Psychological Prehabilitation for Complex Gastrointestinal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PREPARE-GI
BehavioralA 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PREPARE-GI Psychological PrehabilitationExperimental treatment 1 intervention
Group B: Standard Perioperative CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Enrollment rate
Proportion of eligible screened individuals who consent and enroll in the study.
Time frame
Throughout the recruitment period2
Intervention session completion
Number of PREPARE-GI sessions completed (out of 8) per participant in the intervention arm. Feasibility will be considered successful if at least 50% of intervention participants complete all 8 sessions.
Time frame
From first session (approximately 8 weeks before surgery) through 3 weeks after hospital discharge, an average of 12 weeks3
Assessment completion rate
Proportion of scheduled study questionnaires completed by participants in both arms.
Time frame
Baseline, 1 month, and 3 months after surgerySecondary outcomes
1
Change in anxiety symptoms (GAD-7)
Generalized Anxiety Disorder-7. Total score range 0-21; higher scores indicate worse anxiety.
Time frame
Baseline, 1 month, and 3 months after surgery2
Change in post-traumatic stress symptoms (PCL-5)
PTSD Checklist for DSM-5. Total score range 0-80; higher scores indicate greater symptom severity.
Time frame
Baseline, 1 month, and 3 months after surgery3
Change in depressive symptoms (PHQ-9)
Patient Health Questionnaire-9. Total score range 0-27; higher scores indicate worse depression.
Time frame
Baseline, 1 month, and 3 months after surgery4
Change in somatic symptom severity (PHQ-15)
Patient Health Questionnaire-15. Total score range 0-30; higher scores indicate greater somatic symptom burden.
Time frame
Baseline, 1 month, and 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov