Trial Outcomes & Findings for Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment) (NCT NCT04587752)

NCT ID: NCT04587752

Last Updated: 2024-09-23

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

post (3 months)

Results posted on

2024-09-23

Participant Flow

Participant milestones

Participant milestones
Measure
CBT for Weight Bullying
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Overall Study
STARTED
28
Overall Study
COMPLETED
21
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

data not available on two participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CBT for Weight Bullying
n=28 Participants
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Age, Categorical
<=18 years
28 Participants
n=28 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=28 Participants
Age, Categorical
>=65 years
0 Participants
n=28 Participants
Sex: Female, Male
Female
19 Participants
n=28 Participants
Sex: Female, Male
Male
9 Participants
n=28 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=28 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=28 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=28 Participants
Race (NIH/OMB)
Asian
0 Participants
n=28 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=28 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=28 Participants
Race (NIH/OMB)
White
21 Participants
n=28 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=28 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=28 Participants
Region of Enrollment
United States
28 participants
n=28 Participants
Stress
27.07 units on a scale
STANDARD_DEVIATION 14.20 • n=28 Participants
Body Dissatisfaction
3.65 units on a scale
STANDARD_DEVIATION 1.97 • n=26 Participants • data not available on two participants.
Overvaluation of Shape/Weight
3.37 units on a scale
STANDARD_DEVIATION 2.13 • n=26 Participants • data not available on two participants.

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
CBT for Weight Bullying
n=22 Participants
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Stress
20.55 units on a scale
Standard Deviation 19.07

SECONDARY outcome

Timeframe: post (3 months)

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)

Outcome measures

Outcome measures
Measure
CBT for Weight Bullying
n=20 Participants
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Body Dissatisfaction
2.85 units on a scale
Standard Deviation 2.08

SECONDARY outcome

Timeframe: post (3 months)

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)

Outcome measures

Outcome measures
Measure
CBT for Weight Bullying
n=20 Participants
Cognitive-Behavioral Therapy (CBT) for children who have experienced weight-related bullying CBT for Weight Bullying: Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
Overvaluation
1.93 units on a scale
Standard Deviation 1.83

Adverse Events

CBT for Weight Bullying

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Janet Lydecker

Yale University

Phone: 2037374299

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place