Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors
NCT02059421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-04-16
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.
Conditions
- Sleep Disturbances in Survivors of Critical Illness
Interventions
- BEHAVIORAL
-
Cognitive Behavioral Therapy for Insomnia (CBT-I)
\- Therapy session administered by a clinical psychologist using web-based video conferencing software. Therapy sessions will include: * Sleep restriction therapy * Stimulus control instructions * Sleep hygiene education
- OTHER
-
Johrei therapy
* Therapy will be administered by a senior Johrei administrator at the University of Arizona or the patient's residence. * Therapy sessions will consist of 3 sessions per week lasting 30 minutes each. * Therapist will wash his hands and and pray for 1 minute while facing the subject at a distance. * Therapy will be administered without physical contact. * During therapy the administrator will sit adjacent to the patient and channel energy from his palm towards the patient.
Sponsors & Collaborators
-
The Johrei Institute
collaborator UNKNOWN -
University of Arizona
lead OTHER
Principal Investigators
-
Sairam Parthasarathy, MD · University of Arizona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2023-06-30
- Completion
- 2023-06-30
Countries
- United States
Study Locations
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