This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Johrei Institute
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT02059421
First received: February 6, 2014
Last updated: May 3, 2017
Last verified: May 2016
  Purpose

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.


Condition Intervention
Sleep Disturbances in Survivors of Critical Illness Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) Other: Johrei therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative-effectiveness of Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI) (CBT-I, Johrei therapy) [ Time Frame: 2 weeks ]
    Used to measure sleep quality

  • Polysomnography (CBT-I, Johrei therapy) [ Time Frame: 6 weeks ]
    Used to measure sleep efficiency

  • Pittsburgh Sleep Quality Index (PSQI) (CBT-I, Johrei therapy) [ Time Frame: 6 weeks ]
    Used to measure sleep quality.


Secondary Outcome Measures:
  • Actigraphy (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Objectively measures periods of quiescence that could be inferred to be sleep.

  • Epworth Sleepiness Scale (ESS) (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    A measure of sleepiness

  • Sleep Log (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Used to record bedtimes, wake times, and naps and will then be reconciled with actigraphy downloads.

  • Stanford Sleepiness Scale (SSS) (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Measure of Alertness at different times during the day.

  • Post Traumatic Stress Disorder (PTSD) Checklist (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Measures response to stressful life experiences.

  • PROMIS Sleep Related Impairment (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Measures sleep impairment

  • PROMIS Sleep Disturbance (CBT-I, Johrei therapy) [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    Measures sleep disturbance

  • Rand 36 Item SF Health Survey Instrument (CBT-I, Johrei therapy) [ Time Frame: 6 weeks ]
    Measures general health.

  • Cytokines and Neurotransmitters (CBT-I, Johrei therapy) [ Time Frame: Baseline, 6 weeks ]
    Measures circulating levels of cytokines and neurotransmitters through blood and urine collection.


Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Johrei Therapy
  • 3 sessions per week lasting 30 minutes.
  • Daily report of bedtime and wake time.

Baseline:

  • Polysomnography
  • Actigraphy
  • Questionnaires
  • Blood draw
  • Urine collection

    2 weeks:

  • Questionnaires
  • Actigraphy download
  • Sleep log reconciliation

    6 weeks:

  • Polysomnography
  • Actigraphy download
  • sleep log reconciliation
  • Questionnaires
  • Blood draw
  • Urine collection
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.
Active Comparator: Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • 1 session per week for a total of 6 weeks with the option of 2 additional sessions.
  • Daily report of bedtime and wake time.

Baseline:

  • Polysomnography
  • Actigraphy
  • Questionnaires
  • Blood draw
  • Urine collection

    2 weeks:

  • Questionnaires
  • Actigraphy download
  • Sleep log reconciliation

    6 weeks:

  • Polysomnography
  • Actigraphy download
  • sleep log reconciliation
  • Questionnaires
  • Blood draw
  • Urine collection
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical and surgical patients with recent critical illness warranting ICU stay.

Exclusion Criteria:

  • Patients who are considered too unstable to undergo this investigation by their primary physician
  • Patients with severe debilitating neurological disease ( end-stage Alzheimer's, large stroke, or other debilitating neurological disease) that renders patients incapable of providing informed consent
  • Pregnancy (All inpatients with recent ICU stay of the childbearing age would have had a pregnancy test while in the hospital).
  • Patient's residence is beyond a 20 mile radius from University of Arizona.
  • Patient does not have a reliable way of communication such as a cellphone or telephone line.
  • Being discharged to a nursing home of skilled nursing facility.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059421

Locations
United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
The Johrei Institute
Investigators
Principal Investigator: Sairam Parthasarathy, MD University of Arizona
  More Information

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02059421     History of Changes
Other Study ID Numbers: 8674
The Johrei Institute ( Other Identifier: Johrei Institute )
Study First Received: February 6, 2014
Last Updated: May 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD information.

Keywords provided by University of Arizona:
Johrei therapy
Sleep
CBT-I
Critical illness

Additional relevant MeSH terms:
Critical Illness
Dyssomnias
Sleep Wake Disorders
Parasomnias
Disease Attributes
Pathologic Processes
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017