Improving Sleep in a Psychiatric Hospital (NCT07010718) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Improving Sleep in a Psychiatric Hospital
United States40 participantsStarted 2025-06-01
Plain-language summary
The purpose of this study is to examine effects of sleep promotion versus treatment as usual (TAU) on subjective, self-reported sleep while in inpatient psychiatric treatment, to examine effects of sleep promotion vs. TAU/sleep disruption on self-reported depression, anxiety, suicide risk across inpatient length of stay, readmission at 72 hours, objective sleep and to compare implementation outcomes of acceptability and feasibility of sleep promotion relative to TAU/sleep disruption as reported by patients, clinicians, and clinic leaders using mixed methods.
Who can participate
Age range
18 Years – 90 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:
* Admitted voluntarily to inpatient psychiatric hospital for suicidal ideation or behavior.
* Continue to express suicide risk on the Suicide Behaviors Questionnaire-Revised (SBQ-R) of ≥8 at admission.
* Cognitive ability as tested by the Montreal Cognitive Assessment (MoCA) of \> 23.
* Have sufficient communication and comprehension ability to consent to the study
* English speaking
Exclusion Criteria:
* Intellectual disability/unable to give informed consent.
* Patients with one-to-one supervision or 15-minute (Q15) safety checks for suicidality or aggression will be unable to enroll in the study until these restrictions are discontinued.
* Patients with roommates that are on one-to-one supervision or Q15 safety checks for suicidality or aggression.
* Patients enrolled in the study with a patient admitted as their roommate who requires one-to-one supervision or Q15 checks-Patient will be unenrolled if a room change is not possible.
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
Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timeframe: Admission, Discharge (about 2 weeks after admission )
2
Change in insomnia as assessed by the Insomnia Severity Index (ISI)
Timeframe: Admission, Discharge (about 2 weeks after admission )
3
Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Timeframe: Admission, Discharge (about 2 weeks after admission )
Trial details
NCT IDNCT07010718
SponsorThe University of Texas Health Science Center, Houston