Efficacy Trial of a Dissonance Based Eating Disorder Program
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

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.
    

Intervention name(s): Educational Brochure; Body Project Traditional; Body Project Expanded
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.; 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).; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled clinical trial with 3 treatment interventions
Masking: None (Open Label)
Primary purpose: Treatment