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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (10)

• Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2) [Срок оценки: From baseline to end of study (upto 80 days after baseline )]
• Improvements in symptomology as assessed by the Beck Depression Inventory - II [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6) [Срок оценки: From Baseline to about 3 months after baseline]
• Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ) [Срок оценки: 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) [Срок оценки: From Baseline to about 3 months after baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06194344 · HSC-MS-23-0915

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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