About this trial
Social processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task.
Participants will:
* attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks * complete a pre-intervention assessment with questionnaires * attend eight sessions of their assigned treatment group over the course of 12 weeks * complete three virtual follow-up assessments 4, 8, and 12 months from their baseline * attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks
Researchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if
* patients can be treated effectively with education alone or if an interactive group component produces additional benefits * cognitive and behavioral task performance are associated with recovery or illness state.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
In the past 12 months, has met DSM-5 criteria met for an eating disorder (Anorexia Nervosa, Atypical Anorexia Nervosa, Bulimia Nervosa, Avoidant-Restrictive Food Intake Disorder, or Other Specified Feeding or Eating Disorder) and/or an anxiety disorder (Generalized Anxiety Disorder, Social Anxiety Disorder)
Between the ages of 18-30
Disqualifiers
Current inpatient or residential treatment
Medical instability or safety/suicide risk as determined by the PI
Trial design
Parallel
Treatments tested in this trial
Educational
BehavioralThe educational intervention is an 8-session series of informational presentations about brain function and altered social processing related to eating disorders. Participants will receive a reflective prompt to complete as homework and will have an opportunity to discuss their responses during the following session.
Interactive
BehavioralThe interactive intervention is an 8-session series of experiential art therapy tasks followed by education about social processing. Participants will complete the tasks as a group or in small teams. Afterward, they will be encouraged to discuss their thoughts and feelings related to their experience. The educational component will include a homework assignment that participants will have the opportunity to discuss at the following session.
Treatment groups
Trial outcomes
Primary outcomes
Change in eating disorder symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6, with higher scores indicating greater severity. Scores of 2 or less are considered typical of normative eating behavior/cognitions, while scores of 3-6 suggest the presence of clinically significant eating disorder symptoms.
Change in eating disorder symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6, with higher scores indicating greater severity. Scores of 2 or less are considered typical of normative eating behavior/cognitions, while scores of 3-6 suggest the presence of clinically significant eating disorder symptoms.
Change in eating disorder symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6, with higher scores indicating greater severity. Scores of 2 or less are considered typical of normative eating behavior/cognitions, while scores of 3-6 suggest the presence of clinically significant eating disorder symptoms.
Change in eating disorder symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) measures the severity of eating disorder symptoms. Possible scores on global eating disorder pathology range from 0 to 6, with higher scores indicating greater severity. Scores of 2 or less are considered typical of normative eating behavior/cognitions, while scores of 3-6 suggest the presence of clinically significant eating disorder symptoms.
Secondary outcomes
Change in verbal learning and memory
California Verbal Learning Test (CVLT-3) is an individually administered assessment that measures both recall and recognition of two lists of words over a number of immediate and delayed memory trials. The CVLT 3 Core Report contains demographics, a core score summary, a scaled score profile, a standard score summary, a process score summary, and demographically adjusted core and standard scores, if selected. Item responses for all recall trials can also be selected for inclusion on the report.
Change in visuospatial learning and memory
Ruff-Light Trail Learning Test (RULIT) is a measure of visuospatial learning and memory. The respondent is given a stimulus card containing a complex configuration of circles interconnected by lines and asked to use an index finger to trace a line connecting the circles from the START to the END. The task is repeated until participants trace the correct path in two consecutive trials. Immediate Memory is assessed by the number of steps correctly completed in Trial 2. Learning is assessed by the number of trials to master the task and the cumulative number of errors across Trials 2 through 10 (or until the task is mastered), and Long-term Recall is evaluated by having the respondent retrace the trail after a 60-minute delay.
Change in sense of social connectedness
The Social Connectedness Scale (SCS) is a self-report questionnaire that measures the extent to which individuals feel connected to others in their social environment. It consists of 20 items that assess four different dimensions of social connectedness that include belongingness, closeness, support, and satisfaction. Individuals rate each item on a 6-point Likert scale, from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate a greater sense of social connectedness.
Change in sense of social connectedness
The Social Connectedness Scale (SCS) is a self-report questionnaire that measures the extent to which individuals feel connected to others in their social environment. It consists of 20 items that assess four different dimensions of social connectedness that include belongingness, closeness, support, and satisfaction. Individuals rate each item on a 6-point Likert scale, from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate a greater sense of social connectedness.
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