Building Resilience for Surgical Recovery (NCT06174701) | Clinical Trial Compass
CompletedNot Applicable
Building Resilience for Surgical Recovery
United States29 participantsStarted 2024-06-04
Plain-language summary
The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* ≥ 65 years of age on the day of surgery
* Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures
* Depressive symptoms - Patient Health Questionnaire (PHQ-9) screening with a score of 5+, 5-9 being subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, we need to have at least one of these items included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2)
Exclusion criteria:
* Those with severe cognitive impairment - Short Portable Mental Status Questionnaire (SPMSQ) screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment
* Unable to read, speak, and understand English
* Current alcohol or other substance abuse (scoring 2+ on CAGE questionnaire or answering yes to "Do you currently use any non-prescription drugs or substances?")
* Life expectancy is 6 months or less
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
Timeframe: 6 months after baseline
Trial details
NCT IDNCT06174701
SponsorThe University of Texas Health Science Center, Houston