Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439160
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-20
Brief Title:
Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Exploring the Changes in Social Interaction and Its Protective Features in Anorexia Nervosa
Status:
RECRUITING
Status Verified Date:
2024-06
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 disordersocial phobia is the first or second most common comorbid anxiety in AN ie prevalence rates ranging from 16 to 882 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 componentsskills of people affected by AN
The development of social componentsskills 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 componentsskills 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 disordersocial phobia is the first or second most common comorbid anxiety in AN ie prevalence rates ranging from 16 to 882 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 componentsskills of people affected by AN Therefore we believe it would be relevant to understand whether our treatments change the social componentsskills of the people affected by AN who access our wards multidisciplinary inpatient intensive rehabilitation treatment Moreover it would be important to evaluate the protective role of participants social componentsskills in the changes in their psychopathology Despite our rehabilitative activities not having a specific focus on sociality the activities are conducted on a 11 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 componentsskills 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 componentsskills of people affected by AN
The development of social componentsskills 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 componentsskills 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 componentsskills of people affected by AN
The development of social componentsskills 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?:
None