Clinical trial NCT05770947: Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)
Official title: Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bulimia Nervosa
Overweight or Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Eating Disorders Association
First posted: 2023-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa (binge eating and purging, or going to extremes to lose weight).

Detailed description: This study will test the feasibility and acceptability of two treatments for adolescents with higher weight seeking treatment for bulimia nervosa. Bulimia nervosa is when individuals binge eat (overeat while feeling like they lost control) and purge (do something extreme or unhealthy to lose weight or prevent weight gain). Bulimia nervosa happens across different ages and body sizes. This study is focusing on adolescents who have a larger body size. Adolescents will receive treatment that is 4 months of 45-minute sessions, weekly. Treatment will occur over telehealth (e.g., zoom), and the whole study is online.

Eligibility criteria: Inclusion Criteria:

* Have higher weight (\>85th BMI percentile or \>85th percentile in past year)
* 2 binge/purge episodes per month for the prior 3 months
* 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;
* Provide an approval form from a healthcare provider;
* Provide a signed and dated written assent (or consent for youth age 18 or 19) prior to study participation;
* Provide a signed and dated written consent from one parent prior to study participation;
* Be available for participation in the study for 4 months.

Exclusion Criteria:

* Medical or psychiatric conditions requiring hospitalization or intensive care
* anorexia nervosa
* developmental or cognitive disorders that would interfere with therapy
* pregnancy or breastfeeding
* concurrent treatments (medication or psychological) influencing appetite or weight
* began hormone therapy in prior 3 months

Primary outcomes:
measure: Change in Bulimia nervosa remission assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: baseline and post-treatment (Month 4)
Secondary outcomes:
measure: Change in Binge eating frequency assessed by the EDE-Q
timeFrame: baseline and post-treatment (Month 4)
measure: Change in Purging frequency assessed by the EDE-Q
timeFrame: baseline and post-treatment (Month 4)
measure: Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.
timeFrame: baseline and post-treatment (Month 4)
measure: Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline and post-treatment (Month 4)
measure: Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)
timeFrame: baseline and post-treatment (Month 4)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University (Teen Power - Online)
state: Connecticut
Study officials:
affiliation: Yale University
name: Janet A Lydecker, PhD
role: PRINCIPAL_INVESTIGATOR
References: