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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized imagery | Experimental |
| |
| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized imagery | Behavioral | Study personnel will assist participants to create scripts that foster relaxation and safety. Objects, places, and/or scenarios that foster participant relaxation, sense of safety, and/or positive emotions will be identified. Participants will write or type the generated scenario using highly detailed elements (e.g., including visual, olfactory, auditory, tactile, and gustatory sensations, as applicable) associated with the imagery. Study personnel will assist with recording the imagery scripts; audio files will be recorded using an audio recording application. The imagery scripts will be played at night via Bluetooth earbuds connected to the Muse app and script recording while laying down to sleep. The imagery rehearsal prompts will play for approximately 15 minutes, based on 10-20-minute recommendations across imagery rehearsal therapy (IRT) studies |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | post-intervention(upto 80 days after baseline ) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI) | 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 | From Baseline to about 3 months after baseline |
| Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alia Warner, Ph.D., ABPP | Contact | 713-486-2700 | Alia.R.Warner@uth.tmc.edu | |
| Calvary Fielden, B.S. | Contact | 713-741-6087 | Calvary.R.Fielden@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alia Warner, Ph.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Jessica Badawi, Ph.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| Control | Behavioral | Participants will wear the earbuds, with use of Muse S headband to collect outcome data without the individualized imagery scripts. |
|
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. |
| From Baseline to about 3 months after baseline |
| Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS) | 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 | From Baseline to about 3 months after baseline |
| Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) | 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 | From Baseline to about 3 months after baseline |
| 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 | This is a 21-item questionnaire and each is scored from 0-3 for a maximum score of 63, higher score indicating worse outcome | From Baseline to about 3 months after baseline |
| Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | From Baseline to about 3 months after baseline |
| Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6) | 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. | From Baseline to about 3 months after baseline |
| Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ) | 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 | From Baseline to about 3 months after baseline |
| Improvements in symptomology as assessed by the Posttraumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) | 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 | From Baseline to about 3 months after baseline |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |