Improving Sleep in a Psychiatric Hospital

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Change in insomnia as assessed by the Insomnia Severity Index (ISI) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]

Вторичные конечные точки (6)

• Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9) [Срок оценки: Admission, Discharge (about 2 weeks after admission )]
• Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT [Срок оценки: Each night during length of stay (about 2 weeks)]
• Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT [Срок оценки: Each night during length of stay(about 2 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT07010718 · HSC-MS-24-1035

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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