Psychological prehabilitation for complex GI surgery
Official title: PREPARE-GI: Psychological Resilience, Emotional Processing, and Adaptation Prehabilitation Program for Complex GI Surgery Patients
Run by Northwestern University · NCT07865052 · Data updated 2026-11-12
A preoperative, structured psychological program called PREPARE-GI is tested to see if it helps adults with prior medical trauma undergoing complex GI surgery feel less stress, anxiety, and depression and recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | September 25, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07865052 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older scheduled for elective complex GI surgery at Northwestern Memorial Hospital, with PCL-5 score >31, and able to participate in English.
✕Probably not a fit
Patients with severe or unstable psychiatric conditions or inability to participate fully in follow-up may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study tests PREPARE-GI, a manualized, trauma-informed psychological prehabilitation program based on cognitive behavioral and transdiagnostic methods. It targets adults facing elective complex gastrointestinal surgery at Northwestern Memorial Hospital who have residual post-traumatic stress symptoms, anxiety, or depression. The study will assess feasibility, adherence to sessions and surveys, and preliminary effects on stress, anxiety, depression, pain, and quality of life, as well as hospital utilization after surgery. The protocol emphasizes safety, language accessibility, and follow-up assessments to inform a future multicenter randomized trial.
Why it matters
Potential benefit: If successful, PREPARE-GI could reduce perioperative distress and improve recovery outcomes for patients undergoing complex GI surgery.
How similar studies have gone: Previous research suggests psychological prehabilitation can help perioperative outcomes, but this specific trauma-informed approach in complex GI surgery is early-stage and primarily feasibility-focused.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Scheduled for elective complex gastrointestinal surgery at Northwestern Memorial Hospital * Surgery scheduled at least 8 weeks after enrollment * PTSD Checklist for DSM-5 (PCL-5) score greater than 31 on screening * Able to understand and provide informed consent * Able to complete study procedures and questionnaires in English Exclusion Criteria: * Unable to provide informed consent * Unable to complete study procedures in English * Severe or unstable psychiatric illness that would interfere with safe participation or completion of the intervention, including: active psychosis, uncontrolled bipolar disorder, active suicidal ideation requiring urgent psychiatric intervention, cognitive impairment limiting decision-making capacity, unable to participate in follow-up assessments, currently pregnant, incarcerated
Where it's running
-
Northwestern Memorial Hospital
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Michael Rosen, MD — Northwestern University
- Study coordinator: Maria Narvaez Pereyra, MD
- Email: maria.narvaezpereyra@northwestern.edu
- Phone: 561-271-5655
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Aromatherapy to support mental health in women undergoing IVF
This will test whether inhaling lavender oil twice daily can reduce anxiety, stress, and depression and improve quality of life for women awaiting IVF.
-
Mixed nuts to support mood, stress, and thinking in young adults
This trial will test whether eating a daily mix of nuts for six months helps improve mood, reduce anxiety and stress, and boost cognition and sleep in university students aged 18–25.
-
Two-week mindfulness or social-media reduction plus exercise program to improve college students' well-being
This project will test whether daily 15-minute mindfulness meditations or cutting 30 minutes of social media and replacing that time with exercise for two weeks can reduce social media use and improve well-being in Johns Hopkins students who use social media more than an hour a day.
-
Single-session intervention to change ambiguity aversion
This trial tests whether one brief intervention can change how adults with intolerance of uncertainty and anxiety make ambiguous decisions and how their brains respond.
-
See if preoperative anxiety affects recovery after major digestive cancer surgery
This study tests whether anxiety before surgery is linked to more complications after major digestive cancer operations in French-speaking adults.
-
Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges
This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.