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

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059421 on ClinicalTrials.gov