Clinical trial NCT06198023: Targeting Social Function in Anxiety and Eating Disorders
Official title: Targeting Social Function to Improve Outcomes in Anxiety and Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Atypical Anorexia Nervosa
Purging (Eating Disorders)
Other Specified Feeding or Eating Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder (GAD)
Keywords: social function
social cognition
social processing
psychoeducation
group therapy
group intervention
art therapy
social anxiety
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Eating disorders are devastating psychiatric disorders that afflict approximately 2% of young women and men. While the specific determining factors in illness progression and recovery remain poorly understood, social environment is known to be closely associated with eating disorders. Onset occurs most commonly in adolescence and young adulthood, times of complex changes in social roles, and social stressors are common both when eating disorders begin and recur. These clinical observations suggest that the brain mechanisms that process social stimuli may differ for people with eating disorders and therefore serve as powerful therapeutic targets. A previous interventional pilot targeting social function in eating disorders through psychoeducation and experiential tasks produced clinical improvements in the patients enrolled. This project will extend those results to evaluate whether the benefits experienced by participants are related to the therapeutic group interaction or can be achieved with education alone. Enrollment will be expanded to include males and individuals with OSFED (Other Specified Feeding and Eating Disorder) diagnoses. Additionally, to improve understanding of eating disorder course of illness, clinical symptoms, psychosocial behaviors, and neuropsychological function will be assessed at baseline and one year later.

Study Overview:

1. Group assignment will be determined based on time of study entry. Enrollment will alternate between interventions once researchers have recruited enough patients to fill a cohort (8-12 people).
2. Participants will attend an in-person baseline study visit to complete clinical interviews, neuropsychological testing, and computerized behavioral tasks.
3. Baseline self-report questionnaires will be completed virtually by participants prior to the first intervention session.
4. Both programs will consist of 8 sessions conducted across 12 weeks. This spacing allows for seasonal flexibility and accommodation of group member needs in order to maximize participation.
5. For participants in the educational arm, all intervention sessions will be completed remotely. Participants in the interactive will attend in-person sessions consisting of an hour-long art activity followed by the same hour-long psychoeducation session received by participants in the educational arm. Participants in both groups will be given homework assignments to complete after each session and invited to discuss their responses in the following session.
6. Participants will complete self-report questionnaires at time points T=4, 8, and 12, measured from the time of their baseline assessment. The T4 follow-up will include an evaluation form to collect participant feedback for the purpose of improving future interventions. Participants will also be asked to provide updates regarding their treatment, weight, medication(s), and similar information in a brief phone call with researchers.
7. After completing their T12 follow-up assessment, participants will attend a final in-person study visit to repeat some of the clinical, neuropsychological, and behavioral measures collected at baseline.

Participants who are unable or unwilling to complete their assigned intervention course will still be invited to complete follow-up assessments and a final study visit. This data will be valuable to the study's aim of better understanding the evolution of eating disorders over time.

Eligibility criteria: 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

Primary outcomes:
measure: Change in eating disorder symptoms
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in eating disorder symptoms
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in eating disorder symptoms
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in eating disorder symptoms
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in depression symptoms
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in depression symptoms
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in depression symptoms
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in depression symptoms
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in anxiety symptoms
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in anxiety symptoms
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in anxiety symptoms
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in anxiety symptoms
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in overall levels of psychopathology
timeFrame: pre-intervention (T0) and at the last post-intervention follow-up (T12)
measure: Change in eating disorder diagnosis
timeFrame: baseline and final study visits (approximately 1 year apart)
Secondary outcomes:
measure: Change in verbal learning and memory
timeFrame: baseline and final study visits (approximately 1 year apart)
measure: Change in visuospatial learning and memory
timeFrame: baseline and final study visits (approximately 1 year apart)
measure: Change in sense of social connectedness
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in sense of social connectedness
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in sense of social connectedness
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in sense of social connectedness
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in perceived social support
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in perceived social support
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in perceived social support
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in perceived social support
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in trait self-esteem
timeFrame: pre-intervention (T0) to four months from start of intervention (T4)
measure: Change in trait self-esteem
timeFrame: four months from start of intervention (T4) to eight months from start of intervention (T8)
measure: Change in trait self-esteem
timeFrame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
measure: Change in trait self-esteem
timeFrame: pre-intervention (T0) to twelve months from start of intervention (T12)
measure: Change in social learning rates
timeFrame: baseline to final study visit (approximately 1 year apart)
measure: Change in social reward learning
timeFrame: baseline to final study visit (approximately 1 year apart)
measure: Change in social learning biases
timeFrame: baseline to final study visit (approximately 1 year apart)
measure: Change in attribution biases
timeFrame: baseline to final study visit (approximately 1 year apart)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Multispecialty Psychiatry Clinic
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Carrie J McAdams, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: