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Not yet recruiting NCT07010718

Improving Sleep in a Psychiatric Hospital

Phase I Interventional Sleep Disorder Mental Health Issue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scented Oil, Ear Plugs, Eye Mask, Video based safety check.
Who it may be relevant to
Registry conditions: Sleep Disorder, Mental Health Issue. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients

Overview

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.

Interventions

  • Drug Scented Oil
    inpatient-safe aromatherapy (scented oil)
  • Device Ear Plugs
    ingestible-safe ear plugs (noise blocking)
  • Device Eye Mask
    inpatient-safe eye mask (light blocking).
  • Behavioral Video based safety check
    video based safety checks will be conducted as long as participants are in bed and asleep
  • Behavioral In person safety check
    In person safety checks will be conducted every 30 minutes

Primary outcome measures

  • Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Change in insomnia as assessed by the Insomnia Severity Index (ISI) [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [Time frame: Admission, Discharge (about 2 weeks after admission )]
Secondary outcome measures (6)
  • Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R) [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS) [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9) [Time frame: Admission, Discharge (about 2 weeks after admission )]
  • Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT [Time frame: Each night during length of stay (about 2 weeks)]
  • Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT [Time frame: Each night during length of stay(about 2 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07010718 · HSC-MS-24-1035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗