Clinical trial NCT04587752: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bullying
Weight, Body
Trauma, Psychological
Keywords: adolescent
child
cognitive behavioral therapy
eating disorder
obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will perform a clinical trial with adolescents 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 adolescents (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.

Eligibility criteria: Inclusion Criteria: To be included, adolescents must:

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

Primary outcomes:
measure: Stress
timeFrame: post (3 months)
Secondary outcomes:
measure: Body Dissatisfaction
timeFrame: post (3 months)
measure: Overvaluation
timeFrame: post (3 months)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Janet A Lydecker, PhD
role: PRINCIPAL_INVESTIGATOR
References: