Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06198023

Conditions

Eating Disorders

Anorexia Nervosa

Bulimia Nervosa

Atypical Anorexia Nervosa

Purging (Eating Disorders)

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Educational

Interactive

Study Details

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

Bulimia Nervosa

Atypical Anorexia Nervosa

Purging (Eating Disorders)

Study ID

NCT06198023

Start date

Feb 28, 2024

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Educational

experimental: Interactive

Interventions

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.

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.

Primary outcome measure

  • Change in eating disorder symptoms [ Time Frame: pre-intervention (T0) to four months from start of intervention (T4) ]
  • Change in eating disorder symptoms [ Time Frame: four months from start of intervention (T4) to eight months from start of intervention (T8) ]
  • Change in eating disorder symptoms [ Time Frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12) ]
  • Change in eating disorder symptoms [ Time Frame: pre-intervention (T0) to twelve months from start of intervention (T12) ]
  • Change in depression symptoms [ Time Frame: pre-intervention (T0) to four months from start of intervention (T4) ]
  • Change in depression symptoms [ Time Frame: four months from start of intervention (T4) to eight months from start of intervention (T8) ]
  • Change in depression symptoms [ Time Frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12) ]
  • Change in depression symptoms [ Time Frame: pre-intervention (T0) to twelve months from start of intervention (T12) ]
  • Change in anxiety symptoms [ Time Frame: pre-intervention (T0) to four months from start of intervention (T4) ]
  • Change in anxiety symptoms [ Time Frame: four months from start of intervention (T4) to eight months from start of intervention (T8) ]
  • Change in anxiety symptoms [ Time Frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12) ]
  • Change in anxiety symptoms [ Time Frame: pre-intervention (T0) to twelve months from start of intervention (T12) ]
  • Change in overall levels of psychopathology [ Time Frame: pre-intervention (T0) and at the last post-intervention follow-up (T12) ]
  • Change in eating disorder diagnosis [ Time Frame: baseline and final study visits (approximately 1 year apart) ]

Central Contacts and Locations

Central contacts

Ava Ryan

214-648-4617edresearch@utsouthwestern.edu

Locations

UT Southwestern Multispecialty Psychiatry Clinic

Recruiting

Dallas, Texas, United States, 75247

Principal Investigator:

Carrie J McAdams

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-05-05.