Recruiting

Sleep Interventions

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06194344

Conditions

Psychosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Individualized imagery

Control

Study Details

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 ID

NCT06194344

Start date

Mar 5, 2024

Status verified date

Jul, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Individualized imagery

active comparator: Control

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

Control

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

Primary outcome measure

  • Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep) [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: post-intervention(upto 80 days after baseline ) ]

Central Contacts and Locations

Central contacts

Alia Warner, Ph.D., ABPP

713-486-2700Alia.R.Warner@uth.tmc.edu

Calvary Fielden, B.S.

713-741-6087Calvary.R.Fielden@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Alia Warner, Ph.D., ABPP

713-486-2700Alia.R.Warner@uth.tmc.edu

Calvary Fielden

713-741-6087Calvary.R.Fielden@uth.tmc.edu

Principal Investigator:

Jessica Badawi, Ph.D.

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 16, 2025

Last verified

Jul, 2025

Keywords

  • sleep therapy
  • suicidality
  • psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-07-16.