Targeting Social Function in Anxiety and Eating Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Educational

    Behavioral

    The 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

    Behavioral

    The 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

60 Participants
are divided into 2 treatment groups
Group A: EducationalExperimental treatment 1 intervention
Group B: InteractiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
pre-intervention (T0) to four months from start of intervention (T4)
2

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.

Time frame
four months from start of intervention (T4) to eight months from start of intervention (T8)
3

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.

Time frame
eight months from start of intervention (T8) to twelve months from start of intervention (T12)
4

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.

Time frame
pre-intervention (T0) to twelve months from start of intervention (T12)

Secondary outcomes

1

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.

Time frame
baseline and final study visits (approximately 1 year apart)
2

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.

Time frame
baseline and final study visits (approximately 1 year apart)
3

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.

Time frame
pre-intervention (T0) to four months from start of intervention (T4)
4

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.

Time frame
four months from start of intervention (T4) to eight months from start of intervention (T8)

Other outcomes

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