Trajectories of Resilience and Bariatric Surgery Outcomes

Bariatric Surgery Candidate Clinical Trial

— ECLAIRCIE  

Official title:

Resilience Trajectories Following a Preoperative Lifestyle /Behavioral Modification Program and Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341414
• Other study ID #: 2020PI203
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid
• Psychological Distress
• Severe Obesity

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)