Psychological Prehabilitation for Gastrointestinal Disease
(PREPARE-GI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a psychological program called PREPARE-GI can reduce stress and improve recovery for individuals facing complex digestive system surgeries. The program aims to ease stress, worry, and low mood from past medical experiences, potentially leading to less pain and shorter hospital stays post-surgery. Participants will either engage in this program before their surgery or receive standard surgical care. Adults with a complex GI surgery planned at least 8 weeks away, who experience high stress from past medical experiences, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative stress-reduction strategies before surgery.
What prior data suggests that the PREPARE-GI program is safe for participants?
Research has shown that prehabilitation programs, such as PREPARE-GI, are generally safe and manageable for patients. One study found that participants in prehabilitation recovered better and experienced fewer complications. They also had a lower likelihood of returning to the hospital within 30 days compared to those who did not participate.
Another study found improvements in patients' physical fitness and mental health, with no serious side effects reported. This suggests that prehabilitation, which includes psychological support, can safely prepare patients for surgery and recovery. Although this specific trial is small and new, these findings offer reassurance about the safety of joining such programs.12345Why are researchers excited about this trial?
Researchers are excited about the PREPARE-GI psychological prehabilitation program because it offers a proactive approach to mental health support for patients with gastrointestinal disease undergoing surgery. Unlike standard perioperative care, which only addresses acute mental health concerns reactively, PREPARE-GI integrates structured psychological support throughout the preparation for surgery. This approach aims to enhance patient resilience and potentially improve surgical outcomes by addressing the psychological aspects of recovery, which are often overlooked in traditional care settings.
What evidence suggests that the PREPARE-GI program is effective for reducing stress and improving recovery in GI surgery patients?
Research has shown that programs like PREPARE-GI, which prepare patients for digestive system surgery, can be very beneficial. In this trial, participants in the PREPARE-GI Psychological Prehabilitation arm will receive this program alongside standard perioperative care. Studies have found that such programs can shorten hospital stays and reduce pain, anxiety, and depression after surgery. Evidence also suggests they can lower the risk of postoperative complications and improve overall quality of life. These benefits are particularly evident in individuals stressed by past medical procedures. Thus, joining a program like PREPARE-GI before surgery could help manage stress and accelerate recovery.24678
Who Is on the Research Team?
Michael Rosen, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have a complex GI surgery planned at least 8 weeks from now at Northwestern Memorial Hospital, have high stress from past medical experiences based on a survey, and can complete the study in English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prehabilitation
Participants in the PREPARE-GI program meet with a psychologist for 8 sessions to learn stress management and emotional regulation skills
Surgery and Immediate Postoperative Care
Participants undergo complex GI surgery and receive standard perioperative care
Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessments of anxiety, depression, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- PREPARE-GI
Trial Overview
The study compares a psychological program called PREPARE-GI—eight one-on-one sessions with a psychologist before surgery—to usual surgical care. Participants are randomly assigned to either group. The goal is to see if the program helps reduce stress, anxiety, depression, pain, and improves recovery after GI surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive the PREPARE-GI psychological prehabilitation program in addition to standard perioperative care
Participants receive standard perioperative care without structured psychological support. Psychology or psychiatry referral is available only if an acute mental health concern arises, as in routine care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Citations
The effectiveness of prehabilitation interventions on ...
Current evidence supports prehabilitation as safe to preserve or improve preoperative function. Heterogeneity in outcomes and variable study ...
Impact of Prehabilitation in Major Gastrointestinal Oncological ...
Evidence indicates that prehabilitation can lead to shorter hospital stays, reduced intensive care admissions, a lower incidence of ...
Comparative effectiveness of different prehabilitation ...
Current evidence suggests that preoperative prehabilitation can improve patient status, reduce postoperative complication rates, shorten hospital stays, and ...
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gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/prehabilitation-improves-functional-and-psychological-recovery-after-esd/Prehabilitation Improves Functional and Psychological ...
A 4-week multimodal prehabilitation program before ESD improves postoperative functional recovery, muscle strength, and mental QOL.
Prehabilitation approaches for gastrointestinal cancer ...
This narrative review synthesizes existing literature to evaluate the effectiveness of prehabilitation interventions in improving outcomes for ...
Surgical Prehabilitation in Patients with Gastrointestinal Cancers
This systematic review aims to (1) evaluate the latest evidence of preoperative prehabilitation interventions on postoperative outcomes after gastrointestinal ( ...
Multimodal prehabilitation in gastrointestinal surgery
Compared with expected outcomes, participants demonstrated lower rates of 30-day mortality (observed-to-expected rate: 0.32), 30-day readmission (observed-to- ...
Exercise and nutritional prehabilitation in gastrointestinal ...
The primary aim was to assess key feasibility metrics and the safety of a supervised, individualized moderate-to-high intensity exercise program ...
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