Targeting Social Function in Anxiety and Eating Disorders

NCT06198023 | Recruiting

• 1 other identifier: STU-2023-1157
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eating Disorders; Anorexia Nervosa; Other Specified Feeding or Eating Disorder; Bulimia Nervosa; Atypical Anorexia Nervosa; Purging (Eating Disorders); Social Anxiety Disorder; Generalized Anxiety Disorder (GAD)

Keywords

social function; social cognition; social processing; psychoeducation; group therapy; group intervention; art therapy; social anxiety

Outcome Measures

Primary Outcomes (14)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Change in depression symptoms

  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).

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

• Change in depression symptoms

  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).

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

• Change in depression symptoms

  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).

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

• Change in depression symptoms

  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).

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

• Change in anxiety symptoms

  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).

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

• Change in anxiety symptoms

  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).

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

• Change in anxiety symptoms

  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).

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

• Change in anxiety symptoms

  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).

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

• Change in overall levels of psychopathology

  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

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

• Change in eating disorder diagnosis

  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.

  baseline and final study visits (approximately 1 year apart)

Secondary Outcomes (18)

• Change in verbal learning and memory

  baseline and final study visits (approximately 1 year apart)

• Change in visuospatial learning and memory

  baseline and final study visits (approximately 1 year apart)

• Change in sense of social connectedness

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

• Change in sense of social connectedness

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

• Change in sense of social connectedness

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

Study Arms (2)

Educational

EXPERIMENTAL

Behavioral: Educational

Interactive

EXPERIMENTAL

Behavioral: Interactive

Interventions

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.

Educational

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.

Interactive

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current inpatient or residential treatment
• Medical instability or safety/suicide risk as determined by the PI

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Multispecialty Psychiatry Clinic

Dallas, Texas, 75247, United States

RECRUITING

Related Publications (1)

• Ryan A, Arthur S, Lieu L, Kallianpur R, Mahmood F, Noebel N, Sherman-Chung M, McAdams CJ. Learning to connect: feasibility, acceptability and experiences in the social domain intervention for eating disorders. J Eat Disord. 2025 Nov 23;13(1):294. doi: 10.1186/s40337-025-01470-0.

  PMID: 41276826 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Phobia, Social; Generalized Anxiety Disorder; Social Adjustment

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Phobic Disorders; Anxiety Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Carrie J McAdams, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ava Ryan

CONTACT

214-648-4617; edresearch@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 10, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)