Clinical trial NCT03796091: Efficacy Trial of a Dissonance Based Eating Disorder Program
Official title: Efficacy Trial of a Dissonance Based Eating Disorder Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Lead sponsor: Cornell College
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-01-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial with 3 treatment interventions
Primary purpose: TREATMENT

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.

Detailed description: Assessment Sessions (Preintervention, Postintervention, 2-month follow-up): Participants in all conditions will participate in a series of 3 assessment sessions. Prior to each session, participants will complete online questions assessing eating disorder symptoms and associated psychological risk factors. This process will take approximately 40 minutes. Next participants will report to the laboratory at their scheduled appointment time to have their cardiac function assessed via blood pressure measurements and electrocardiography (EKG or ECG). Participants' height and weight will also be recorded.

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.

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

Primary outcomes:
measure: Rosenberg Self-Esteem Scale (RSE).
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Rosenberg Self-Esteem Scale (RSE).
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Rosenberg Self-Esteem Scale (RSE).
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Eating Disorder Examination Questionnaire (EDE-Q).
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Eating Disorder Examination Questionnaire (EDE-Q).
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Eating Disorder Examination Questionnaire (EDE-Q).
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Body Shape Questionnaire (BSQ).
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Body Shape Questionnaire (BSQ).
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Body Shape Questionnaire (BSQ).
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Social Comparison Rating Scale (SCRS).
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Social Comparison Rating Scale (SCRS).
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Social Comparison Rating Scale (SCRS).
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Self-Objectification Questionnaire (SOQ)
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Self-Objectification Questionnaire (SOQ)
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Self-Objectification Questionnaire (SOQ)
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Ideal Body Stereotype Scale - Revised.
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Ideal Body Stereotype Scale - Revised.
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Ideal Body Stereotype Scale - Revised.
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: State Trait Anxiety Inventory - Form Y.
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: State Trait Anxiety Inventory - Form Y.
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: State Trait Anxiety Inventory - Form Y.
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Positive and Negative Affect Scale - Positive Affect
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Positive and Negative Affect Scale - Positive Affect
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Positive and Negative Affect Scale - Positive Affect
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Mean R Wave Amplitude
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Mean R Wave Amplitude
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Mean R Wave Amplitude
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: QT Interval Length
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: QT Interval Length
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: QT Interval Length
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Vagal Cardiac Tone - High Frequency Spectral Power
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Vagal Cardiac Tone - High Frequency Spectral Power
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Vagal Cardiac Tone - High Frequency Spectral Power
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Sympathetic Cardiac Tone - Low Frequency High Frequency Spectral Power Ratio
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
measure: Positive and Negative Affect Scale - Negative Affect
timeFrame: Baseline assessments occurred after screening and prior to the delivery of any interventions.
measure: Positive and Negative Affect Scale - Negative Affect
timeFrame: Postintervention assessments were conducted approximately 4 weeks following the baseline assessment.
measure: Positive and Negative Affect Scale - Negative Affect
timeFrame: Follow-up assessments began approximately 8 weeks after the postintervention assessment.
Secondary outcomes:
Other outcomes:
Locations:
city: Mount Vernon
country: United States
facility: Cornell College Eating Disorder Institute
state: Iowa
Study officials:
affiliation: Green Counseling Services PLLC
name: Melinda A Green, PhD
role: PRINCIPAL_INVESTIGATOR
References: