Psychological and Psychopathological Characteristics of Patients With Obesity Candidates for Bariatric Surgery

NCT ID: NCT06556459

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

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 severe/pathological 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 and/or 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 severe/pathological obesity requesting bariatric surgery through a baseline assessment and, if applicable, at six and twelve months post-surgery.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Bariatric Surgery

The patient performs:

• psychological clinical interview
• psychodiagnostic examination
• internal medical examination
• blood tests
• electrocardiogram
• bariatric surgery
• surgical visit

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All sex;
• Age ≥18 years
• Diagnosis of grade II or grade III (or pathological) obesity based on body mass index values, respectively, of 35-40 and >40 kg/m²
• Multidisciplinary evaluation aimed at indicating bariatric surgery interventions as per clinical practice
• Provision of written informed consent to participate in the study

Exclusion Criteria

• Age <18 years
• Diagnosis of neurological disorders associated with cognitive decline (such as to impair the execution of psychometric assessment)
• Confirmed pregnancy, breastfeeding, or potential pregnancy with positive serological β- HCG
• Refusal to sign the informed consent to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Raffaelli

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Endocrina e Metabolica

Roma, , Italy

Countries

Italy

Central Contacts

Marco Raffaelli

Role: CONTACT

marco.raffaelli@policlinicogemelli.it

+390630156194

Facility Contacts

Marco Raffaelli

Role: primary

marco.raffaelli@policlinicogemelli.it

+0630156194

Maria Rosaria Magurano

Role: backup

mariarosaria.magurano@policlinicogemelli.it

Other Identifiers

6678

Identifier Type: -

Identifier Source: org_study_id