[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659556":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":63,"studyPopulation":55,"armGroups":64,"interventions":75,"overallOfficials":81,"centralContacts":85,"locations":91,"responsibleParty":109,"collaborators":55,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":78,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":55,"enrollmentInfo":121,"targetDuration":55,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":94,"whyStopped":55,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Northwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":55},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Enrollment rate","Proportion of eligible screened individuals who consent and enroll in the study.","Throughout the recruitment period",{"measure":14,"description":15,"timeFrame":16},"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.","From first session (approximately 8 weeks before surgery) through 3 weeks after hospital discharge, an average of 12 weeks",{"measure":18,"description":19,"timeFrame":20},"Assessment completion rate","Proportion of scheduled study questionnaires completed by participants in both arms.","Baseline, 1 month, and 3 months after surgery",[22,25,28,31,34,38,41,44,48,52],{"measure":23,"description":24,"timeFrame":20},"Change in anxiety symptoms (GAD-7)","Generalized Anxiety Disorder-7. Total score range 0-21; higher scores indicate worse anxiety.",{"measure":26,"description":27,"timeFrame":20},"Change in post-traumatic stress symptoms (PCL-5)","PTSD Checklist for DSM-5. Total score range 0-80; higher scores indicate greater symptom severity.",{"measure":29,"description":30,"timeFrame":20},"Change in depressive symptoms (PHQ-9)","Patient Health Questionnaire-9. Total score range 0-27; higher scores indicate worse depression.",{"measure":32,"description":33,"timeFrame":20},"Change in somatic symptom severity (PHQ-15)","Patient Health Questionnaire-15. Total score range 0-30; higher scores indicate greater somatic symptom burden.",{"measure":35,"description":36,"timeFrame":37},"Pain intensity (NRS)","Numeric Rating Scale for pain. Range 0-10; higher scores indicate worse pain.","Baseline, postoperative days 1-4, 1 month, and 3 months after surgery",{"measure":39,"description":40,"timeFrame":20},"Change in pain catastrophizing (PCS)","Pain Catastrophizing Scale. Total score range 0-52; higher scores indicate greater catastrophizing.",{"measure":42,"description":43,"timeFrame":20},"Change in health-related quality of life (EQ-5D)","EQ-5D-5L descriptive system across five dimensions (mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression), 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.",{"measure":45,"description":46,"timeFrame":47},"Hospital length of stay","Number of days from surgery to discharge during the index hospitalization, abstracted from the medical record.","Index surgical hospitalization",{"measure":49,"description":50,"timeFrame":51},"Hospital readmission","Any unplanned hospital readmission, abstracted from the medical record.","Within 30 days of discharge",{"measure":53,"description":54,"timeFrame":51},"Emergency department visits","Any emergency department visit, abstracted from the medical record.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 to the PREPARE-GI psychological prehabilitation program plus standard perioperative care or to standard perioperative care alone.","SUPPORTIVE_CARE",{"masking":62,"maskingDescription":55,"whoMasked":55},"NONE","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.\n\nIntervention Content\n\nPREPARE-GI is a manualized psychological prehabilitation program drawing on cognitive behavioral and transdiagnostic principles, including:\n\n* Psychoeducation about the stress and trauma response\n* Mindfulness and present-focused awareness\n* Cognitive flexibility strategies\n* Emotion regulation skills\n* 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.\n\nComparison 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.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"PREPARE-GI Psychological Prehabilitation","EXPERIMENTAL","Participants receive the PREPARE-GI psychological prehabilitation program in addition to standard perioperative care",[70],"Behavioral: PREPARE-GI",{"label":72,"type":73,"description":74,"interventionNames":55},"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.",[76],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":55},"BEHAVIORAL","PREPARE-GI","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.",[66],[82],{"name":83,"affiliation":5,"role":84},"Michael Rosen, MD","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":55,"email":90},"Maria Narvaez Pereyra, MD","CONTACT","561-271-5655","maria.narvaezpereyra@northwestern.edu",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Northwestern Memorial Hospital","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-87.65005,41.85003,{"lat":104,"lon":103},[107,108],{"name":87,"role":88,"phone":89,"phoneExt":55,"email":90},{"name":83,"role":84,"phone":55,"phoneExt":55,"email":55},{"type":84,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Megan Melland-Smith","Assistant Professor","100659556","psychological-prehabilitation-for-complex-gastrointestinal-surgery-100659556",false,"NCT07865052","Psychological Prehabilitation for Complex Gastrointestinal Surgery","PREPARE-GI: Psychological Resilience, Emotional Processing, and Adaptation Prehabilitation Program for Complex GI Surgery Patients","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective complex gastrointestinal surgery at Northwestern Memorial Hospital\n* Surgery scheduled at least 8 weeks after enrollment\n* PTSD Checklist for DSM-5 (PCL-5) score greater than 31 on screening\n* Able to understand and provide informed consent\n* Able to complete study procedures and questionnaires in English\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable to complete study procedures in English\n* 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","ALL","18 Years",{"count":122,"type":123},20,"ESTIMATED","INTERVENTIONAL",[126],"NA","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.\n\nMany 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.\n\nThe main questions this study aims to answer are:\n\n* Can researchers sign up enough participants, and will participants attend the program sessions and finish the surveys?\n* Does the program lower stress, worry (anxiety), and low mood (depression)?\n* Does the program lower pain and improve quality of life after surgery?\n* Does the program shorten hospital stays or lower return visits to the hospital or emergency room?\n\nResearchers 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.\n\nAdults may be able to join if they:\n\nAre 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\n\nAll participants will:\n\nAnswer 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.\n\nRate 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.\n\nParticipants 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.\n\nIn the sessions, participants will learn skills to manage stress, handle difficult feelings, and prepare for surgery and recovery.\n\nParticipants 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.\n\nThis is a small study with 20 participants. The results will help researchers plan a larger study in the future.",[129,130,131,132],"Post-traumatic Stress Symptoms","Anxiety","Depression Disorder","Gastrointestinal Disease",[134,135,136,137,138,139,140,141,142],"Psychological prehabilitation","Prehabilitation","Complex gastrointestinal surgery","Medical trauma","Perioperative care","Cognitive behavioral therapy","Unified Protocol","Pain catastrophizing","Postoperative recovery","2026-10-05",{"date":145,"type":146},"2026-10-08","ACTUAL",{"date":148,"type":146},"2026-09-25",{"date":150,"type":123},"2027-07-31",{"name":5,"class":6},1]