Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:25 AM
Study NCT ID:
NCT06439160
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2024-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Sponsor:
Istituto Auxologico Italiano
Organization:
Study Overview
Official Title:
Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2025-04
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:
SOCINTERACAN
Brief Summary:
Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN.
The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs.
The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs.
Detailed Description:
Anorexia Nervosa (AN) is an eating disorder often characterised by restriction of food intake, being underweight, body image uneasiness, and the possibility of binge eating, purging, fasting behaviours, and excessive exercising. AN is of relevance for the health care system because of the high mortality rates, high psychiatric comorbidity, high suicide risk, and because of the high costs for the health system. Despite weight and eating habits being one, and perhaps the most recognizable, components of AN, AN is a multidimensional disease. For example, individuals affected by AN might show psychological suffering, such as depression and anxiety. For example, social anxiety disorder/social phobia is the first or second most common comorbid anxiety in AN (i.e. prevalence rates ranging from 16% to 88.2% in AN against 12% in the general population). Moreover, the highest the level of social anxiety the highest the severity of the eating disorder psychopathology. This latter component resonates with findings on the difficulties observed in people affected by AN in creating and maintaining satisfactory relationships with others. These evidences tell us the importance to take into account the social components/skills of people affected by AN. Therefore, we believe it would be relevant to understand whether our treatments change the social components/skills of the people affected by AN who access our ward's multidisciplinary inpatient intensive rehabilitation treatment. Moreover, it would be important to evaluate the protective role of participants' social components/skills in the changes in their psychopathology. Despite our rehabilitative activities not having a specific focus on sociality, the activities are conducted on a 1:1 or group basis. This means that our activities have an intrinsic relational and socializing value.
The purpose of the study lays on two outcomes:
* Primary outcome: evaluation of the short-term effects (T0 vs T1) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.
* Secondary outcome: evaluation of the long-term effects (T0 vs T2) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.
The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs
The purpose of the study lays on two outcomes:
* Primary outcome: evaluation of the short-term effects (T0 vs T1) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.
* Secondary outcome: evaluation of the long-term effects (T0 vs T2) of the multidisciplinary inpatient intensive rehabilitation treatment on the social components/skills of people affected by AN.
The development of social components/skills of people affected by AN during their recovery can be considered as a protective factor for future relapse. This would be of relevance for the creation of rehabilitative programs
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?: