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NCT Number: NCT06556459

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Roma, 00168, Italy

Location contact

Marco Raffaelli

CONTACT

[email protected]

+0630156194

Marco Raffaelli

PRINCIPAL_INVESTIGATOR

Maria Rosaria Magurano

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

The patient performs:

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

Primary outcomes

  1. 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

    Evaluation of changes in anxiety and depressive symptoms from baseline to one year after bariatric surgery 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).

    GAD - 7:

    0 - 4: minimal 5 - 9: mild 10 - 14: moderate 15 - 21: severe

    PHQ - 9:

    0 - 4: minimal 5 - 9: mild 10 - 14: moderate 15 - 19: moderately severe 20 - 27: severe

    BDI-II:

    < 7: none 8 - 17: mild 18 - 24: moderate >25: severe

    STAI-Y1/Y2:

    20 - 37: none or minimal 38 - 44: moderate 45 - 80: severe

  2. 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

    Interim evaluation of anxiety and depressive symptoms at six months after bariatric surgery 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).

    GAD - 7:

    0 - 4: minimal 5 - 9: mild 10 - 14: moderate 15 - 21: severe

    PHQ - 9:

    0 - 4: minimal 5 - 9: mild 10 - 14: moderate 15 - 19: moderately severe 20 - 27: severe

    BDI-II:

    < 7: none 8 - 17: mild 18 - 24: moderate >25: severe

    STAI-Y1/Y2:

    20 - 37: none or minimal 38 - 44: moderate 45 - 80: severe

Secondary outcomes

  1. Evaluation of changes in psychological and psychopathological state dimensions from baseline to one year after bariatric surgery.

    Time frame: 1 year

    Evaluation of changes in other psychological and psychopathological state dimensions from baseline to one year after bariatric surgery with Short Form Health Survey - 36 (SF-36), Perceived Stress Scale (PSS), Eating Disorder Examination Questionnaire (EDE-Q 6), Binge Eating Scale (BES), Clinical Impairment Assessment Questionnaire (CIA 3.0), Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM).

    SF-36:

    The score ranges from 0 (negative health) to 100 (positive health).

    PSS:

    0-13: low stress 14-26: moderate stress 27-60: high perceived stress

    EDE-Q 6:

    > 2,8: clinically significant

    BES:

    <17: improbable 17-27: possible >27: possible

    CIA 3.0:

    The resulting scores range from 0 to 48, where a higher score indicates a higher level of secondary psychosocial impairment.

    CORE-OM:

    <0,6: healthy 0,6-1: low 1-1,5: mild 1,5-2: moderate 2-2,5: moderately severe >2,5: severe

  2. Interim evaluations of changes in other psychological and psychopathological state dimensions at six months after bariatric surgery.

    Time frame: 6 months

    Interim evaluations after six months of changes in other psychological and psychopathological state dimensions as per clinical practice.

    It will be used Short Form Health Survey - 36 (SF-36), Perceived Stress Scale (PSS), Eating Disorder Examination Questionnaire (EDE-Q 6), Binge Eating Scale (BES), Clinical Impairment Assessment Questionnaire (CIA 3.0), Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM).

    SF-36:

    The score ranges from 0 (negative health) to 100 (positive health).

    PSS:

    0-13: low stress 14-26: moderate stress 27-60: high perceived stress

    EDE-Q 6:

    > 2,8: clinically significant

    BES:

    <17: improbable 17-27: possible >27: possible

    CIA 3.0:

    The resulting scores range from 0 to 48, where a higher score indicates a higher level of secondary psychosocial impairment.

    CORE-OM:

    <0,6: healthy 0,6-1: low 1-1,5: mild 1,5-2: moderate 2-2,5: moderately severe >2,5: severe

  3. 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 from baseline at six months after bariatric surgery with Difficulties in Emotion Regulation Scale (DERS), Barratt Impulsiveness Scale (BIS 11), Connor-Davidson Resilience Scale (CD-RISC) and Childhood Trauma Questionnaire (CTQ-SF).

    DERS:

    Higher scores suggest greater problems with emotion regulation

    BIS-11:

    30-49: low 50-69: mild 70-89: severe 90-120: extremely severe

    CD-RISC:

    A higher score indicates a higher level of resilience

    CTQ-SF:

    This questionnaire measures five types of abuse. For each type of childhood trauma, the higher the score is, the greater the severity of abuse for that scale.

  4. Evaluation of the variation in global functioning levels at one year after bariatric surgery.

    Time frame: one year

    Evaluation of the variation in global functioning levels from baseline at one year after bariatric surgery with Difficulties in Emotion Regulation Scale (DERS), Barratt Impulsiveness Scale (BIS 11), Connor-Davidson Resilience Scale (CD-RISC) and Childhood Trauma Questionnaire (CTQ-SF).

    DERS:

    Higher scores suggest greater problems with emotion regulation

    BIS-11:

    30-49: low 50-69: mild 70-89: severe 90-120: extremely severe

    CD-RISC:

    A higher score indicates a higher level of resilience

    CTQ-SF:

    This questionnaire measures five types of abuse. For each type of childhood trauma, the higher the score is, the greater the severity of abuse for that scale.

  5. 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 of life at six months after bariatric surgery with Short Form Health Survey - 36 (SF-36).

    SF-36:

    The score ranges from 0 (negative health) to 100 (positive health).

  6. 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

    Evaluation of the variation of the quality from baseline to one year after bariatric surgery with Short Form Health Survey - 36 (SF-36).

    SF-36:

    The score ranges from 0 (negative health) to 100 (positive health).

  7. Identification of correlation between psychological and psychopathological trait dimensions and metabolic and inflammatory correlates.

    Time frame: 1 year

    Identification of correlation between psychological and psychopathological trait dimensions and metabolic and inflammatory correlates that predict response to bariatric surgery interventions.

    It will be measured the variation of the metabolic and inflammatory correlates from baseline to one year after bariatric surgery.

    It will be considered: complete blood count with leukocyte count; C-reactive Protein (PCR); Erythrocyte sedimentation rate (VES); fibrinogen; magnesium; calcium; phosphorus; parathyroid hormone (PTH); vitamin D; uric acid; carbohydrate and lipid profile (glucose, total and HDL cholesterol, triglycerides);

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Raffaelli

CONTACT

[email protected]

+390630156194

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: PSICOBAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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