Eating DisordersSFNCT06198023
Targeting Social Function in Anxiety and Eating Disorders
A study testing Educational and Interactive in people with Eating Disorders and Anorexia Nervosa, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- Educational and Interactive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current inpatient or residential treatment
- Medical instability or safety/suicide risk as determined by the PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Multispecialty Psychiatry Clinic
Dallas, Texas, 75247
Carrie J McAdams, MD PhD
Carrie J McAdams
About this study
Official title: Targeting Social Function to Improve Outcomes in Anxiety and Eating Disorders
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:
Read more
- 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.
Read the 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:
- 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).
- Participants will attend an in-person baseline study visit to complete clinical interviews, neuropsychological testing, and computerized behavioral tasks.
- Baseline self-report questionnaires will be completed virtually by participants prior to the first intervention session.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Atypical Anorexia Nervosa, Purging (Eating Disorders), Other Specified Feeding or Eating Disorder
- Being tested
- Educational, Interactive
- Keywords
- social function, social cognition, social processing, psychoeducation, group therapy, group intervention, art therapy, social anxiety
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Phobia, Social, Generalized Anxiety Disorder, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalBehavioural
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.
InteractiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational | Experimental | Not described Receives: Behavioral: Educational |
| Interactive | Experimental | Not described Receives: Behavioral: Interactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: baseline and final study visits (approximately 1 year apart)
Secondary outcomes (18)
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.
Measured: baseline and final study visits (approximately 1 year apart)
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.
Measured: baseline and final study visits (approximately 1 year apart)
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.
Measured: pre-intervention (T0) to four months from start of intervention (T4)
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.
Measured: four months from start of intervention (T4) to eight months from start of intervention (T8)
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.
Measured: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
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.
Measured: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in perceived social support
The Multidimensional Scale of Perceived Social Support is a 12-item measure of perceived adequacy of social support from three sources -- family, friends, \& significant other -- using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Measured: pre-intervention (T0) to four months from start of intervention (T4)
Change in perceived social support
The Multidimensional Scale of Perceived Social Support is a 12-item measure of perceived adequacy of social support from three sources -- family, friends, \& significant other -- using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Measured: four months from start of intervention (T4) to eight months from start of intervention (T8)
Change in perceived social support
The Multidimensional Scale of Perceived Social Support is a 12-item measure of perceived adequacy of social support from three sources -- family, friends, \& significant other -- using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Measured: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
Change in perceived social support
The Multidimensional Scale of Perceived Social Support is a 12-item measure of perceived adequacy of social support from three sources -- family, friends, \& significant other -- using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Measured: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in trait self-esteem
Rosenberg trait self-esteem Scale (TSE) is a 10-item measure of global self-worth. Each item is rated on a four-point Likert scale from (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree) and five items are reverse scored. Higher scores indicate higher self-esteem.
Measured: pre-intervention (T0) to four months from start of intervention (T4)
Change in trait self-esteem
Rosenberg trait self-esteem Scale (TSE) is a 10-item measure of global self-worth. Each item is rated on a four-point Likert scale from (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree) and five items are reverse scored. Higher scores indicate higher self-esteem.
Measured: four months from start of intervention (T4) to eight months from start of intervention (T8)
Change in trait self-esteem
Rosenberg trait self-esteem Scale (TSE) is a 10-item measure of global self-worth. Each item is rated on a four-point Likert scale from (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree) and five items are reverse scored. Higher scores indicate higher self-esteem.
Measured: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
Change in trait self-esteem
Rosenberg trait self-esteem Scale (TSE) is a 10-item measure of global self-worth. Each item is rated on a four-point Likert scale from (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree) and five items are reverse scored. Higher scores indicate higher self-esteem.
Measured: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in social learning rates
Cyberball is is an online ball-tossing game that participants believe they are playing with three others. In the version we are using, one player (good) preferentially includes the participant, one (neutral) is equitable, and another player (bad) stops throwing the ball to the participant. Changes in the percentage of throws to each type of player indicate responsivity to social learning. The percentage of throws to the good player will increase while the percentage of throws to the bad player will decrease as participants become more attuned to valence of social interactions.
Measured: baseline to final study visit (approximately 1 year apart)
Change in social reward learning
The Trust Game is a tend-round economic game in which two players take turns acting as "investor" and "trustee." The investor is given $20 and sends a portion to the trustee. The trustee receives three times the invested amount and returns some amount to the investor. This task provides total amounts earned; larger amounts indicate more attunement to the partner's behavior. We hypothesize that this will increase after the intervention due to improved sensitivity to others.
Measured: baseline to final study visit (approximately 1 year apart)
Change in social learning biases
The Evaluation Learning Task presents participants with 6 computer personas across two conditions (self-referential or other-referential). Participants are given word pairs (e.g. 'witty' vs. 'dull') and are asked to guess which word the computer persona would use to describe them (SR) or 'George' (OR). Using the feedback on their selections (correct or incorrect), they must decide whether the computer persona liked or disliked them and to what degree (%). Participant response times and proportion of correct responses in each condition (like, neutral, or dislike) are used to evaluate learning rates and biases in each condition.
Measured: baseline to final study visit (approximately 1 year apart)
Change in attribution biases
The Causal Attribution Task measures latent tendency to attribute positive and negative everyday events to internal (vs external) and global (vs specific) causes.
Measured: baseline to final study visit (approximately 1 year apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start28 Feb 2024
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie McAdams, University of Texas Southwestern Medical Center
- Investigators
- Carrie J McAdams, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198023
- Sponsor's protocol ID
- STU-2023-1157
- Acronym
- SF
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41276826
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Social Function to Improve Outcomes in Anxiety and Eating Disorders
- ClinicalTrials.gov ID
- NCT06198023
- Acronym / sponsor ID
- SF / STU-2023-1157
- Conditions
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Atypical Anorexia Nervosa, Purging (Eating Disorders), Other Specified Feeding or Eating Disorder
- Keywords
- social function, social cognition, social processing, psychoeducation, group therapy, group intervention, art therapy, social anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Participants will attend an in-person baseline study visit to complete clinical interviews, neuropsychological testing, and computerized behavioral tasks.
- Baseline self-report questionnaires will be completed virtually by participants prior to the first intervention session.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational | Experimental | Behavioral: Educational |
| Interactive | Experimental | Behavioral: Interactive |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Current inpatient or residential treatment
- Medical instability or safety/suicide risk as determined by the PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalThe 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. | Behavioural | Educational |
| InteractiveThe 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. | Behavioural | Interactive |
Primary outcome
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.
18 secondary outcomes
Change in verbal learning and memory
Time frame: baseline and final study visits (approximately 1 year apart)
Change in visuospatial learning and memory
Time frame: baseline and final study visits (approximately 1 year apart)
Change in sense of social connectedness
Time frame: pre-intervention (T0) to four months from start of intervention (T4)
Change in sense of social connectedness
Time frame: four months from start of intervention (T4) to eight months from start of intervention (T8)
Change in sense of social connectedness
Time frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
Change in sense of social connectedness
Time frame: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in perceived social support
Time frame: pre-intervention (T0) to four months from start of intervention (T4)
Change in perceived social support
Time frame: four months from start of intervention (T4) to eight months from start of intervention (T8)
Change in perceived social support
Time frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
Change in perceived social support
Time frame: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in trait self-esteem
Time frame: pre-intervention (T0) to four months from start of intervention (T4)
Change in trait self-esteem
Time frame: four months from start of intervention (T4) to eight months from start of intervention (T8)
Change in trait self-esteem
Time frame: eight months from start of intervention (T8) to twelve months from start of intervention (T12)
Change in trait self-esteem
Time frame: pre-intervention (T0) to twelve months from start of intervention (T12)
Change in social learning rates
Time frame: baseline to final study visit (approximately 1 year apart)
Change in social reward learning
Time frame: baseline to final study visit (approximately 1 year apart)
Change in social learning biases
Time frame: baseline to final study visit (approximately 1 year apart)
Change in attribution biases
Time frame: baseline to final study visit (approximately 1 year apart)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 41276826Ryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie J McAdams, MD PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and Interactive in people with Eating Disorders and Anorexia Nervosa, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ava Ryan (214-648-4617, edresearch@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating disorder symptoms (time frame: pre-intervention (T0) to four months from start of intervention (T4)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.