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Efficacy Trial of a Dissonance Based Eating Disorder Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796091
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dr. Melinda Green, Cornell College

Brief 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.

Condition or disease Intervention/treatment Phase
Eating Disorder Behavioral: Educational Brochure Behavioral: Body Project Traditional Behavioral: Body Project Expanded Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled clinical trial with 3 treatment interventions
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Trial of a Dissonance Based Eating Disorder Program
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Active Comparator: Educational Brochure
Participants will read an educational brochure from the National Eating Disorder Association and will receive referral resources.
Behavioral: Educational Brochure
Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.

Active Comparator: 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).
Behavioral: 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).

Active Comparator: 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).
Behavioral: 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).




Primary Outcome Measures :
  1. Rosenberg Self-Esteem Scale (RSE). [ Time Frame: baseline (preintervention) ]
    The Rosenberg Self-Esteem Scale (RSE: Rosenberg, 1965) is a widely used measure designed to assess global feelings of self-worth and self-esteem. Originally designed as a Guttman scale, the RSE is now conceptualized and scored as a Likert scale. The RSE includes 10 items (e.g. "I feel that I'm a person of worth) rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). Higher scores indicate higher levels of self-esteem.

  2. Rosenberg Self-Esteem Scale (RSE). [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Rosenberg Self-Esteem Scale (RSE: Rosenberg, 1965) is a widely used measure designed to assess global feelings of self-worth and self-esteem. Originally designed as a Guttman scale, the RSE is now conceptualized and scored as a Likert scale. The RSE includes 10 items (e.g. "I feel that I'm a person of worth) rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). Higher scores indicate higher levels of self-esteem.

  3. Rosenberg Self-Esteem Scale (RSE). [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Rosenberg Self-Esteem Scale (RSE: Rosenberg, 1965) is a widely used measure designed to assess global feelings of self-worth and self-esteem. Originally designed as a Guttman scale, the RSE is now conceptualized and scored as a Likert scale. The RSE includes 10 items (e.g. "I feel that I'm a person of worth) rated on a four-point scale (1 = strongly disagree, 4 = strongly agree). Higher scores indicate higher levels of self-esteem.

  4. Eating Disorder Examination Questionnaire (EDE-Q). [ Time Frame: baseline (preintervention) ]
    The Eating Disorder Examination-Questionnaire 16.0D is the gold standard semi-structured diagnostic interview for evaluating eating disorder symptoms, adapted from the original Eating Disorder Examination (EDE: Cooper, Cooper, & Fairburn, 1989). The EDE will be used to confirm diagnostic level for participants with clinical symptoms.

  5. Eating Disorder Examination Questionnaire (EDE-Q). [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Eating Disorder Examination-Questionnaire 16.0D is the gold standard semi-structured diagnostic interview for evaluating eating disorder symptoms, adapted from the original Eating Disorder Examination (EDE: Cooper, Cooper, & Fairburn, 1989). The EDE will be used to confirm diagnostic level for participants with clinical symptoms.

  6. Eating Disorder Examination Questionnaire (EDE-Q). [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Eating Disorder Examination-Questionnaire 16.0D is the gold standard semi-structured diagnostic interview for evaluating eating disorder symptoms, adapted from the original Eating Disorder Examination (EDE: Cooper, Cooper, & Fairburn, 1989). The EDE will be used to confirm diagnostic level for participants with clinical symptoms.

  7. Body Shape Questionnaire (BSQ). [ Time Frame: baseline (preintervention) ]
    The Body Shape Questionnaire (BSQ: Cooper, Taylor, Cooper, & Fairburn, 1986) is a 34-item measure designed to assess body dissatisfaction. Items are measured on a 6-point Likert scale designed to measure the frequency of negative body-related thoughts (1= never, 6 = always). Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

  8. Body Shape Questionnaire (BSQ). [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Body Shape Questionnaire (BSQ: Cooper, Taylor, Cooper, & Fairburn, 1986) is a 34-item measure designed to assess body dissatisfaction. Items are measured on a 6-point Likert scale designed to measure the frequency of negative body-related thoughts (1= never, 6 = always). Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

  9. Body Shape Questionnaire (BSQ). [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Body Shape Questionnaire (BSQ: Cooper, Taylor, Cooper, & Fairburn, 1986) is a 34-item measure designed to assess body dissatisfaction. Items are measured on a 6-point Likert scale designed to measure the frequency of negative body-related thoughts (1= never, 6 = always). Higher scores indicate higher frequency of negative body-related thoughts and higher levels of body dissatisfaction.

  10. Social Comparison Rating Scale (SCRS). [ Time Frame: baseline (preintervention) ]
    The Social Comparison Rating Scale (SCRS: Allan & Gilbert, 1995) is an 11-item scale designed to assess perception of social rank. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

  11. Social Comparison Rating Scale (SCRS). [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Social Comparison Rating Scale (SCRS: Allan & Gilbert, 1995) is an 11-item scale designed to assess perception of social rank. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

  12. Social Comparison Rating Scale (SCRS). [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Social Comparison Rating Scale (SCRS: Allan & Gilbert, 1995) is an 11-item scale designed to assess perception of social rank. The scale consists of a series of bipolar adjectives (e.g., inferior/superior) separated by the numbers 1 through 10. For each adjective pair, participants are asked to rank themselves in comparison to others. A score around 60 indicates a person, on average, sees themselves approximately equal to others. Higher scores indicate higher levels of favorable social comparison and higher perceived social rank.

  13. Self-Objectification Questionnaire (SOQ) [ Time Frame: baseline (preintervention) ]
    The Self-Objectification Questionnaire (SOQ: Fredrickson et al., 1998) will be used to assess trait self-objectification. The SOQ is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in physical self-concept (Fredrickson et al., 1998). Participants are asked to rank 5 appearance-based attributes (e.g., physical attractiveness) and 5 competence-based attributes (e.g., physical coordination) in order of their impact on physical self-concept. Attributes are ranked from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

  14. Self-Objectification Questionnaire (SOQ) [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Self-Objectification Questionnaire (SOQ: Fredrickson et al., 1998) will be used to assess trait self-objectification. The SOQ is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in physical self-concept (Fredrickson et al., 1998). Participants are asked to rank 5 appearance-based attributes (e.g., physical attractiveness) and 5 competence-based attributes (e.g., physical coordination) in order of their impact on physical self-concept. Attributes are ranked from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

  15. Self-Objectification Questionnaire (SOQ) [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Self-Objectification Questionnaire (SOQ: Fredrickson et al., 1998) will be used to assess trait self-objectification. The SOQ is a 10-item self-report inventory designed to assess the relative importance of body competence versus body appearance in physical self-concept (Fredrickson et al., 1998). Participants are asked to rank 5 appearance-based attributes (e.g., physical attractiveness) and 5 competence-based attributes (e.g., physical coordination) in order of their impact on physical self-concept. Attributes are ranked from 0 to 9 with higher scores representing higher importance. An overall trait self-objectification score is computed by summing competence and appearance ratings and subtracting the sum of competence ratings from the sum of appearance ratings. Resulting scores range from -25 to 25. Higher scores denote higher levels of trait self-objectification.

  16. Ideal Body Stereotype Scale - Revised. [ Time Frame: baseline (preintervention) ]
    The Ideal Body Stereotype Scale - Revised (IBSS-R: Stice, 2001) will be used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Higher scores indicate higher levels of thin-ideal internalization.

  17. Ideal Body Stereotype Scale - Revised. [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Ideal Body Stereotype Scale - Revised (IBSS-R: Stice, 2001) will be used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Higher scores indicate higher levels of thin-ideal internalization.

  18. Ideal Body Stereotype Scale - Revised. [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Ideal Body Stereotype Scale - Revised (IBSS-R: Stice, 2001) will be used to assess the extent to which participants internalized the cultural feminine thin-ideal. The IBSS-R is a self-report inventory which asks participants to report their level of agreement with 6 statements which indicate what attractive women look like on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Responses are averaged to compute a total score. Higher scores indicate higher levels of thin-ideal internalization.

  19. State Trait Anxiety Inventory - Form Y. [ Time Frame: baseline (preintervention) ]
    The State Trait Anxiety Inventory- Form Y (STAI: Spielberger, Gorsuch, & Lushene, 1970) is a 20-item self-report measure designed to assess level of trait anxiety. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

  20. State Trait Anxiety Inventory - Form Y. [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The State Trait Anxiety Inventory- Form Y (STAI: Spielberger, Gorsuch, & Lushene, 1970) is a 20-item self-report measure designed to assess level of trait anxiety. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

  21. State Trait Anxiety Inventory - Form Y. [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The State Trait Anxiety Inventory- Form Y (STAI: Spielberger, Gorsuch, & Lushene, 1970) is a 20-item self-report measure designed to assess level of trait anxiety. Each item consists of a statement which assesses feelings of anxiety or relaxation on a 4-point scale ranging from 1 (not at all) to 4 (very much so). Scores range from 20 to 80. Higher scores indicate higher levels of anxiety.

  22. Body Mass Index: [ Time Frame: baseline (preintervention) ]
    Body mass index (BMI) will be calculated based on height and weight data [weight (kg)/height (m2)] (see Garrow & Webster, 1985). Weight and height will be combined to report BMI in kg/m^2.

  23. Body Mass Index: [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    Body mass index (BMI) will be calculated based on height and weight data [weight (kg)/height (m2)] (see Garrow & Webster, 1985). Weight and height will be combined to report BMI in kg/m^2.

  24. Body Mass Index: [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    Body mass index (BMI) will be calculated based on height and weight data [weight (kg)/height (m2)] (see Garrow & Webster, 1985). Weight and height will be combined to report BMI in kg/m^2.

  25. Systolic Blood Pressure [ Time Frame: baseline (preintervention) ]
    Systolic blood pressure will be examined via an Omron blood pressure monitor.

  26. Systolic Blood Pressure [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    Systolic blood pressure will be examined via an Omron blood pressure monitor.

  27. Systolic Blood Pressure [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    Systolic blood pressure will be examined via an Omron blood pressure monitor.

  28. Diastolic Blood Pressure [ Time Frame: baseline (preintervention) ]
    Diastolic blood pressure will be examined via an Omron blood pressure monitor.

  29. Diastolic Blood Pressure [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    Diastolic blood pressure will be examined via an Omron blood pressure monitor.

  30. Diastolic Blood Pressure [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    Diastolic blood pressure will be examined via an Omron blood pressure monitor.

  31. Positive and Negative Affect Scale [ Time Frame: baseline (preintervention) ]
    The Positive and Negative Affect Scale (Watson, Clark, & Tellegan, 1988) is a 20-item self-report measure to measure two aspects of mood and is comprised of two subscales: positive affect and negative affect. Higher scores on both subscales indicate a higher level of that type of affect. Each item consists of a word that describes different feelings and emotions and participants are asked to rate the extent they felt that way over the past week, ranging from 1 (very slightly or not at all) to 5 (extremely). Some items are reverse scored. Scores range from 10 to 50 on each subscale.

  32. Positive and Negative Affect Scale [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The Positive and Negative Affect Scale (Watson, Clark, & Tellegan, 1988) is a 20-item self-report measure to measure two aspects of mood and is comprised of two subscales: positive affect and negative affect. Higher scores on both subscales indicate a higher level of that type of affect. Each item consists of a word that describes different feelings and emotions and participants are asked to rate the extent they felt that way over the past week, ranging from 1 (very slightly or not at all) to 5 (extremely). Some items are reverse scored. Scores range from 10 to 50 on each subscale.

  33. Positive and Negative Affect Scale [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The Positive and Negative Affect Scale (Watson, Clark, & Tellegan, 1988) is a 20-item self-report measure to measure two aspects of mood and is comprised of two subscales: positive affect and negative affect. Higher scores on both subscales indicate a higher level of that type of affect. Each item consists of a word that describes different feelings and emotions and participants are asked to rate the extent they felt that way over the past week, ranging from 1 (very slightly or not at all) to 5 (extremely). Some items are reverse scored. Scores range from 10 to 50 on each subscale.

  34. Mean R Wave Amplitude [ Time Frame: baseline (preintervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

  35. Mean R Wave Amplitude [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

  36. Mean R Wave Amplitude [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Mean R wave amplitude represents ventricular depolarization and is measured in millivolts. Higher magnitudes indicated increased polarity associated with an increased force of ventricular contraction.

  37. QT Interval Length [ Time Frame: baseline (preintervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.

  38. QT Interval Length [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.

  39. QT Interval Length [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. QT interval length represents the length of ventricular depolarization and repolarization and is measured in msec.

  40. High Frequency Spectral Power [ Time Frame: baseline (preintervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Increased high frequency spectral power represents increased vagal input to the heart.

  41. High Frequency Spectral Power [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Increased high frequency spectral power represents increased vagal input to the heart.

  42. High Frequency Spectral Power [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. Increased high frequency spectral power represents increased vagal input to the heart. It is measured in msec2.

  43. Low Frequency High Frequency Spectral Power Ratio [ Time Frame: baseline (preintervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. A high low frequency to high frequency spectral ratio represents increased sympathetic input to the heart. It is measured in msec2.

  44. Low Frequency High Frequency Spectral Power Ratio [ Time Frame: postintervention (approximately 4 weeks after the start of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. A high low frequency to high frequency spectral ratio represents increased sympathetic input to the heart. It is measured in msec2.

  45. Low Frequency High Frequency Spectral Power Ratio [ Time Frame: follow-up (approximately 8 weeks after the conclusion of each intervention) ]
    The ECG signal will be acquired via PowerLab 16/35 psychophysiological data acquisition system with a sampling rate of 1000 Hz. Hardware setup will include an ECG100C amplifier with a 35Hz LPN filter and a .5Hz HP filter. HRV data and ECG data will be analyzed via PowerLab LabChart 8 software. Removable electrodes will be placed on participants in a lead II chest configuration. A high low frequency to high frequency spectral ratio represents increased sympathetic input to the heart. It is measured in msec2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796091


Contacts
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Contact: Melinda A Green, PhD 319-895-4313 mgreen@cornellcollege.edu
Contact: Linden Miles, BA 319-440-9727 lmiles@cornellcollege.edu

Locations
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United States, Iowa
Cornell College Eating Disorder Institute Recruiting
Mount Vernon, Iowa, United States, 52314
Contact: Melinda A Green, PhD    319-895-4313    mgreen@cornellcollege.edu   
Contact: Linden Miles, BA    319-440-9727    lmiles@cornellcollege.edu   
Sponsors and Collaborators
Cornell College
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Melinda A Green, PhD Cornell College

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Responsible Party: Dr. Melinda Green, Principal Investigator, Cornell College
ClinicalTrials.gov Identifier: NCT03796091     History of Changes
Other Study ID Numbers: 1516-105-GRE
R15MH113044 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available to other researchers upon request and subject to signed confidentiality agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon request with 5 years of study completion.
Access Criteria: Must sign confidentiality agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders