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NCT Number: NCT05341414

Trajectories of Resilience and Bariatric Surgery Outcomes

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.

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Key information

Conditions

Severe Obesity Bariatric Surgery Candidate Body Weight Feeding and Eating Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Psychological Distress Signs and Symptoms Signs and Symptoms, Digestive Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalo-universitaire régional de Nancy

Vandœuvre-lès-Nancy, 54511, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Resilience (Questionnaire) : Resilience Scale for Adult (RSA)

    Time frame: baseline (T0)

    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

  2. Resilience (semi-structured interview) : level of resilience

    Time frame: baseline (T0)

    Categories : Non-resilient, intermediate, resilient Number and % of patients in each category

  3. Resilience (Questionnaire) : Resilience Scale for Adult (RSA)

    Time frame: 10 months (T1)

    Min: 33 ; Max: 231; Higher scores mean a better outcome

  4. Resilience (semi-structured interview) : level of resilience

    Time frame: 10 months (T1)

    Categories : Non-resilient, intermediate, resilient Number and % of patients in each category

  5. Resilience (Questionnaire) : Resilience Scale for Adult (RSA)

    Time frame: 2 years after surgery (T2)

    Min: 33 ; Max: 231; Higher scores mean a better outcome.

  6. Resilience (semi-structured interview) : level of resilience

    Time frame: 2 years after surgery (T2)

    Categories : Non-resilient, intermediate, resilient Number and % of patients in each category

Secondary outcomes

  1. Hospital Anxiety and Depression scale (HAD)

    Time frame: baseline (T0)

    Min: 0 ; Max: 42; Higher scores mean a worse outcome.

  2. Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: baseline (T0)

    Min: 33 ; Max: 165 ; Higher scores mean a worse outcome

  3. Binge eating scale (BES)

    Time frame: baseline (T0)

    Min: 0 ; Max: 48 ; Higher scores mean a worse outcome.

  4. Mini International Neuropsychiatric Interview (semi-structured interview)

    Time frame: baseline (T0)

    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).

  5. Psychological trauma (semi-structured interview)

    Time frame: Baseline (T0)

    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)

  6. Childhood Trauma Questionnaire (CTQ)

    Time frame: baseline (T0)

    Min: 25 ; Max: 125 ; Higher scores mean a worse outcome

  7. Toronto Alexithymia Scale (TAS)

    Time frame: baseline (T0)

    Min: 20 ; Max: 100 ; Higher scores mean a worse outcome

  8. Medical Outcomes Study Short Form (SF-36)

    Time frame: baseline (T0)

    Min: 0 ; Max: 100 ; Higher scores mean a better outcome.

  9. Definition of patient's psychological profile : clinical interviews

    Time frame: baseline (T0)

    Profile is determined by clinical interviews

  10. Definition of patient's psychological profile : Rorschach test

    Time frame: baseline (T0)

    Profile is determined by Rorschach test

  11. Characteristics of psychotherapy : Duration

    Time frame: baseline (T0)

    Duration of psychotherapy (month)

  12. Characteristics of psychotherapy : Frequency

    Time frame: baseline (T0)

    Frequency of psychotherapy (number of sessions per month)

  13. Characteristics of psychotherapy: Type of professional

    Time frame: baseline (T0)

    Type of professional (Psychiatrist, Psychologist, Nurse, Other)

  14. Characteristics of psychotherapy : Investment

    Time frame: baseline (T0)

    Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome.

  15. Sex

    Time frame: baseline (T0)

    men/women

  16. Age

    Time frame: baseline (T0)

    years

  17. Professional situation

    Time frame: baseline (T0)

    Active / Unemployed / Homemaker / Retired / Unable to work

  18. Family situation

    Time frame: baseline (T0)

    Currently married/cohabiting / Formerly married / Never married

  19. Weight data

    Time frame: baseline (T0)

    Weight: kg BMI: kg/m²

  20. Hospital Anxiety and Depression scale (HAD)

    Time frame: 10 months (T1)

    Min: 0 ; Max: 42; Higher scores mean a worse outcome

  21. Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: 10 months (T1)

    Min: 33 ; Max: 165 ; Higher scores mean a worse outcome

  22. Binge eating scale (BES)

    Time frame: 10 months (T1)

    Min: 0 ; Max: 48 ; Higher scores mean a worse outcome

  23. Mini International Neuropsychiatric Interview

    Time frame: 10 months (T1)

    • 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).

  24. Toronto Alexithymia Scale (TAS)

    Time frame: 10 months (T1)

    Min: 20 ; Max: 100 ; Higher scores mean a worse outcome.

  25. Medical Outcomes Study Short Form (SF-36)

    Time frame: 10 months (T1)

    Min: 0 ; Max: 100 ; Higher scores mean a better outcome.

  26. Definition of patient's psychological profile :clinical interviews

    Time frame: 10 months (T1)

    Profile is determined by clinical interviews

  27. Definition of patient's psychological profile : Rorschach test

    Time frame: 10 months (T1)

    Profile is determined by Rorschach test

  28. Characteristics of psychotherapy: Duration

    Time frame: 10 months (T1)

    Duration of psychotherapy (month)

  29. Characteristics of psychotherapy: Frequency

    Time frame: 10 months (T1)

    Frequency of psychotherapy (number of sessions per month)

  30. Characteristics of psychotherapy: Type of professional

    Time frame: 10 months (T1)

    Type of professional (Psychiatrist, Psychologist, Nurse, Other)

  31. Characteristics of psychotherapy: Investment

    Time frame: 10 months (T1)

    Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome.

  32. Professional situation

    Time frame: 10 months (T1)

    Active / Unemployed / Homemaker / Retired / Unable to work

  33. Family situation

    Time frame: 10 months (T1)

    Currently married/cohabiting / Formerly married / Never married

  34. Weight data

    Time frame: 10 months (T1)

    Weight: kg BMI: kg/m²

  35. Hospital Anxiety and Depression scale (HAD)

    Time frame: 2 years after surgery (T2)

    Min: 0 ; Max: 42; Higher scores mean a worse outcome.

  36. Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: 2 years after surgery (T2)

    Min: 33 ; Max: 165 ; Higher scores mean a worse outcome.

  37. Binge eating scale (BES)

    Time frame: 2 years after surgery (T2)

    Min: 0 ; Max: 48 ; Higher scores mean a worse outcome.

  38. Mini International Neuropsychiatric Interview

    Time frame: 2 years after surgery (T2)

    • 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).

  39. Toronto Alexithymia Scale (TAS)

    Time frame: 2 years after surgery (T2)

    Min: 20 ; Max: 100 ; Higher scores mean a worse outcome.

  40. Medical Outcomes Study Short Form (SF-36)

    Time frame: 2 years after surgery (T2)

    Min: 0 ; Max: 100 ; Higher scores mean a better outcome.

  41. Definition of patient's psychological profile : clinical interviews

    Time frame: 2 years after surgery (T2)

    Profile is determined by clinical interviews

  42. Definition of patient's psychological profile : Rorschach test

    Time frame: 2 years after surgery (T2)

    Profile is determined by Rorschach test

  43. Characteristics of psychotherapy: Duration

    Time frame: 2 years after surgery (T2)

    Duration of psychotherapy (month)

  44. Characteristics of psychotherapy: Frequency

    Time frame: 2 years after surgery (T2)

    Frequency of psychotherapy (number of sessions per month)

  45. Characteristics of psychotherapy: Type of professional

    Time frame: 2 years after surgery (T2)

    Type of professional (Psychiatrist, Psychologist, Nurse, Other)

  46. Characteristics of psychotherapy: Investment

    Time frame: 2 years after surgery (T2)

    Investment in psychotherapy (0:bad ; 5: excellent) Min: 0 ; Max: 5 ; Higher scores mean a better outcome.

  47. Professional situation

    Time frame: 2 years after surgery (T2)

    Active / Unemployed / Homemaker / Retired / Unable to work

  48. Family situation

    Time frame: 2 years after surgery (T2)

    Currently married/cohabiting / Formerly married / Never married

  49. Weight data

    Time frame: 2 years after surgery (T2)

    Weight: kg BMI: kg/m²

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ECLAIRCIE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

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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