NCT07865052 · Northwestern University
Psychological Prehabilitation for Complex Gastrointestinal Surgery
(PREPARE-GI)
What this study is about
The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. The program is called PREPARE-GI. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery. Many people who need complex GI surgery have been through a lot.
View original scientific description
The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. The program is called PREPARE-GI. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery. Many people who need complex GI surgery have been through a lot. They may have had many surgeries, hospital stays, or emergency visits. These experiences can leave lasting stress, worry, and low mood. These feelings can make recovery from surgery harder. The main questions this study aims to answer are: * Can researchers sign up enough participants, and will participants attend the program sessions and finish the surveys? * Does the program lower stress, worry (anxiety), and low mood (depression)? * Does the program lower pain and improve quality of life after surgery? * Does the program shorten hospital stays or lower return visits to the hospital or emergency room? Researchers will compare two groups. One group will take part in the PREPARE-GI program. The other group will get usual surgical care. Participants will be placed in a group by chance, like flipping a coin. Adults may be able to join if they: Are 18 or older Have complex GI surgery planned at Northwestern Memorial Hospital at least 8 weeks away Score high on a short survey about stress from past experiences Can complete the study in English All participants will: Answer survey questions about stress, worry, mood, body symptoms, pain, and quality of life. They will do this before surgery, then 1 month and 3 months after surgery. The surveys will take about 20 to 30 minutes to complete. Rate their pain on a scale from 0 to 10 after surgery. Allow researchers to review their medical records for information about their surgery and recovery. Participants in the program group will also meet one-on-one with a licensed psychologist for 8 sessions. Each session lasts about 1 hour and will take place either in person or by secure video from home. In the sessions, participants will learn skills to manage stress, handle difficult feelings, and prepare for surgery and recovery. Participants will be in the study for about 5 months. Participants in the program group will spend about 9 to 10 hours on the study. Participants in the usual care group will spend about 1 to 1.5 hours. This is a small study with 20 participants. The results will help researchers plan a larger study in the future.
Interventions
BEHAVIORAL
PREPARE-GI
A structured psychological prehabilitation program delivered by a licensed clinical psychologist. It consists of eight individual sessions of approximately 1 hour each, spanning the pre- and postoperative period. Sessions are delivered in person or via HIPAA-compliant telehealth. The program uses transdiagnostic cognitive behavioral strategies, adapted for patients with medical trauma history undergoing complex gastrointestinal surgery.
Primary outcome measures
Enrollment rate
Time frame: Throughout the recruitment period
Proportion of eligible screened individuals who consent and enroll in the study.
Intervention session completion
Time frame: From first session (approximately 8 weeks before surgery) through 3 weeks after hospital discharge, an average of 12 weeks
Number of PREPARE-GI sessions completed (out of 8) per participant in the intervention arm. Feasibility will be considered successful if at least 50% of intervention participants complete all 8 sessions.
Assessment completion rate
Time frame: Baseline, 1 month, and 3 months after surgery
Proportion of scheduled study questionnaires completed by participants in both arms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations