Clinical trial NCT05341414: Trajectories of Resilience and Bariatric Surgery Outcomes
Official title: Resilience Trajectories Following a Preoperative Lifestyle /Behavioral Modification Program and Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Obesity
Psychological Distress
Bariatric Surgery Candidate
Keywords: Severe obesity
Resilience
Trauma
Psychological disorders
Eating disorders
Bariatric surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seeking for bariatric surgery at the Nancy CSO

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Resilience (Questionnaire) : Resilience Scale for Adult (RSA)
timeFrame: baseline (T0)
measure: Resilience (semi-structured interview) : level of resilience
timeFrame: baseline (T0)
measure: Resilience (Questionnaire) : Resilience Scale for Adult (RSA)
timeFrame: 10 months (T1)
measure: Resilience (semi-structured interview) : level of resilience
timeFrame: 10 months (T1)
measure: Resilience (Questionnaire) : Resilience Scale for Adult (RSA)
timeFrame: 2 years after surgery (T2)
measure: Resilience (semi-structured interview) : level of resilience
timeFrame: 2 years after surgery (T2)
Secondary outcomes:
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: baseline (T0)
measure: Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: baseline (T0)
measure: Binge eating scale (BES)
timeFrame: baseline (T0)
measure: Mini International Neuropsychiatric Interview (semi-structured interview)
timeFrame: baseline (T0)
measure: Psychological trauma (semi-structured interview)
timeFrame: Baseline (T0)
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: baseline (T0)
measure: Toronto Alexithymia Scale (TAS)
timeFrame: baseline (T0)
measure: Medical Outcomes Study Short Form (SF-36)
timeFrame: baseline (T0)
measure: Definition of patient's psychological profile : clinical interviews
timeFrame: baseline (T0)
measure: Definition of patient's psychological profile : Rorschach test
timeFrame: baseline (T0)
measure: Characteristics of psychotherapy : Duration
timeFrame: baseline (T0)
measure: Characteristics of psychotherapy : Frequency
timeFrame: baseline (T0)
measure: Characteristics of psychotherapy: Type of professional
timeFrame: baseline (T0)
measure: Characteristics of psychotherapy : Investment
timeFrame: baseline (T0)
measure: Sex
timeFrame: baseline (T0)
measure: Age
timeFrame: baseline (T0)
measure: Professional situation
timeFrame: baseline (T0)
measure: Family situation
timeFrame: baseline (T0)
measure: Weight data
timeFrame: baseline (T0)
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: 10 months (T1)
measure: Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: 10 months (T1)
measure: Binge eating scale (BES)
timeFrame: 10 months (T1)
measure: Mini International Neuropsychiatric Interview
timeFrame: 10 months (T1)
measure: Toronto Alexithymia Scale (TAS)
timeFrame: 10 months (T1)
measure: Medical Outcomes Study Short Form (SF-36)
timeFrame: 10 months (T1)
measure: Definition of patient's psychological profile :clinical interviews
timeFrame: 10 months (T1)
measure: Definition of patient's psychological profile : Rorschach test
timeFrame: 10 months (T1)
measure: Characteristics of psychotherapy: Duration
timeFrame: 10 months (T1)
measure: Characteristics of psychotherapy: Frequency
timeFrame: 10 months (T1)
measure: Characteristics of psychotherapy: Type of professional
timeFrame: 10 months (T1)
measure: Characteristics of psychotherapy: Investment
timeFrame: 10 months (T1)
measure: Professional situation
timeFrame: 10 months (T1)
measure: Family situation
timeFrame: 10 months (T1)
measure: Weight data
timeFrame: 10 months (T1)
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: 2 years after surgery (T2)
measure: Dutch Eating Behaviour Questionnaire (DEBQ)
timeFrame: 2 years after surgery (T2)
measure: Binge eating scale (BES)
timeFrame: 2 years after surgery (T2)
measure: Mini International Neuropsychiatric Interview
timeFrame: 2 years after surgery (T2)
measure: Toronto Alexithymia Scale (TAS)
timeFrame: 2 years after surgery (T2)
measure: Medical Outcomes Study Short Form (SF-36)
timeFrame: 2 years after surgery (T2)
measure: Definition of patient's psychological profile : clinical interviews
timeFrame: 2 years after surgery (T2)
measure: Definition of patient's psychological profile : Rorschach test
timeFrame: 2 years after surgery (T2)
measure: Characteristics of psychotherapy: Duration
timeFrame: 2 years after surgery (T2)
measure: Characteristics of psychotherapy: Frequency
timeFrame: 2 years after surgery (T2)
measure: Characteristics of psychotherapy: Type of professional
timeFrame: 2 years after surgery (T2)
measure: Characteristics of psychotherapy: Investment
timeFrame: 2 years after surgery (T2)
measure: Professional situation
timeFrame: 2 years after surgery (T2)
measure: Family situation
timeFrame: 2 years after surgery (T2)
measure: Weight data
timeFrame: 2 years after surgery (T2)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Centre hospitalo-universitaire régional de Nancy
Study officials:
affiliation: CHRU -Nancy, Université de Lorraine
name: Olivier Ziegler, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: