The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis

Psychosis Clinical Trial

Official title:

The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis: A Randomized Control Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06194344
• Other study ID #: HSC-MS-23-0915
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Alia Warner, Ph.D., ABPP
• Phone: 713-486-2700
• Email: Alia.R.Warner[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Suicidal Ideation

Intervention

Behavioral:
• Individualized imagery
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
• Control
Participants will wear the earbuds, with use of Muse S headband to collect outcome data without the individualized imagery scripts.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )
Primary	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 )
Primary	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 )
Secondary	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
Secondary	Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI)	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
Secondary	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
Secondary	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
Secondary	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 )
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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