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NCT Number: NCT07010718

Improving Sleep in a Psychiatric Hospital

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.

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Key information

Conditions

Sleep Disorder Behavior Behavioral Symptoms Mental Disorders Mental Health Issue Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Sleep Wake Disorders Suicidal Ideation Suicide

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scented Oil

Drug

inpatient-safe aromatherapy (scented oil)

Ear Plugs

Device

ingestible-safe ear plugs (noise blocking)

eye mask

Device

inpatient-safe eye mask (light blocking).

Video based safety check

Behavioral

video based safety checks will be conducted as long as participants are in bed and asleep

In person safety check

Behavioral

In person safety checks will be conducted every 30 minutes

Primary outcomes

  1. Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The PSQI has 19 self rated questions with a global score range of 0 to 21.It has 7 components and each is scored from 0 (no difficulty) to 3(severe difficulty) with higher scores indicating poorer sleep quality.

  2. Change in insomnia as assessed by the Insomnia Severity Index (ISI)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The ISI is a 7-item , each item is rated on a 0 (no problem)-4 (very severe problem) scale, with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity.

  3. Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The ESS is an 8-item questionnaire. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

Secondary outcomes

  1. Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The SBQ-R is a 4-item questionnaire, each scored on a different scale. Total scores range from 3 to 18, with higher scores indicating greater suicide risk.

    Item 1 is scored from 1 [Never (1 point)] to 6 [I have attempted to kill myself more than once (6 points)] Item2 is scored from 1[Never (1 point)] to 5[Very often (5 or more times) (5 points)] Item 3 is scored from 1[No (1 point)] to 5[Yes, more than once, and really wanted to do it (5 points)] Item 3 is scored from 1[Never (1 point)] to 6 [Rather likely (6 points)]

  2. Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The Beck Scale for Suicide Ideation (BSS) is a 21-item questionnaire. The first 19 items are scored from 0(No ideation/symptom) to 2 (Severe ideation/symptom) for a maximum score of 38, higher scores indicate greater severity of suicidal ideation.

    The last 2 items assess past suicide attempts and intent to die during the most recent attempt. These are not included in the total score.

  3. Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The GAD-7 is a brief, 7-item questionnaire, and each is scored from 0(not at all) to 3( nearly every day) for a total score range of 0-21, higher score indicating severe anxiety symptoms

  4. Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)

    Time frame: Admission, Discharge (about 2 weeks after admission )

    The PHQ-9 is a 9-item questionnaire, each is scored from 0( not at all) to 3(nearly every day) for a total score range of 0-27, higher scores indicate greater severity of depressive symptoms.

  5. 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)

    Total Sleep Time (TST) is the total amount of actual sleep time recorded during the nighttime sleep period. This measure is objectively assessed using the ActiGraph wGT3X-BT, a validated wrist-worn accelerometer device that estimates sleep parameters based on movement data.TST is calculated as the sum of all sleep epochs during the main sleep period (typically nighttime) and is reported in minutes or hours.

  6. 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)

    Nighttime Awakenings refer to the number and/or duration of awakenings during the main sleep period, objectively measured by the ActiGraph wGT3X-BT wrist-worn accelerometer. The device detects movement patterns to identify sleep interruptions, providing an estimate of sleep fragmentation and overall sleep quality.

    The outcome will be reported as: Total number of awakenings per night

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Badawi

CONTACT

[email protected]

(713) 486-2700

Michelle Patriquin, PhD, ABPP

CONTACT

[email protected]

(713) 486-2700

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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