Efficacy Trial of a Dissonance Based Eating Disorder Program
NCT ID: NCT03796091
Last Updated: 2022-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2018-11-18
2021-04-15
Brief Summary
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Detailed Description
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Prior to each assessment session, participants should:
* Complete the online survey (if not completed prior to each laboratory appointment this will need to be completed at the lab appointment)
* Fast (not consume any food or beverages other than water) for at least 3 hours.
* Refrain from using nicotine for at least 3 hours.
* Refrain from vigorous physical exercise for at least 24 hours.
* Not show any symptoms of acute physical illness for 48 hours. It is important for participants to follow these directions so researchers can gather the most accurate data. If participants forget to follow these guidelines, or if an illness occurs, participants should contact their experimenter to reschedule.
On the day of an assessment session, participants will drive to the assessment location. Participants will receive directions via e-mail prior to each session. During the assessment session, participants will lie down on a laboratory cot for 10 minutes while preparation for electrocardiography (EKG or ECG) occurs. Electrodes will be applied to the chest and torso and lead wires will be attached to the electrodes. Participants' blood pressure will be assessed several times throughout this interval. Next, the experimenter will collect a 5 minute and 30 second recording of participants' cardiovascular data via electrocardiography (ECG or EKG). This data will later be analyzed to examine cardiac function.Next experimenters will assess participants' height and weight.
After each assessment session, participants' eating disorder symptoms, psychological risk factors, and cardiac indices will be evaluated by the research team. If the team determines that symptoms or cardiac indices are atypical and indicate a further need for evaluation, the participant will be contacted via both e-mail and phone to be informed results are atypical and the participant will be referred for further evaluation by a medical provider. If the participant is a minor, this information will be provided both to the participant and to the participant's parent and/or the participant's legal guardian. If participants' symptoms or risk factors worsen significantly over the duration of the trial, participants will also be contacted and provided with referral recommendations.
All participants will receive a comprehensive symptom report at the end of the trial. Referral resources will be provided again at that time if significant eating disorder symptoms remain.
Treatment Conditions: Participants will be randomly assigned to 1 of 3 treatment conditions.
Brochure Treatment Condition: Participants randomly assigned to the educational brochure will receive two educational brochures which discuss eating disorder symptoms. The brochures will also include treatment referral information and recommended resources for persons struggling with disordered eating. The brochure will take approximately 10 minutes to read; follow-up with treatment or self-help referral resources is completely voluntary.
Group Therapy Treatment Conditions: Participants randomly assigned to one of the two group treatment intervention conditions will complete a 4-week group treatment program with 3-8 other women and 2 trained treatment co-facilitators. For approximately 1 hour each week, participants will meet in this group to complete a series of readings, written activities, and verbal activities designed to reduce disordered eating. During the 4 intervention sessions, participants will be asked to analyze the weight and appearance-related messages received from the media, peers, family, romantic partners, and other sources. Participants will also be asked to record, analyze, and evaluate weight and appearance-related thoughts, emotions, and behaviors. Participants will engage in a variety of exercises designed to evaluate the meaning of thinness in our culture and its personal impact. These exercises are designed to combat the detrimental impact of messages which promote thinness.
Other risk factors will also be addressed, depending upon program. Participants may talk about the pressures women receive to focus on appearance. The relationship between these appearance-related pressures and eating disorder symptoms will be explored. Participants will explore the way they compare themselves to others and participate in a series of discussions and activities designed to decrease appearance-based comparisons with others.
After the 4-week program is complete, participants in both intervention conditions will continue to work on homework assignments related to the program for a period of 2-months until the final assessment session.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Educational Brochure
Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Educational Brochure
Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.
Body Project Traditional
Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project group therapy program (Stice \& Shaw, 2001).
Body Project Traditional
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice \& Shaw, 2001).
Body Project Expanded
Participants will complete group therapy for 1-hour per week for 4 weeks consisting of the Body Project Expanded group therapy program (Green et al., 2017).
Body Project Expanded
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).
Interventions
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Educational Brochure
Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.
Body Project Traditional
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice \& Shaw, 2001).
Body Project Expanded
Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).
Eligibility Criteria
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Inclusion Criteria
* Age 15-34
* Postmenarcheal
* Premenopausal
* Subclinical or Clinical Eating Disorder Symptoms
Exclusion Criteria
* Must not be pregnant
* Must be able to read and speak English
15 Years
34 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Cornell College
OTHER
Responsible Party
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Dr. Melinda Green
Principal Investigator
Principal Investigators
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Melinda A Green, PhD
Role: PRINCIPAL_INVESTIGATOR
Green Counseling Services PLLC
Locations
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Cornell College Eating Disorder Institute
Mount Vernon, Iowa, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1516-105-GRE
Identifier Type: -
Identifier Source: org_study_id