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NCT02059421 · ClinicalTrials.gov registry record · NA
Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT02059421 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 50 participants.
The verdict
NCT02059421, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in survivors of critical illness. Subjects will be recruited following discharge from the Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements will be made by portable (home-based) sleep studies and will wear a watch that measures sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and 6 weeks. The central purpose of this proposal is to perform a comparative-effectiveness study of a complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep disturbances in survivors of critical illness. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving sleep quality (Pittsburgh Sleep Quality Index \[PSQI\] and sleep efficiency \[measured by polysomnography\]). A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic markers of inflammation and urinary biomarkers of sleep and stress. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and stress. A tertiary objective is to determine whether the presence of insomnia or other sleep characteristics is associated with hospital readmissions within 30-days.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
- OTHER Johrei therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-01 |
| Est. Completion | 2023-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02059421
The ClinicalTrials.gov registry entry for NCT02059421 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT02059421 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02059421 about?
NCT02059421 is a clinical study titled "Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors". The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in survivors of critical illness. Subjects will be recruited following discharge from the Intensive Care Unit (ICU) and foll...
What is the current status of trial NCT02059421?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2014-01. Estimated completion is 2023-06.
What interventions are being tested in trial NCT02059421?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Johrei therapy (OTHER).
Who is sponsoring clinical trial NCT02059421?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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