Post-traumatic Stress SymptomsPREPARE-GINCT07865052
Psychological Prehabilitation for Complex Gastrointestinal Surgery
A study testing PREPARE-GI in people with Post-traumatic Stress Symptoms and Anxiety, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Symptoms, Anxiety, Depression Disorder
- What is being tested?
- PREPARE-GI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Maria Narvaez Pereyra, MD, 561-271-5655, maria.narvaezpereyra@northwestern.edu
Michael Rosen, MD
About this study
Official title: PREPARE-GI: Psychological Resilience, Emotional Processing, and Adaptation Prehabilitation Program for Complex GI Surgery Patients
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.
Read more
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.
Read the detailed description
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:
- Psychoeducation about the stress and trauma response
- Mindfulness and present-focused awareness
- Cognitive flexibility strategies
- Emotion regulation skills
- Behavioral approaches to managing avoidance and distress Content is adapted to challenges specific to complex GI surgery, including medical trauma history, anticipatory anxiety about surgery and recovery, pain catastrophizing, and adjustment to chronic illness.
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.
- Being tested
- PREPARE-GI
- Keywords
- Psychological prehabilitation, Prehabilitation, Complex gastrointestinal surgery, Medical trauma, Perioperative care, Cognitive behavioral therapy, Unified Protocol, Pain catastrophizing, Postoperative recovery
- Medical subject headings
- Anxiety Disorders, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREPARE-GIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PREPARE-GI Psychological Prehabilitation | Experimental | Participants receive the PREPARE-GI psychological prehabilitation program in addition to standard perioperative care Receives: Behavioral: PREPARE-GI |
| Standard Perioperative Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Proportion of eligible screened individuals who consent and enroll in the study.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, and 3 months after surgery
Secondary outcomes (10)
Change in anxiety symptoms (GAD-7)
Generalized Anxiety Disorder-7. Total score range 0-21; higher scores indicate worse anxiety.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, and 3 months after surgery
Pain intensity (NRS)
Numeric Rating Scale for pain. Range 0-10; higher scores indicate worse pain.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of the index surgical procedure until the date of discharge from the hospital, assessed up to 6 months.
Hospital readmission
Any unplanned hospital readmission, abstracted from the medical record.
Measured: Within 30 days of discharge
Emergency department visits
Any emergency department visit, abstracted from the medical record.
Measured: Within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start25 Sep 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress SymptomsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to the PREPARE-GI psychological prehabilitation program plus standard perioperative care or to standard perioperative care alone.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
- Investigators
- Michael Rosen, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865052
- Sponsor's protocol ID
- STU00226488
- Acronym
- PREPARE-GI
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Pickard AS, Law EH, Jiang R, Pullenayegum E, Shaw JW, Xie F, Oppe M, Boye KS, Chapman RH, Gong CL, Balch A, Busschbach JJV. United States Valuation of EQ-5D-5L Health States Using an International Protocol. Value Health. 2019 Aug;22(8):931-941. doi: 10.1016/j.jval.2019.02.009. Epub 2019 May 25.
PubMed 31426935Alkhatib H, Tastaldi L, Krpata DM, Scheman J, Petro CC, Fafaj A, Rosenblatt S, Rosen MJ, Prabhu AS. Prevalence of posttraumatic stress disorder (PTSD) in patients with an incisional hernia. Am J Surg. 2019 Nov;218(5):934-939. doi: 10.1016/j.amjsurg.2019.03.002. Epub 2019 Mar 7.
PubMed 30878218Taft TH, Bedell A, Craven MR, Guadagnoli L, Quinton S, Hanauer SB. Initial Assessment of Post-traumatic Stress in a US Cohort of Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2019 Aug 20;25(9):1577-1585. doi: 10.1093/ibd/izz032.
PubMed 30840762Hall AE, Nguyen NH, Cascavita CT, Shariati K, Patel AK, Chen W, Kang Y, Ren X, Tseng CH, Hidalgo MA, Lee JC. The Impact of Psychological Prehabilitation on Surgical Outcomes: A Meta-analysis and Meta-regression. Ann Surg. 2025 Jun 1;281(6):928-941. doi: 10.1097/SLA.0000000000006677. Epub 2025 Feb 19.
PubMed 39969855Villa G, Lanini I, Amass T, Bocciero V, Scire Calabrisotto C, Chelazzi C, Romagnoli S, De Gaudio AR, Lauro Grotto R. Effects of psychological interventions on anxiety and pain in patients undergoing major elective abdominal surgery: a systematic review. Perioper Med (Lond). 2020 Dec 8;9(1):38. doi: 10.1186/s13741-020-00169-x.
PubMed 33292558Paredes AZ, Hyer JM, Diaz A, Tsilimigras DI, Pawlik TM. The Impact of Mental Illness on Postoperative Outcomes Among Medicare Beneficiaries: A Missed Opportunity to Help Surgical Patients? Ann Surg. 2020 Sep 1;272(3):419-425. doi: 10.1097/SLA.0000000000004118.
PubMed 32568745