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

NCT06194344 | Recruiting

• 1 other identifier: HSC-MS-23-0915
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Psychosis

Keywords

sleep therapy; suicidality; psychosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI)

  From Baseline to about 3 months after baseline

• Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI)

  From Baseline to about 3 months after baseline

• Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS)

  From Baseline to about 3 months after baseline

• Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)

  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 )

Study Arms (2)

Individualized imagery

EXPERIMENTAL

Behavioral: Individualized imagery

Control

ACTIVE COMPARATOR

Behavioral: Control

Interventions

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

Individualized imagery

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Suicidal Ideation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• 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

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Warner

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 8, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)