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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05341414
Other study ID # 2020PI203
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2021
Est. completion date December 15, 2021

Study information

Verified date April 2022
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A high prevalence of psychological trauma on one hand and of psychiatric disorders, such as depression, anxiety, suicide attempts, addictions, and eating disorders on the other hand, has been reported in patients with severe obesity seeking bariatric surgery. Some studies reported an increased prevalence of these psychiatric disorders after bariatric surgery, potentially related to weight regain. In this context, psychological resilience is a concept that brings together internal and external factors of adaptation, and whose clinical use facilitates interdisciplinary collaborative work. This research focuses on the association between resilience and success or failure of bariatric surgery in patients followed in the Specialized Obesity Center (CSO) of the Nancy University Hospital. The hypothesis is that psychological resilience before surgery promotes successful surgical treatment. This retrospective study is based on existing data from patients with severe obesity who have undergone bariatric surgery at the Nancy CSO. The main objective is to study 1) the resilience of patients with severe obesity, candidates for bariatric surgery, at the first assessment (T0), at the end of lifestyle/behavioral modifications program (T1) and at 2 years after bariatric surgery (T2), 2) the relationship between internal and external factors explaining resilience and final weight outcomes. The investigators are expected that non-resilient patients have more psychological vulnerabilities (psychopathology, negative life events, etc.), and have lower weight loss than resilient patients.


Description:

The investigators will report the change of resilience during lifestyle/behavioral modifications program and 2 years after bariatric surgical treatment, and the investigators will describe the factors associated with this change: - History of trauma - Psychopathology (eating disorders, depression, anxiety, addiction) - Personality factors - Characteristic of psychotherapy


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Severe obesity (BMI =35 kg/m2) - Candidate for Bariatric surgery at Nancy CSO (2016-2020) after a lifestyle/behavioral modifications program - Full psychological assessment data Exclusion Criteria: - Patient's opposition to the use of data for research purposes

Study Design


Locations

Country Name City State
France Centre hospitalo-universitaire régional de Nancy Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resilience (Questionnaire) : Resilience Scale for Adult (RSA) Min: 33 ; Max: 231; Higher scores mean a better outcome Score of resilience (Resilience Scale for adults) and level of resilience (non-resilient, intermediate, resilient) / number of patients in each category baseline (T0)
Primary Resilience (semi-structured interview) : level of resilience Categories : Non-resilient, intermediate, resilient Number and % of patients in each category baseline (T0)
Primary Resilience (Questionnaire) : Resilience Scale for Adult (RSA) Min: 33 ; Max: 231; Higher scores mean a better outcome 10 months (T1)
Primary Resilience (semi-structured interview) : level of resilience Categories : Non-resilient, intermediate, resilient Number and % of patients in each category 10 months (T1)
Primary Resilience (Questionnaire) : Resilience Scale for Adult (RSA) Min: 33 ; Max: 231; Higher scores mean a better outcome. 2 years after surgery (T2)
Primary Resilience (semi-structured interview) : level of resilience Categories : Non-resilient, intermediate, resilient Number and % of patients in each category 2 years after surgery (T2)
Secondary Hospital Anxiety and Depression scale (HAD) Min: 0 ; Max: 42; Higher scores mean a worse outcome. baseline (T0)
Secondary Dutch Eating Behaviour Questionnaire (DEBQ) Min: 33 ; Max: 165 ; Higher scores mean a worse outcome baseline (T0)
Secondary Binge eating scale (BES) Min: 0 ; Max: 48 ; Higher scores mean a worse outcome. baseline (T0)
Secondary Mini International Neuropsychiatric Interview (semi-structured interview) Number and % of patients in each category (major depressive episode, dysthymia, suicidal risk, bipolar disorder, panic disorder, agoraphobia, social phobia, obsessive compulsive disorder, post-traumatic stress disorders, alcohol (addiction/abuse), drugs (addiction/abuse), psychotic disorders, generalized anxiety, anti- social personality disorders, eating disorders). baseline (T0)
Secondary Psychological trauma (semi-structured interview) Number and % of patients in each category (Sexual, physical, emotional abuse, emotional and physical neglect) Number and % of patients in each category for the first trauma (childhood, adolescence, adulthood) Baseline (T0)
Secondary Childhood Trauma Questionnaire (CTQ) Min: 25 ; Max: 125 ; Higher scores mean a worse outcome baseline (T0)
Secondary Toronto Alexithymia Scale (TAS) Min: 20 ; Max: 100 ; Higher scores mean a worse outcome baseline (T0)
Secondary Medical Outcomes Study Short Form (SF-36) Min: 0 ; Max: 100 ; Higher scores mean a better outcome. baseline (T0)
Secondary Definition of patient's psychological profile : clinical interviews Profile is determined by clinical interviews baseline (T0)
Secondary Definition of patient's psychological profile : Rorschach test Profile is determined by Rorschach test baseline (T0)
Secondary Characteristics of psychotherapy : Duration Duration of psychotherapy (month) baseline (T0)
Secondary Characteristics of psychotherapy : Frequency Frequency of psychotherapy (number of sessions per month) baseline (T0)
Secondary Characteristics of psychotherapy: Type of professional Type of professional (Psychiatrist, Psychologist, Nurse, Other) baseline (T0)
Secondary Characteristics of psychotherapy : Investment Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome. baseline (T0)
Secondary Sex men/women baseline (T0)
Secondary Age years baseline (T0)
Secondary Professional situation Active / Unemployed / Homemaker / Retired / Unable to work baseline (T0)
Secondary Family situation Currently married/cohabiting / Formerly married / Never married baseline (T0)
Secondary Weight data Weight: kg BMI: kg/m² baseline (T0)
Secondary Hospital Anxiety and Depression scale (HAD) Min: 0 ; Max: 42; Higher scores mean a worse outcome 10 months (T1)
Secondary Dutch Eating Behaviour Questionnaire (DEBQ) Min: 33 ; Max: 165 ; Higher scores mean a worse outcome 10 months (T1)
Secondary Binge eating scale (BES) Min: 0 ; Max: 48 ; Higher scores mean a worse outcome 10 months (T1)
Secondary Mini International Neuropsychiatric Interview • Number and % of patients in each category (major depressive episode, dysthymia, suicidal risk, bipolar disorder, panic disorder, agoraphobia, social phobia, obsessive compulsive disorder, post-traumatic stress disorders, alcohol (addiction/abuse), drugs (addiction/abuse), psychotic disorders, generalized anxiety, anti- social personality disorders, eating disorders). 10 months (T1)
Secondary Toronto Alexithymia Scale (TAS) Min: 20 ; Max: 100 ; Higher scores mean a worse outcome. 10 months (T1)
Secondary Medical Outcomes Study Short Form (SF-36) Min: 0 ; Max: 100 ; Higher scores mean a better outcome. 10 months (T1)
Secondary Definition of patient's psychological profile :clinical interviews Profile is determined by clinical interviews 10 months (T1)
Secondary Definition of patient's psychological profile : Rorschach test Profile is determined by Rorschach test 10 months (T1)
Secondary Characteristics of psychotherapy: Duration Duration of psychotherapy (month) 10 months (T1)
Secondary Characteristics of psychotherapy: Frequency Frequency of psychotherapy (number of sessions per month) 10 months (T1)
Secondary Characteristics of psychotherapy: Type of professional Type of professional (Psychiatrist, Psychologist, Nurse, Other) 10 months (T1)
Secondary Characteristics of psychotherapy: Investment Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome. 10 months (T1)
Secondary Professional situation Active / Unemployed / Homemaker / Retired / Unable to work 10 months (T1)
Secondary Family situation Currently married/cohabiting / Formerly married / Never married 10 months (T1)
Secondary Weight data Weight: kg BMI: kg/m² 10 months (T1)
Secondary Hospital Anxiety and Depression scale (HAD) Min: 0 ; Max: 42; Higher scores mean a worse outcome. 2 years after surgery (T2)
Secondary Dutch Eating Behaviour Questionnaire (DEBQ) Min: 33 ; Max: 165 ; Higher scores mean a worse outcome. 2 years after surgery (T2)
Secondary Binge eating scale (BES) Min: 0 ; Max: 48 ; Higher scores mean a worse outcome. 2 years after surgery (T2)
Secondary Mini International Neuropsychiatric Interview • Number and % of patients in each category (major depressive episode, dysthymia, suicidal risk, bipolar disorder, panic disorder, agoraphobia, social phobia, obsessive compulsive disorder, post-traumatic stress disorders, alcohol (addiction/abuse), drugs (addiction/abuse), psychotic disorders, generalized anxiety, anti- social personality disorders, eating disorders). 2 years after surgery (T2)
Secondary Toronto Alexithymia Scale (TAS) Min: 20 ; Max: 100 ; Higher scores mean a worse outcome. 2 years after surgery (T2)
Secondary Medical Outcomes Study Short Form (SF-36) Min: 0 ; Max: 100 ; Higher scores mean a better outcome. 2 years after surgery (T2)
Secondary Definition of patient's psychological profile : clinical interviews Profile is determined by clinical interviews 2 years after surgery (T2)
Secondary Definition of patient's psychological profile : Rorschach test Profile is determined by Rorschach test 2 years after surgery (T2)
Secondary Characteristics of psychotherapy: Duration Duration of psychotherapy (month) 2 years after surgery (T2)
Secondary Characteristics of psychotherapy: Frequency Frequency of psychotherapy (number of sessions per month) 2 years after surgery (T2)
Secondary Characteristics of psychotherapy: Type of professional Type of professional (Psychiatrist, Psychologist, Nurse, Other) 2 years after surgery (T2)
Secondary Characteristics of psychotherapy: Investment Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome. 2 years after surgery (T2)
Secondary Professional situation Active / Unemployed / Homemaker / Retired / Unable to work 2 years after surgery (T2)
Secondary Family situation Currently married/cohabiting / Formerly married / Never married 2 years after surgery (T2)
Secondary Weight data Weight: kg BMI: kg/m² 2 years after surgery (T2)
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