BullyingNCT04587752
Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)
A study testing CBT for Weight Bullying in people with Bullying and Weight, Body, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years, women only
- Conditions the study is for
- Bullying, Weight, Body, Trauma, Psychological
- What is being tested?
- CBT for Weight Bullying
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Be in the age range ≥11 years old and ≤17 years old;
- 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.
Show all 16Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: Cognitive-Behavioral Therapy for Girls Who Experienced Weight-related Bullying (Online Telehealth Treatment Study)
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.
Read the 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.
- Conditions
- Bullying, Weight, Body, Trauma, Psychological
- Being tested
- CBT for Weight Bullying
- Keywords
- adolescent, child, cognitive behavioral therapy, eating disorder, obesity
- Medical subject headings
- Bullying, Body Weight, Psychological Trauma, Feeding and Eating Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Weight BullyingBehavioural
Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
| Study group | Role | What they receive |
|---|---|---|
| CBT for Weight Bullying | Experimental | Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying Receives: Behavioral: CBT for Weight Bullying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
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)
Measured: post (3 months)
Secondary outcomes (2)
Body Dissatisfaction
Reductions in body dissatisfaction (weight and shape dissatisfaction) as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
Measured: post (3 months)
Overvaluation
Reductions in overvaluation of shape/weight as measured by the brief Eating Disorder Examination Questionnaire (scores range from 0 to 6; higher scores are indicative of more concern)
Measured: post (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start5 Oct 2020
- Primary completion9 Aug 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BullyingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet A Lydecker, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587752
- Sponsor's protocol ID
- 2000028551
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2020
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lydecker JA, Ozbardakci EV, Lou R, Grilo CM. Trauma-Focused Cognitive-Behavioral Therapy for Adolescents Bullied Because of Weight: A Feasibility Study. Int J Eat Disord. 2024 Oct;57(10):2117-2127. doi: 10.1002/eat.24257. Epub 2024 Jul 15.
PubMed 39007703
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy for Girls Who Experienced Weight-related Bullying (Online Telehealth Treatment Study)
- ClinicalTrials.gov ID
- NCT04587752
- Acronym / sponsor ID
- 2000028551
- Conditions
- Bullying, Weight, Body, Trauma, Psychological
- Keywords
- adolescent, child, cognitive behavioral therapy, eating disorder, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT for Weight Bullying | Experimental | Behavioral: CBT for Weight BullyingCognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Be in the age range ≥11 years old and ≤17 years old;
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for Weight BullyingCognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth. | Behavioural | CBT for Weight Bullying |
Primary outcome
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)
2 secondary outcomes
Body Dissatisfaction
Time frame: post (3 months)
Overvaluation
Time frame: post (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39007703Lydecker JA, Ozbardakci EV, Lou R, Grilo CM. Trauma-Focused Cognitive-Behavioral Therapy for Adolescents Bullied Because of Weight: A Feasibility Study. Int J Eat Disord. 2024 Oct;57(10):2117-2127. doi: 10.1002/eat.24257. Epub 2024 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet A Lydecker, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Weight Bullying in people with Bullying and Weight, Body, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: post (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.