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

Trauma, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587752
• Other study ID #: 2000028551
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: August 9, 2023

Study information

• Verified date: September 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 9, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Bullying
• Psychological Trauma
• Trauma, Psychological
• Weight, Body

Intervention

Behavioral:
• CBT for Weight Bullying
Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	post (3 months)
Secondary	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)	post (3 months)
Secondary	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)	post (3 months)