ObesityPSICOBARNCT06556459
Psychological and Psychopathological Characteristics of Patients With Obesity Candidates for Bariatric Surgery
An observational study of Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with diagnosis of grade II or grade III (or pathological) obesity based on body mass index values, respectively, of 35-40 and >40 kg/m² who access the Policlinico to apply for bariatric surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Endocrina e Metabolica
Roma, 00168
Marco Raffaelli, +0630156194, marco.raffaelli@policlinicogemelli.it
Maria Rosaria Magurano, mariarosaria.magurano@policlinicogemelli.it
About this study
Official title: Psychological and Psychopathological Characteristics of Patients With Severe or Pathological 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
Read more
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
- Being tested
- Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or surgery
The patient performs:
- psychological clinical interview
- psychodiagnostic examination
- internal medical examination
- blood tests
- electrocardiogram
- bariatric surgery
- surgical visit
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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
Measured: 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).
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
Measured: 6 months
Secondary outcomes (7)
Evaluation of changes in psychological and psychopathological state dimensions from baseline to one year after bariatric surgery.
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
Measured: 1 year
Interim evaluations of changes in other psychological and psychopathological state dimensions at six months after bariatric surgery.
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
Measured: 6 months
Evaluation of the variation in global functioning levels from baseline to six months after bariatric.
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.
Measured: 6 months
Evaluation of the variation in global functioning levels at one year after bariatric surgery.
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.
Measured: 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).
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).
Measured: 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).
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).
Measured: 1 year
Identification of correlation between psychological and psychopathological trait dimensions and metabolic and inflammatory correlates.
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);
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Raffaelli, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556459
- Sponsor's protocol ID
- 6678
- Acronym
- PSICOBAR
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Psychopathological Characteristics of Patients With Severe or Pathological Obesity Candidates for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06556459
- Acronym / sponsor ID
- PSICOBAR / 6678
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diagnosis of grade II or grade III (or pathological) obesity based on body mass index values, respectively, of 35-40 and >40 kg/m² who access the Policlinico to apply for bariatric surgery.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgeryThe patient performs: * psychological clinical interview * psychodiagnostic examination * internal medical examination * blood tests * electrocardiogram * bariatric surgery * surgical visit | Procedure or surgery | – |
Primary outcome
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
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Raffaelli principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Raffaelli (+390630156194, marco.raffaelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.