PsychosisNCT06194344
The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis
A study testing Individualized imagery in people with Psychosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis
- What is being tested?
- Individualized imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Alia Warner, Ph.D., ABPP, 713-486-2700, Alia.R.Warner@uth.tmc.edu
Calvary Fielden, 713-741-6087, Calvary.R.Fielden@uth.tmc.edu
About this study
Official title: 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
- Conditions
- Psychosis
- Being tested
- Individualized imagery, Control
- Keywords
- sleep therapy, suicidality, psychosis
- Medical subject headings
- Psychotic Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized imageryBehavioural
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
ControlBehavioural
Participants will wear the earbuds, with use of Muse S headband to collect outcome data without the individualized imagery scripts.
| Study group | Role | What they receive |
|---|---|---|
| Individualized imagery | Experimental | Not described Receives: Behavioral: Individualized imagery |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep)
Measured: 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.
Measured: 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
Measured: post-intervention(upto 80 days after baseline )
Secondary outcomes (10)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: From Baseline to about 3 months after baseline
Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From Baseline to about 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start5 Mar 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Warner, The University of Texas Health Science Center, Houston
- Investigators
- Alia Warner, Ph.D., Principal investigator, The University of Texas Health Science Center, HoustonJessica Badawi, Ph.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194344
- Sponsor's protocol ID
- HSC-MS-23-0915
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis: A Randomized Control Pilot Study
- ClinicalTrials.gov ID
- NCT06194344
- Acronym / sponsor ID
- HSC-MS-23-0915
- Conditions
- Psychosis
- Keywords
- sleep therapy, suicidality, psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized imagery | Experimental | Behavioral: Individualized imagery |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized imageryStudy 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 | Behavioural | Individualized imagery |
| ControlParticipants will wear the earbuds, with use of Muse S headband to collect outcome data without the individualized imagery scripts. | Behavioural | Control |
Primary outcome
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 )
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
10 secondary outcomes
Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI)
Time frame: From Baseline to about 3 months after baseline
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
Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS)
Time frame: From Baseline to about 3 months after baseline
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
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 )
Improvements in symptomology as assessed by the Beck Depression Inventory - II
Time frame: From Baseline to about 3 months after baseline
Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline to about 3 months after baseline
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
Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ)
Time frame: 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)
Time frame: From Baseline to about 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alia Warner, Ph.D. principal investigator
The University of Texas Health Science Center, Houston
Jessica Badawi, Ph.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized imagery in people with Psychosis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alia Warner, Ph.D., ABPP (713-486-2700, Alia.R.Warner@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 )). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.