N/A N=180 Randomized Treatment

Efficacy Trial of a Dissonance Based Eating Disorder Program

Eating Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03796091 ↗

Enrolled (actual)

180

Serious AEs

1.7%

Results posted

Dec 2022

Primary outcome: Primary: Rosenberg Self-Esteem Scale (RSE). — 22.71; 22.50; 22.62 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Educational Brochure (Behavioral); Body Project Traditional (Behavioral); Body Project Expanded (Behavioral)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Cornell College
Primary completion: Apr 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Rosenberg Self-Esteem Scale (RSE).	24.55; 25.55; 26.60	—
PRIMARY Rosenberg Self-Esteem Scale (RSE).	24.55; 25.55; 26.60	—
PRIMARY Rosenberg Self-Esteem Scale (RSE).	24.55; 25.55; 26.60	—
PRIMARY Eating Disorder Examination Questionnaire (EDE-Q).	3.74; 2.73; 2.78	—
PRIMARY Eating Disorder Examination Questionnaire (EDE-Q).	3.74; 2.73; 2.78	—
PRIMARY Eating Disorder Examination Questionnaire (EDE-Q).	3.74; 2.73; 2.78	—
PRIMARY Body Shape Questionnaire (BSQ).	129.51; 105.19; 105.29	—
PRIMARY Body Shape Questionnaire (BSQ).	129.51; 105.19; 105.29	—
PRIMARY Body Shape Questionnaire (BSQ).	129.51; 105.19; 105.29	—
PRIMARY Social Comparison Rating Scale (SCRS).	46.28; 53.39; 53.18	—
PRIMARY Social Comparison Rating Scale (SCRS).	46.28; 53.39; 53.18	—
PRIMARY Social Comparison Rating Scale (SCRS).	46.28; 53.39; 53.18	—
PRIMARY Self-Objectification Questionnaire (SOQ)	9.80; 2.81; 1.78	—
PRIMARY Self-Objectification Questionnaire (SOQ)	9.80; 2.81; 1.78	—
PRIMARY Self-Objectification Questionnaire (SOQ)	9.80; 2.81; 1.78	—
PRIMARY Ideal Body Stereotype Scale - Revised.	3.76; 3.34; 3.46	—
PRIMARY Ideal Body Stereotype Scale - Revised.	3.76; 3.34; 3.46	—
PRIMARY Ideal Body Stereotype Scale - Revised.	3.76; 3.34; 3.46	—
PRIMARY State Trait Anxiety Inventory - Form Y.	55.63; 51.63; 52.58	—
PRIMARY State Trait Anxiety Inventory - Form Y.	55.63; 51.63; 52.58	—
PRIMARY State Trait Anxiety Inventory - Form Y.	55.63; 51.63; 52.58	—
PRIMARY Positive and Negative Affect Scale - Positive Affect	26.60; 27.84; 27.98	—
PRIMARY Positive and Negative Affect Scale - Positive Affect	26.60; 27.84; 27.98	—
PRIMARY Positive and Negative Affect Scale - Positive Affect	26.60; 27.84; 27.98	—
PRIMARY Mean R Wave Amplitude	1.26; 1.14; 1.12	—
PRIMARY Mean R Wave Amplitude	1.26; 1.14; 1.12	—
PRIMARY Mean R Wave Amplitude	1.26; 1.14; 1.12	—
PRIMARY QT Interval Length	.38; .38; .38	—
PRIMARY QT Interval Length	.38; .38; .38	—
PRIMARY QT Interval Length	.38; .38; .38	—
PRIMARY Vagal Cardiac Tone - High Frequency Spectral Power	51.65; 56.60; 58.81	—
PRIMARY Vagal Cardiac Tone - High Frequency Spectral Power	51.65; 56.60; 58.81	—
PRIMARY Vagal Cardiac Tone - High Frequency Spectral Power	51.65; 56.60; 58.81	—
PRIMARY Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio	1.54; 1.86; 1.32	—
PRIMARY Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio	1.54; 1.86; 1.32	—
PRIMARY Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio	1.54; 1.86; 1.32	—
PRIMARY Positive and Negative Affect Scale - Negative Affect	28.50; 24.24; 25.00	—
PRIMARY Positive and Negative Affect Scale - Negative Affect	28.50; 24.24; 25.00	—
PRIMARY Positive and Negative Affect Scale - Negative Affect	28.50; 24.24; 25.00	—

Summary

The purpose of this clinical trial is to investigate whether symptoms of disordered eating change among participants who complete an intervention. Participants will be randomly assigned to one of three intervention conditions and will undergo assessments of symptoms before, after, and 2 months after each intervention. Investigators are evaluating which interventions are most effective in reducing eating disorder symptoms and disorder-related psychological and cardiac risk factors.

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria
Women
Age 15-34
Postmenarcheal
Premenopausal
Subclinical or Clinical Eating Disorder Symptoms

Exclusion Criteria

Exclusion Criteria
Must get physician clearance to participate if at medically high risk as defined in the protocol
Must not be pregnant
Must be able to read and speak English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03796091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.