)
Time Frame
post (3 months)
Title
Shape concerns
Description
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)
Time Frame
post (3 months)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identifying as female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet A Lydecker, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)
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