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

NCT02059421 | Completed DMC

• 2 other identifiers: 8674The Johrei Institute
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Johrei therapy; Sleep; CBT-I; Critical illness

Outcome Measures

Primary Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI) (CBT-I, Johrei therapy)

  Used to measure sleep quality

  2 weeks

• Polysomnography (CBT-I, Johrei therapy)

  Used to measure sleep efficiency

  6 weeks

• Pittsburgh Sleep Quality Index (PSQI) (CBT-I, Johrei therapy)

  Used to measure sleep quality.

  6 weeks

Secondary Outcomes (9)

• Actigraphy (CBT-I, Johrei therapy)

  Baseline, 2 weeks, 6 weeks

• Epworth Sleepiness Scale (ESS) (CBT-I, Johrei therapy)

  Baseline, 2 weeks, 6 weeks

• Sleep Log (CBT-I, Johrei therapy)

  Baseline, 2 weeks, 6 weeks

• Stanford Sleepiness Scale (SSS) (CBT-I, Johrei therapy)

  Baseline, 2 weeks, 6 weeks

• Post Traumatic Stress Disorder (PTSD) Checklist (CBT-I, Johrei therapy)

  Baseline, 2 weeks, 6 weeks

Study Arms (2)

Johrei Therapy

EXPERIMENTAL

* 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

Cognitive Behavioral Therapy for Insomnia (CBT-I)

ACTIVE COMPARATOR

* 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)

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

\- 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

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Johrei therapy OTHER

* 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.

Johrei Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• The Johrei Institute: collaborator

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Buzzetti RA, Hinojosa-Kurtzberg M, Shea TJ, Ibuki Y, Sirakis G, Parthasarathy S. Effect of Johrei therapy on sleep in a murine model. Explore (NY). 2013 Mar-Apr;9(2):100-5. doi: 10.1016/j.explore.2012.12.004.

  PMID: 23452712 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 11, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)