Psychological Prehabilitation for Complex Gastrointestinal Surgery

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07865052
Status
Recruiting
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Conditions

  • Anxiety
  • Depression Disorder
  • Gastrointestinal Disease
  • Post-traumatic Stress Symptoms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PREPARE-GI — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Oct 8, 2026
Start date
Sep 25, 2026
Status verified
Oct 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: PREPARE-GI Psychological Prehabilitation
    Participants receive the PREPARE-GI psychological prehabilitation program in addition to standard perioperative care
  • No Intervention: 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.

Primary Outcome Measure

Enrollment rate [ Time Frame: Throughout the recruitment period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Maria Narvaez Pereyra, MD
[email protected]
561-271-5655
Michael Rosen, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern Memorial Hospital· Chicago, IL

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