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Severe ObesityECLAIRCIENCT05341414

Trajectories of Resilience and Bariatric Surgery Outcomes

An observational study of Severe Obesity and Psychological Distress, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 siteFrance
Study dates
3 May 2021to 15 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients seeking for bariatric surgery at the Nancy CSO

Who may be able to join

  • 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

Who cannot join

  • Patient's opposition to the use of data for research purposes

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre hospitalo-universitaire régional de Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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

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.

Read the 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
Keywords
Severe obesity, Resilience, Trauma, Psychological disorders, Eating disorders, Bariatric surgery
Medical subject headings
Obesity, Morbid, Wounds and Injuries, Mental Disorders, Feeding and Eating Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline (T0)

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

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

    Measured: baseline (T0)

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

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

    Measured: 10 months (T1)

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

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

    Measured: 10 months (T1)

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

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

    Measured: 2 years after surgery (T2)

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

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

    Measured: 2 years after surgery (T2)

Secondary outcomes (49)

  1. Hospital Anxiety and Depression scale (HAD)

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

    Measured: baseline (T0)

  2. Dutch Eating Behaviour Questionnaire (DEBQ)

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

    Measured: baseline (T0)

  3. Binge eating scale (BES)

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

    Measured: baseline (T0)

  4. 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).

    Measured: baseline (T0)

  5. 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)

    Measured: Baseline (T0)

  6. Childhood Trauma Questionnaire (CTQ)

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

    Measured: baseline (T0)

  7. Toronto Alexithymia Scale (TAS)

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

    Measured: baseline (T0)

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

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

    Measured: baseline (T0)

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

    Profile is determined by clinical interviews

    Measured: baseline (T0)

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

    Profile is determined by Rorschach test

    Measured: baseline (T0)

  11. Characteristics of psychotherapy : Duration

    Duration of psychotherapy (month)

    Measured: baseline (T0)

  12. Characteristics of psychotherapy : Frequency

    Frequency of psychotherapy (number of sessions per month)

    Measured: baseline (T0)

  13. Characteristics of psychotherapy: Type of professional

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

    Measured: baseline (T0)

  14. Characteristics of psychotherapy : Investment

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

    Measured: baseline (T0)

  15. Sex

    men/women

    Measured: baseline (T0)

  16. Age

    years

    Measured: baseline (T0)

  17. Professional situation

    Active / Unemployed / Homemaker / Retired / Unable to work

    Measured: baseline (T0)

  18. Family situation

    Currently married/cohabiting / Formerly married / Never married

    Measured: baseline (T0)

  19. Weight data

    Weight: kg BMI: kg/m²

    Measured: baseline (T0)

  20. Hospital Anxiety and Depression scale (HAD)

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

    Measured: 10 months (T1)

  21. Dutch Eating Behaviour Questionnaire (DEBQ)

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

    Measured: 10 months (T1)

  22. Binge eating scale (BES)

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

    Measured: 10 months (T1)

  23. 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).

    Measured: 10 months (T1)

  24. Toronto Alexithymia Scale (TAS)

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

    Measured: 10 months (T1)

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

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

    Measured: 10 months (T1)

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

    Profile is determined by clinical interviews

    Measured: 10 months (T1)

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

    Profile is determined by Rorschach test

    Measured: 10 months (T1)

  28. Characteristics of psychotherapy: Duration

    Duration of psychotherapy (month)

    Measured: 10 months (T1)

  29. Characteristics of psychotherapy: Frequency

    Frequency of psychotherapy (number of sessions per month)

    Measured: 10 months (T1)

  30. Characteristics of psychotherapy: Type of professional

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

    Measured: 10 months (T1)

  31. Characteristics of psychotherapy: Investment

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

    Measured: 10 months (T1)

  32. Professional situation

    Active / Unemployed / Homemaker / Retired / Unable to work

    Measured: 10 months (T1)

  33. Family situation

    Currently married/cohabiting / Formerly married / Never married

    Measured: 10 months (T1)

  34. Weight data

    Weight: kg BMI: kg/m²

    Measured: 10 months (T1)

  35. Hospital Anxiety and Depression scale (HAD)

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

    Measured: 2 years after surgery (T2)

  36. Dutch Eating Behaviour Questionnaire (DEBQ)

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

    Measured: 2 years after surgery (T2)

  37. Binge eating scale (BES)

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

    Measured: 2 years after surgery (T2)

  38. 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).

    Measured: 2 years after surgery (T2)

  39. Toronto Alexithymia Scale (TAS)

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

    Measured: 2 years after surgery (T2)

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

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

    Measured: 2 years after surgery (T2)

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

    Profile is determined by clinical interviews

    Measured: 2 years after surgery (T2)

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

    Profile is determined by Rorschach test

    Measured: 2 years after surgery (T2)

  43. Characteristics of psychotherapy: Duration

    Duration of psychotherapy (month)

    Measured: 2 years after surgery (T2)

  44. Characteristics of psychotherapy: Frequency

    Frequency of psychotherapy (number of sessions per month)

    Measured: 2 years after surgery (T2)

  45. Characteristics of psychotherapy: Type of professional

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

    Measured: 2 years after surgery (T2)

  46. Characteristics of psychotherapy: Investment

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

    Measured: 2 years after surgery (T2)

  47. Professional situation

    Active / Unemployed / Homemaker / Retired / Unable to work

    Measured: 2 years after surgery (T2)

  48. Family situation

    Currently married/cohabiting / Formerly married / Never married

    Measured: 2 years after surgery (T2)

  49. Weight data

    Weight: kg BMI: kg/m²

    Measured: 2 years after surgery (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start3 May 2021
  3. Primary completion15 Oct 2021
  4. Study completion15 Dec 2021

Resources

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
Retrospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05341414
Sponsor's protocol ID
2020PI203
Acronym
ECLAIRCIE
Status last verified
Apr 2022
First submitted
21 Mar 2022
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Obesity and Psychological Distress, run by Central Hospital, Nancy, France at 1 site in France.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2022. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resilience (Questionnaire) : Resilience Scale for Adult (RSA) (time frame: baseline (T0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05341414.

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 22 Apr 2022.

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