Targeting Social Function in Anxiety and Eating Disorders

BEHAVIORAL

Educational

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.

BEHAVIORAL

Interactive

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.

Change in eating disorder symptoms

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

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

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

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

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

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

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

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 depression symptoms

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

The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression symptoms. Each item is rated on a four-point scale (0 = not at all; 1 = several days; 2 = more than half the days; 3 = nearly every day). Possible scores range from 0-27, allowing depression to be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27).

Change in depression symptoms

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

The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression symptoms. Each item is rated on a four-point scale (0 = not at all; 1 = several days; 2 = more than half the days; 3 = nearly every day). Possible scores range from 0-27, allowing depression to be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27).

Change in depression symptoms

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

The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression symptoms. Each item is rated on a four-point scale (0 = not at all; 1 = several days; 2 = more than half the days; 3 = nearly every day). Possible scores range from 0-27, allowing depression to be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27).

Change in depression symptoms

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

The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression symptoms. Each item is rated on a four-point scale (0 = not at all; 1 = several days; 2 = more than half the days; 3 = nearly every day). Possible scores range from 0-27, allowing depression to be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27).

Change in anxiety symptoms

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

The General Anxiety Disorder Scale (GAD-7) is a 7-item measure of anxiety symptoms. Each item is rated on a four-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Possible scores range from 0-21, allowing anxiety to be classified as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21).

Change in anxiety symptoms

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

The General Anxiety Disorder Scale (GAD-7) is a 7-item measure of anxiety symptoms. Each item is rated on a four-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Possible scores range from 0-21, allowing anxiety to be classified as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21).

Change in anxiety symptoms

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

The General Anxiety Disorder Scale (GAD-7) is a 7-item measure of anxiety symptoms. Each item is rated on a four-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Possible scores range from 0-21, allowing anxiety to be classified as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21).

Change in anxiety symptoms

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

The General Anxiety Disorder Scale (GAD-7) is a 7-item measure of anxiety symptoms. Each item is rated on a four-point scale (0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day). Possible scores range from 0-21, allowing anxiety to be classified as minimal (0-4), mild (5-9), moderate (10-14), or severe (15-21).

Change in overall levels of psychopathology

Time frame: pre-intervention (T0) and at the last post-intervention follow-up (T12)

The DSM-5 Cross-Cutting Symptom Measure (DSM-XC) is a 23-item measure of overall levels of psychopathology across 13 psychiatric domains. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The score on each item within a domain should be reviewed. Because additional inquiry is based on the highest score on any item within a domain, the clinician is asked to indicate that score in the "Highest Domain Score" column

Change in eating disorder diagnosis

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

The Eating Disorder Diagnostic Assessment for DSM-5 (EDA-5) is a semi-structured clinical interview meant to assist in the assessment of a feeding or eating disorder according to DSM-5 criteria.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.