Cognitive Behavioral Therapy for Adolescents With Bulimia Nervosa and Higher Weight (Online Treatment Study)

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

Mindfulness

About this trial

This is an interventional treatment trial for Bulimia Nervosa

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University (Teen Power - Online)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

Mindfulness

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Remission from binge eating and purging behaviors will be assessed by EDE-Q. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder behaviors.

Secondary Outcome Measures

Change in Binge eating frequency assessed by the EDE-Q

Number of episodes of binge eating in past month

Change in Purging frequency assessed by the EDE-Q

Number of episodes of purging in past month

Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.

Eating disorder psychopathology will be assessed using the EDE-Q global score. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder psychopathology.

Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

Depression will be assessed using the PHQ-9. PHQ-9 is a validated questionnaire used to screen for depression with a range of scores from 0-27. Higher scores indicate more severe depressive symptoms.

Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)

Self-esteem will be assessed using the RSES. The RSES is a self-report measure that consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree. The total score ranges from 0 to 30 with higher scores indicating higher self esteem.

Full Information

NCT ID

NCT05770947

First Posted

March 3, 2023

Last Updated

March 14, 2023

Sponsor

Yale University

Collaborators

National Eating Disorders Association

1. Study Identification

Unique Protocol Identification Number

NCT05770947

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 24, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Eating Disorders Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bulimia Nervosa, Overweight or Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Mindfulness

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

Cognitive Behavioral Therapy (CBT) is a psychological treatment or "talk therapy" that integrates how people think, feel, and behave to create new behavior patterns that improve thinking processes and reduce distress.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness

Other Intervention Name(s)

Learning to Breathe

Intervention Description

Mindfulness is a psychological treatment or "talk therapy" that practices different coping skills to improve thinking processes and reduce distress.

Primary Outcome Measure Information:

Title

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

Description

Remission from binge eating and purging behaviors will be assessed by EDE-Q. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder behaviors.

Time Frame

baseline and post-treatment (Month 4)

Secondary Outcome Measure Information:

Title

Change in Binge eating frequency assessed by the EDE-Q

Description

Number of episodes of binge eating in past month

Time Frame

baseline and post-treatment (Month 4)

Title

Change in Purging frequency assessed by the EDE-Q

Description

Number of episodes of purging in past month

Time Frame

baseline and post-treatment (Month 4)

Title

Change in eating disorder psychopathology assessed by the Eating Disorder Examination Questionnaire (EDE-Q) global score.

Description

Eating disorder psychopathology will be assessed using the EDE-Q global score. The EDE-Q is a self-report questionnaire with four subscales and a global severity score. the global score ranges from 0-6 with higher scores reflecting greater severity of eating disorder psychopathology.

Time Frame

baseline and post-treatment (Month 4)

Title

Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)

Description

Depression will be assessed using the PHQ-9. PHQ-9 is a validated questionnaire used to screen for depression with a range of scores from 0-27. Higher scores indicate more severe depressive symptoms.

Time Frame

baseline and post-treatment (Month 4)

Title

Change in Self-esteem assessed using the Rosenberg Self-Esteem Scale (RSES)

Description

Self-esteem will be assessed using the RSES. The RSES is a self-report measure that consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree. The total score ranges from 0 to 30 with higher scores indicating higher self esteem.

Time Frame

baseline and post-treatment (Month 4)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Janet A Lydecker, PhD

Phone

203-785-7210

Email

janet.lydecker@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Teen Power

Phone

203-785-7210

Email

teenpower@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet A Lydecker, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University (Teen Power - Online)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janet Lydecker, Phd

Phone

203-737-4299

Email

janet.lydecker@yale.edu

First Name & Middle Initial & Last Name & Degree

Teen Power

Phone

2037857210

Email

teenpower@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

Because of the sensitive nature of these data, IPD sharing will be limited to requests from other researchers that are reasonable and accompanied by an approved protocol.

Bulimia Nervosa, Overweight or Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial