Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198023
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-12-07
Brief Title:
Targeting Social Function to Improve Outcomes in Eating Disorders
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Targeting Social Function to Improve Outcomes in Eating Disorders
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SF-ED
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
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 T4 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 medications 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 studys aim of better understanding the evolution of eating disorders over time
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 T4 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 medications 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 studys aim of better understanding the evolution of eating disorders over time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None