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Cognitive Behavioral Therapy for Bulimia
N/A
Recruiting
Led By Janet A Lydecker, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-treatment (month 4)
Awards & highlights
Study Summary
This trial tests two treatments to help teens with bulimia nervosa (binge eating & purging) reduce weight healthily.
Who is the study for?
This trial is for adolescents with higher weight (above the 85th BMI percentile) who are experiencing bulimia nervosa. They must be in good general health, able to understand and write English, have healthcare provider approval, parental consent if under 18, and commit to a 4-month study period without other treatments affecting appetite or weight.Check my eligibility
What is being tested?
The study is examining the effectiveness of Cognitive Behavioral Therapy and Mindfulness as online treatments for young people with bulimia nervosa and obesity. It aims to determine how feasible and acceptable these therapies are over a four-month period.See study design
What are the potential side effects?
While not medication-based interventions, side effects may include emotional discomfort due to discussing personal issues during therapy sessions. Participants might also experience increased awareness of their eating habits which could lead to temporary distress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post-treatment (month 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-treatment (month 4)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
Secondary outcome measures
Change in Binge eating frequency assessed by the EDE-Q
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Change in Purging frequency assessed by the EDE-Q
+2 moreSide effects data
From 2021 Phase 4 trial • 12 Patients • NCT041359378%
irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
MESH
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Cognitive Behavioral Therapy for adolescents with higher weight seeking treatment for bulimia nervosa (CBT-BNh).Designed for adolescents, CBT-BNh will include psychoeducation, cognitive restructuring, and relapse prevention planning. The focus of therapy will include reducing extreme/unhealthy weight-control behaviors (purging) as well as binge eating, and self-compassion coping skills will address weight stigma and self-directed weight criticism.
Group II: MindfulnessActive Control1 Intervention
Learning to Breathe (L2B) is an existing, evidence-based program for adolescents that teaches mindfulness skills each week, including time to practice and reflect. the skills are grouped into six themes: Body, Reflections, Emotions, Attention, Tenderness, Habits, and Empowerment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Find a Location
Who is running the clinical trial?
National Eating Disorders AssociationOTHER
4 Previous Clinical Trials
319 Total Patients Enrolled
1 Trials studying Bulimia
30 Patients Enrolled for Bulimia
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,401 Total Patients Enrolled
20 Trials studying Bulimia
1,511 Patients Enrolled for Bulimia
Janet A Lydecker, PhDPrincipal InvestigatorYale University
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Bulimia
20 Patients Enrolled for Bulimia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a young person with no serious or uncontrolled health issues.I am not on treatments affecting my appetite or weight.I have not been hospitalized for medical or psychiatric reasons recently.I started hormone therapy within the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy
- Group 2: Mindfulness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor accept seniors over the age of 70?
"As the inclusion criteria stipulate, those who desire to participate in this trial must be between 12 and 19 years old. In contrast, there are 66 studies for minors aged below 18 and 234 trials for folks over 65."
Answered by AI
What is the participant quota for this experiment?
"Affirmative. According to clinicaltrials.gov, the trial is still recruiting participants; it was posted on January 24th 2023 and last updated on March 14th 2023. 40 candidates are required at a solitary research hub."
Answered by AI
Could I qualify to partake in this investigation?
"For admittance to this research, participants must have bulimia and be between 12 and 19 years of age. Currently, a total of 40 applicants will be accepted into the experiment."
Answered by AI
Are there vacancies for volunteers in this experimentation?
"The clinical trial is in full swing, having been posted on January 24th 2023 and modified most recently on March 14th. Details of the study can be found on clinicaltrials.gov."
Answered by AI
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