Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556459
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Psychological and Psychopathological Characteristics of Patients With Obesity Candidates for Bariatric Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Psychological and Psychopathological Characteristics of Patients With Severe or Pathological Obesity Candidates for Bariatric Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSICOBAR
Brief Summary:
Patients with obesity who are candidates for bariatric surgery may exhibit high rates of psychological symptoms mostly anxiety and depression and even full-blown mental disorders The etiopathogenesis of this association has been variously investigated and among the various factors the presence of systemic inflammation even if low-grade seems to be an underlying mechanism for both conditions These associations have been shown to have a significant impact from both a clinical perspective and regarding the outcomes of the surgery itself Worse outcomes have been described in individuals with anxiety-depressive syndromes or mood disorders However additional impacts on treatment can also result from the presence of dysfunctional personality traits and early traumatic experiences reported in about 50 of individuals with severepathological obesity which in turn correlate with pathological eating behaviors in a high percentage of cases
Studies conducted in various countries show that about 40 of all patients undergoing bariatric surgery have at least one psychiatric diagnosis with depressive disorders anxiety disorders and eating disorders being the three most common diagnoses
Most studies on bariatric patients have focused on factors predisposing to severe obesity or predictive of surgical outcomes and post-surgery progress but often lack a more precise psychological and psychopathological characterization of this patient population Targeted studies with a longitudinal design that include long-term post-surgery follow-up are necessary to clarify the actual role of these factors as well as their interaction with other pathophysiological mechanisms involved in the clinical presentation and response to various treatment strategies Identifying new therapeutic targets during the preoperative evaluation process could in fact contribute to improving clinical and post-surgical outcomes Despite bariatric surgery demonstrating a positive short-term impact on weight-related comorbidities and functioning levels particularly in social relationships the emergence of unique and peculiar psychosocial problems andor concerns in the postoperative follow-up has been reported In a 10-year longitudinal study a significant increase in mental health service access was observed following bariatric surgery especially among those with a positive psychiatric history before the surgery
Besides weight loss surgical outcomes should include improvements in metabolic status and medical comorbidities increased quality of life and better psychosocial and behavioral functioning Even in a patient with excellent postoperative weight loss psychosocial problems such as disruptions in interpersonal relationships body image dissatisfaction substance use or suicidal ideation may arise
Therefore this study aims to investigate the sociodemographic clinical personality psychological and psychopathological characteristics of patients with severepathological obesity requesting bariatric surgery through a baseline assessment and if applicable at six and twelve months post-surgery
Studies conducted in various countries show that about 40 of all patients undergoing bariatric surgery have at least one psychiatric diagnosis with depressive disorders anxiety disorders and eating disorders being the three most common diagnoses
Most studies on bariatric patients have focused on factors predisposing to severe obesity or predictive of surgical outcomes and post-surgery progress but often lack a more precise psychological and psychopathological characterization of this patient population Targeted studies with a longitudinal design that include long-term post-surgery follow-up are necessary to clarify the actual role of these factors as well as their interaction with other pathophysiological mechanisms involved in the clinical presentation and response to various treatment strategies Identifying new therapeutic targets during the preoperative evaluation process could in fact contribute to improving clinical and post-surgical outcomes Despite bariatric surgery demonstrating a positive short-term impact on weight-related comorbidities and functioning levels particularly in social relationships the emergence of unique and peculiar psychosocial problems andor concerns in the postoperative follow-up has been reported In a 10-year longitudinal study a significant increase in mental health service access was observed following bariatric surgery especially among those with a positive psychiatric history before the surgery
Besides weight loss surgical outcomes should include improvements in metabolic status and medical comorbidities increased quality of life and better psychosocial and behavioral functioning Even in a patient with excellent postoperative weight loss psychosocial problems such as disruptions in interpersonal relationships body image dissatisfaction substance use or suicidal ideation may arise
Therefore this study aims to investigate the sociodemographic clinical personality psychological and psychopathological characteristics of patients with severepathological obesity requesting bariatric surgery through a baseline assessment and if applicable at six and twelve months post-surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None