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

Official title

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

Overview

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.

Interventions

• Procedure Bariatric Surgery
  The patient performs: * psychological clinical interview * psychodiagnostic examination * internal medical examination * blood tests * electrocardiogram * bariatric surgery * surgical visit

Primary outcome measures

• Evaluation of anxiety and depressive symptoms with Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 Questionnaire (GAD-7), Beck's Depression Inventory (BDI-II) and State-Trait Anxiety Inventory (STAI Y). [Time frame: 1 year]
• Interim evaluation of anxious and depressive symptoms with Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 Questionnaire (GAD-7), Beck's Depression Inventory (BDI-II) and State-Trait Anxiety Inventory (STAI Y). [Time frame: 6 months]

Secondary outcome measures (7)

• Evaluation of changes in psychological and psychopathological state dimensions from baseline to one year after bariatric surgery. [Time frame: 1 year]
• Interim evaluations of changes in other psychological and psychopathological state dimensions at six months after bariatric surgery. [Time frame: 6 months]
• Evaluation of the variation in global functioning levels from baseline to six months after bariatric. [Time frame: 6 months]
• Evaluation of the variation in global functioning levels at one year after bariatric surgery. [Time frame: one year]
• Evaluation of the variation of the quality of life at six months after bariatric surgery with Short Form Health Survey - 36 (SF-36). [Time frame: six months]
• Evaluation of the variation of the quality from baseline to one year after bariatric surgery with Short Form Health Survey - 36 (SF-36). [Time frame: 1 year]
• Identification of correlation between psychological and psychopathological trait dimensions and metabolic and inflammatory correlates. [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Endocrina e Metabolic — Roma

Identifiers

NCT: NCT06556459 · 6678

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗