The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis
- Conditions
- Psychosis
- Interventions
- Behavioral: ControlBehavioral: Individualized imagery
- Registration Number
- NCT06194344
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control - Individualized imagery Individualized imagery -
- Primary Outcome Measures
Name Time Method Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep) from start of intervention to end of intervention (upto 80 days after baseline ) Feasibility as assessed by percentage of nights used for the duration of the intervention. from start of intervention to end of intervention (upto 80 days after baseline ) Feasibility as assessed by a self-report satisfaction survey, Was It Worth It questionnaire post-intervention(upto 80 days after baseline ) The measure will consist of 7 items rated on a 5-point Likert scale ranging from Strongly Disagree (1) to Strongly Agree (5), for a maximum score of 35,higher number indicating better satisfaction
- Secondary Outcome Measures
Name Time Method Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS) From Baseline to about 3 months after baseline The PAS a 16-item questionnaire and each is scored on a 5-point Likert scale from 1 (not at all) to 5 (extremely), higher number indicating worse outcome
Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI) From Baseline to about 3 months after baseline DDNSI is a 5- item questionnaire. Scoring is done as follows:
Add nights/per week (0 to 7) + nightmares/week +Q3 which is scored from 0(never/rarely) to 4 (always) +Q4 which is scored from 0 (no problem) to 6 (extremely severe problem) + Q5 which is scored from 0 (not intense) to 6 (extremely severe intensity).Maximum for nightmares/week = 14, so scale is 0 to 14. Score \> 10 usually indicate a nightmare disorder.Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) From Baseline to about 3 months after baseline Interview administered assessment of suicide ideation and behavior. The interview consists of two subscales, an ideation and behavior subscale. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI) From Baseline to about 3 months after baseline The ISI is an instrument comprising seven questions, and each is scored from 0-7 for a score range of 0-28, a higher number indicating severe clinical insomnia
Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6) From Baseline to about 3 months after baseline This is a 6 item questionnaire and each is scored from 1 (Absent) - 7 (Extreme) with a maximum score of 42. The higher the score the greater the symptom severity.
Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ) From Baseline to about 3 months after baseline The PSQ is a 30-item questionnaire and each is scored from e from 1 ("almost never") to 4 ("usually"). Higher scores indicate greater levels of stress
Improvements in symptomology as assessed by the Posttraumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) From Baseline to about 3 months after baseline The PCL-5 is a 20-item questionnaire and each is measured on a 5-point Likert scale from 0(not at all) to 4(extremely), higher number indicating worse outcome
Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) From Baseline to about 3 months after baseline DBAS-16 is a 16-item questionnaire and each question is cored from 0( strongly disagree) to 10 (strongly agree) with higher scores indicating more dysfunctional beliefs and attitudes
Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2) From baseline to end of study (upto 80 days after baseline ) Improvements in symptomology as assessed by the Beck Depression Inventory - II From Baseline to about 3 months after baseline This is a 21-item questionnaire and each is scored from 0-3 for a maximum score of 63, higher score indicating worse outcome
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States