Improving Sleep in a Psychiatric Hospital
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe University of Texas Health Science Center, Houston
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Scented Oil
Druginpatient-safe aromatherapy (scented oil)
Ear Plugs
Deviceingestible-safe ear plugs (noise blocking)
Eye Mask
Deviceinpatient-safe eye mask (light blocking).
Video based safety check
Behavioralvideo based safety checks will be conducted as long as participants are in bed and asleep
In person safety check
BehavioralIn person safety checks will be conducted every 30 minutes
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sleep promotionExperimental treatment 5 interventions
Group B: Treatment as usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame
Admission, Discharge (about 2 weeks after admission )2
Change in insomnia as assessed by the Insomnia Severity Index (ISI)
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.
Time frame
Admission, Discharge (about 2 weeks after admission )3
Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
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.
Time frame
Admission, Discharge (about 2 weeks after admission )Secondary outcomes
1
Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)
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 \[Rather likely (6 points)\]
Time frame
Admission, Discharge (about 2 weeks after admission )2
Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)
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.
Time frame
Admission, Discharge (about 2 weeks after admission )3
Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale
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
Time frame
Admission, Discharge (about 2 weeks after admission )4
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
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.
Time frame
Admission, Discharge (about 2 weeks after admission )Sponsors and contacts
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Source ClinicalTrials.gov
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