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

NCT ID: NCT06194344

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized imagery

Group Type: EXPERIMENTAL

Individualized imagery

Intervention Type: 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

Control

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Alia Warner

Associate Warner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alia Warner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Jessica Badawi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alia Warner, Ph.D., ABPP

Role: CONTACT

Alia.R.Warner@uth.tmc.edu

713-486-2700

Calvary Fielden, B.S.

Role: CONTACT

Calvary.R.Fielden@uth.tmc.edu

713-741-6087

Facility Contacts

Alia Warner, Ph.D., ABPP

Role: primary

Alia.R.Warner@uth.tmc.edu

713-486-2700

Calvary Fielden

Role: backup

Calvary.R.Fielden@uth.tmc.edu

713-741-6087

Other Identifiers

HSC-MS-23-0915

Identifier Type: -

Identifier Source: org_study_id