Longitudinal Study of the Psychological Impact of Bariatric Surgery

NCT07780058 | Recruiting

• 1 other identifier: B/2025/15
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective observational study evaluates the effect of bariatric surgery on mental health and hair cortisol in patients with morbid obesity over a 3-year follow-up. Assessments will be performed before surgery and at 1 month, 1 year, 2 years, and 3 years to analyze psychological changes, weight changes, and the need for psychological support.

Conditions

Obesity

Keywords

psychological well-being; bariatric surgery; hair cortisol; morbid obesity; follow-up

Outcome Measures

Primary Outcomes (1)

• Global Severity Index (GSI) score of the Symptom Checklist-90-Revised (SCL-90-R)

  Change in overall psychological distress assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R).

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

Secondary Outcomes (11)

• Perceived Stress Scale (PSS-14) score

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

• UPPS-P Short Version score

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

• Hair cortisol concentration

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

• Moorehead-Ardelt Quality of Life Questionnaire II score

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

• Eating Disorder Examination Questionnaire (EDE-Q) score

  Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.

Study Arms (1)

Bariatric Surgery Group

Patients with severe obesity who are candidates for bariatric surgery.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with morbid obesity who are candidates for bariatric surgery and will be treated and followed at the participating hospital/center.

You may qualify if:

• Men and women aged 18 to 70 years who are candidates for gastric bypass, sleeve gastrectomy, or single-anastomosis duodeno-ileal bypass (SADI-S), with a body mass index of at least 40 kg/m² or at least 35 kg/m² with comorbidities, and who are able to provide informed consent.

You may not qualify if:

• Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.

Sponsors & Collaborators

• University of Alicante: lead
• Instituto de Investigación Sanitaria y Biomédica de Alicante: collaborator
• FISABIO (Foundation for the Promotion of Healthcare and Biomedical Research in the Valencian Community): collaborator

Study Sites (2)

Hospital Universitario Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Alicante, 03010, Spain

RECRUITING

Related Publications (4)

• Sarwer DB, Wadden TA, Ashare R, Spitzer JC, McCuen-Wurst C, LaGrotte C, Williams N, Soans R, Tewksbury C, Wu J, Tajeu G, Allison KC. Psychopathology, disordered eating, and impulsivity as predictors of weight loss 24 months after metabolic and bariatric surgery. Surg Obes Relat Dis. 2024 Jul;20(7):634-642. doi: 10.1016/j.soard.2024.01.019. Epub 2024 Feb 7.

  PMID: 38480031 BACKGROUND

• van Reekum EA, Darcy M, Drage J, Xu J, Ng K, Forestell B, Santesso N, Joundi RA, Wong J, Doumouras A, Taylor VH, Yusuf S, Van Lieshout R. Psychiatric and Cognitive Functioning After Metabolic and Bariatric Surgery: A Systematic Review and Meta-Analysis. Obes Rev. 2025 Nov;26(11):e13968. doi: 10.1111/obr.13968. Epub 2025 Jun 22.

  PMID: 40545266 BACKGROUND

• Martinez Gonzalez A, Gonzalez Nunes M, Pena Pineiro N, Argibay Ulloa M, Fraile Amador FJ, Llopiz Castedo J, Jaimes Jaimes SM, Rodriguez Pulian J, Rodriguez Castineira TC, Silva Sousa JI, Sieiro Pena CE, Gonzalez Valladares MG. [Long-term effectiveness of bariatric surgery: weight and metabolic outcomes after 10 years of follow-up]. Nutr Hosp. 2025 Sep 4;42(4):686-694. doi: 10.20960/nh.05876. Spanish.

  PMID: 40576229 BACKGROUND

• Budin AJ, Brown WA, MacCormick AD, Caterson I, Sumithran P. Depressive symptoms at short-, medium-, and long-term follow-up after bariatric surgical procedures: A systematic review and meta-analysis. Obes Rev. 2025 Aug;26(8):e13927. doi: 10.1111/obr.13927. Epub 2025 Apr 13.

  PMID: 40222815 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair sample collection for cortisol analysis.

MeSH Terms

Conditions

Obesity; Psychological Well-Being; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Cristian Marco, MD, PhD

  Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  STUDY DIRECTOR

• Rahma Amrani, MSc

  Instituto de Investigación Sanitaria y Biomédica de Alicante

  STUDY CHAIR

• Nieves Pérez, MD

  Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  STUDY CHAIR

• Trinidad M Castillo, MSc

  Instituto de Investigación Sanitaria y Biomédica de Alicante

  STUDY CHAIR

• Ángel L Abad, MD

  Instituto de Investigación Sanitaria y Biomédica de Alicante

  STUDY CHAIR

• Myriam Sánchez, MD

  Instituto de Investigación Sanitaria y Biomédica de Alicante

  STUDY CHAIR

• Dolores M Fernández, PhD

  Instituto de Investigación Sanitaria y Biomédica de Alicante

  STUDY CHAIR

Central Study Contacts

Lorena Andreu Lucena, MSc

CONTACT

+34667508676; lorenapsicologiabariatrica@gmail.com

Ana M Santos, PhD

CONTACT

+34 965 90 3960; anasantos@gcloud.ua.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 21, 2026
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 28, 2028
• Study Completion (Estimated): October 28, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)