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NCT Number: NCT06194344

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

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

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Key information

Conditions

Psychosis Behavior Behavioral Symptoms Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Alia Warner, Ph.D., ABPP

CONTACT

[email protected]

713-486-2700

Calvary Fielden

CONTACT

[email protected]

713-741-6087

Jessica Badawi, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Control

Behavioral

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

Primary outcomes

  1. 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 )

  2. 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 )

  3. Feasibility as assessed by a self-report satisfaction survey, Was It Worth It questionnaire

    Time frame: post-intervention(upto 80 days after baseline )

    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

Secondary outcomes

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

    Time frame: From Baseline to about 3 months after baseline

    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

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

    Time frame: From Baseline to about 3 months after baseline

    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.

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

    Time frame: From Baseline to about 3 months after baseline

    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

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

    Time frame: From Baseline to about 3 months after baseline

    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

  5. Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2)

    Time frame: From baseline to end of study (upto 80 days after baseline )

  6. Improvements in symptomology as assessed by the Beck Depression Inventory - II

    Time frame: From Baseline to about 3 months after baseline

    This is a 21-item questionnaire and each is scored from 0-3 for a maximum score of 63, higher score indicating worse outcome

  7. Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: From Baseline to about 3 months after baseline

    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.

  8. Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6)

    Time frame: From Baseline to about 3 months after baseline

    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.

  9. Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ)

    Time frame: From Baseline to about 3 months after baseline

    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

  10. Improvements in symptomology as assessed by the Posttraumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)

    Time frame: From Baseline to about 3 months after baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alia Warner, Ph.D., ABPP

CONTACT

[email protected]

713-486-2700

Calvary Fielden, B.S.

CONTACT

[email protected]

713-741-6087

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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