Recruiting

PREPARE-GI

Sponsor:

Northwestern University

Code:

NCT07865052

Conditions

Post-traumatic Stress Symptoms

Anxiety

Depression Disorder

Gastrointestinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PREPARE-GI

Study Details

Brief summary:

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.

Conditions

Post-traumatic Stress Symptoms

Anxiety

Depression Disorder

Gastrointestinal Disease

Study ID

NCT07865052

Start date

Sep 25, 2026

Status verified date

Oct, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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 measure

  • Enrollment rate [ Time Frame: Throughout the recruitment period ]
  • Intervention session completion [ Time Frame: From first session (approximately 8 weeks before surgery) through 3 weeks after hospital discharge, an average of 12 weeks ]
  • Assessment completion rate [ Time Frame: Baseline, 1 month, and 3 months after surgery ]

Central Contacts and Locations

Central contacts

Maria Narvaez Pereyra, MD

561-271-5655maria.narvaezpereyra@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Maria Narvaez Pereyra, MD

561-271-5655maria.narvaezpereyra@northwestern.edu

Principal Investigator:

Michael Rosen, MD

More Information

Sponsor

Northwestern University

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Psychological prehabilitation
  • Prehabilitation
  • Complex gastrointestinal surgery
  • Medical trauma
  • Perioperative care
  • Cognitive behavioral therapy
  • Unified Protocol
  • Pain catastrophizing
  • Postoperative recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.