Clinical trial NCT07010718: Improving Sleep in a Psychiatric Hospital
Official title: Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Sleep Disorder
Mental Health Issue
Keywords: suicidal ideation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Change in insomnia as assessed by the Insomnia Severity Index (ISI)
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: Admission, Discharge (about 2 weeks after admission )
Secondary outcomes:
measure: Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Admission, Discharge (about 2 weeks after admission )
measure: Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT
timeFrame: Each night during length of stay (about 2 weeks)
measure: Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT
timeFrame: Each night during length of stay(about 2 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Michelle Patriquin, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References: