RecruitingNot applicable

Psychological Prehabilitation for Complex Gastrointestinal Surgery

PREPARE-GI: Psychological Resilience, Emotional Processing, and Adaptation Prehabilitation Program for Complex GI Surgery Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The surveys will take about 20 to 30 minutes to complete."
  • "Participants will be in the study for about 5 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PREPARE-GI, a program before surgery, can ease stress and help recovery compared with usual care. It is for adults with lasting stress from past medical experiences who plan to have complex surgery on their digestive system. The program includes 8 one-on-one sessions with a psychologist.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have planned complex surgery on your digestive system at Northwestern Memorial Hospital.
  • Your surgery is at least 8 weeks after you join the study.
  • You score above 31 on the PCL-5, a survey about stress symptoms after upsetting events.
  • You can understand the study and agree to take part.
  • You can complete study tasks and surveys in English.

Who can't join

  • You cannot understand the study or agree to take part.
  • You cannot complete study tasks in English.
  • You have a severe or unstable mental illness that would make taking part unsafe or prevent you from finishing, such as losing touch with reality or uncontrolled bipolar disorder (extreme mood swings).
  • You have thoughts of suicide that need urgent mental health care.
  • You have thinking or memory problems that limit your ability to make decisions.
  • You cannot take part in follow-up checks.
  • You are currently pregnant.
  • You are in jail or prison.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

IL