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

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

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

Study Overview

• Status: Recruiting
• Conditions: Psychosis
• Intervention / Treatment: Behavioral: Individualized imagery; Behavioral: Control

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alia Warner, Ph.D., ABPP; Phone Number: 713-486-2700; Email: Alia.R.Warner@uth.tmc.edu
• Study Contact Backup: Name: Calvary Fielden, B.S.; Phone Number: 713-741-6087; Email: Calvary.R.Fielden@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Alia Warner, Ph.D., ABPP; Phone Number: 713-486-2700; Email: Alia.R.Warner@uth.tmc.edu
      • Contact: Calvary Fielden; Phone Number: 713-741-6087; Email: Calvary.R.Fielden@uth.tmc.edu
      • Principal Investigator: Jessica Badawi, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Behavioral: Control; Participants will wear the earbuds, with use of Muse S headband to collect outcome data without the individualized imagery scripts.
Experimental: Individualized imagery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 )

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: psychosis; suicidality; sleep therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Self-Injurious Behavior; Suicide; Psychotic Disorders; Suicidal Ideation; Mental Disorders
• Other Study ID Numbers: HSC-MS-23-0915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No