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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

No Placebo-Only Group

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.

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-treatment (month 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)

Secondary study objectives

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 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out