Clinical trial NCT06194344: The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis
Official title: The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis: A Randomized Control Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychosis
Keywords: sleep therapy
suicidality
psychosis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see how feasible is the use of compact EEG and paired audio technology to administer sleep interventions for inpatients with psychosis, to see if individuals that receive individualized technology-based sleep interventions experience improvements in sleep quality and to see if individuals that receive individualized technology-based sleep interventions experience improvements in symptomatology


Eligibility criteria: Inclusion Criteria:

* primary diagnoses of schizophrenia spectrum disorder or mood disorder with psychotic features, as determined by the treatment team or record review
* capacity to consent to the study as determined by licensed psychologists ( or the primary attending psychiatrist
* reported sleep dysfunction which will be determined by a subthreshold or more severe score ≥ 8 on the Insomnia Severity Index (ISI), and/or report experiencing nightmares at least once a week.

Exclusion Criteria:

* primary substance- or medical-induced psychosis
* intellectual and developmental disabilities
* neurodegenerative cognitive disorders
* implanted devices (e.g., Pacemakers)
* on one-to-one supervision or 15-minute safety checks for suicidality or aggression
* patients with roommates that are on 15-minute checks to minimize impact on study participants' awakenings

Primary outcomes:
measure: Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep)
timeFrame: from start of intervention to end of intervention (upto 80 days after baseline )
measure: Feasibility as assessed by percentage of nights used for the duration of the intervention.
timeFrame: from start of intervention to end of intervention (upto 80 days after baseline )
measure: Feasibility as assessed by a self-report satisfaction survey, Was It Worth It questionnaire
timeFrame: post-intervention(upto 80 days after baseline )
Secondary outcomes:
measure: Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2)
timeFrame: From baseline to end of study (upto 80 days after baseline )
measure: Improvements in symptomology as assessed by the Beck Depression Inventory - II
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ)
timeFrame: From Baseline to about 3 months after baseline
measure: Improvements in symptomology as assessed by the Posttraumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
timeFrame: From Baseline to about 3 months after baseline
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: Alia Warner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Jessica Badawi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: