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NCT07865052
Psychological Prehabilitation for Complex Gastrointestinal Surgery
Conditions: Post-traumatic Stress Symptoms, Anxiety, Depression Disorder, Gastrointestinal Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Northwestern University
Location: Northwestern Memorial Hospital Chicago Illinois
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.
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
Source: ClinicalTrials.gov (NCT07865052). StuddyBuddy aggregates publicly available trial information.