CompletedNot Applicable

Sensation Awareness Focused Training for Spouses

United States10 participantsStarted 2017-09-03

Plain-language summary

The purpose of the feasibility study is prevention of Post Intensive Care Syndrome in Family (PICS-F), specifically in spouses of critically ill, mechanically ventilated patients, using a nonpharmacological intervention called Sensation Awareness Focused Training (SĀF-T). This will be accomplished using a prospective, randomized, experimental design to achieve robust and unbiased results.

Who can participate

Age range

18 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: * spouse of a critically ill, mechanically ventilated patient * within 36 hours of admission to adult Tampa General Hospital (TGH) ICUs * understands English Exclusion Criteria: * anticipation by the clinical provider of imminent patient death * spouse does not understand English * spouse is under the age of 18 years old * spouse is currently receiving treatment for an existing PICS condition (anxiety, depression or PTSD).

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

Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.

Change from Baseline Symptoms of Depression following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.

Change from Baseline Symptoms of Post Traumatic Stress Disorder following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.

Trial details

NCT IDNCT03129204

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-26

View on ClinicalTrials.gov More Post Intensive Care Syndrome trials

Plain-language summary

Who can participate

Age range

18 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.

What they're measuring

Change from Baseline Symptoms of Anxiety following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.

Change from Baseline Symptoms of Depression following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.

Change from Baseline Symptoms of Post Traumatic Stress Disorder following ICU discharge and at 1 and 3 months post hospital discharge

Timeframe: Four time points: 1) upon study enrollment, 2) at least 24 hours post ICU discharge, 3) 1 month post hospital discharge, and 4) 3 months post hospital discharge.