An interventional study of PREPARE-GI in Post-traumatic Stress Symptoms, Anxiety and Depression Disorder, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Northwestern University · Not applicable, Interventional, and Supportive care
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:
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.
Background and Rationale Adults undergoing elective complex gastrointestinal surgery often have extensive histories of prior operations, prolonged hospitalizations, emergency care, and chronic illness. These experiences may contribute to post-traumatic stress symptoms, anxiety, and depression. Psychological distress is associated with longer length of stay, higher complication rates, and greater healthcare utilization after surgery. Psychological prehabilitation is a promising strategy to improve perioperative outcomes, but prospective evidence for structured, trauma-informed interventions in this population is limited. Transdiagnostic cognitive behavioral approaches, such as the Unified Protocol, target shared mechanisms underlying anxiety, depression, and post-traumatic stress. They have shown effectiveness across medical and psychiatric populations but have not been adequately studied in complex GI surgery. This pilot study will generate feasibility data and preliminary effect size estimates to inform a future multicenter randomized controlled trial.
Intervention Content
PREPARE-GI is a manualized psychological prehabilitation program drawing on cognitive behavioral and transdiagnostic principles, including:
Comparison with Standard Care At Northwestern Memorial Hospital, patients undergoing complex GI surgery do not routinely receive structured psychological support. Psychology or psychiatry referral is available only reactively, if an acute concern arises. PREPARE-GI differs from standard care in four ways. It is proactive, initiated through systematic screening. It is structured and manualized rather than ad hoc. It focuses on building coping capacity before surgery rather than treating crises. It provides continuity across the pre- and postoperative period.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Northwestern University is the lead sponsor of 1,398 studies on the registry; 201 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive the PREPARE-GI psychological prehabilitation program in addition to standard perioperative care
Behavioral: PREPARE-GI
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.
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.
Enrollment rate
Proportion of eligible screened individuals who consent and enroll in the study.
Time frame: Throughout the recruitment period
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 weeks
Assessment completion rate
Proportion of scheduled study questionnaires completed by participants in both arms.
Time frame: Baseline, 1 month, and 3 months after surgery
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 surgery
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 surgery
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 surgery
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 surgery
Pain intensity (NRS)
Numeric Rating Scale for pain. Range 0-10; higher scores indicate worse pain.
Time frame: Baseline, postoperative days 1-4, 1 month, and 3 months after surgery
Change in pain catastrophizing (PCS)
Pain Catastrophizing Scale. Total score range 0-52; higher scores indicate greater catastrophizing.
Time frame: Baseline, 1 month, and 3 months after surgery
Change in health-related quality of life (EQ-5D)
EQ-5D-5L descriptive system across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), converted to an index value using the US value set (Pickard et al., 2019). Index values range from -0.573 to 1.000, where 1.000 represents full health, 0 represents a state equivalent to death, and negative values represent states considered worse than death. Higher values indicate better health.
Time frame: Baseline, 1 month, and 3 months after surgery
Hospital length of stay
Number of days from surgery to discharge during the index hospitalization, abstracted from the medical record.
Time frame: Index surgical hospitalization
Hospital readmission
Any unplanned hospital readmission, abstracted from the medical record.
Time frame: Within 30 days of discharge
Emergency department visits
Any emergency department visit, abstracted from the medical record.
Time frame: Within 30 days of discharge
Plan to share: No — There is currently no plan to make individual participant data available to other researchers. This is a small single-site pilot study involving sensitive mental health data.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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