'Mindfulness-Based Joyful Sleep' Intervention in Young and Middle-aged Individuals With Insomnia

October 5, 2018 updated by: Chen Pan, Central South University

The Efficacy of a Mindfulness-Based Intervention for Insomnia ('Mindfulness-Based Joyful Sleep') in Young and Middle-aged Individuals With Insomnia in China: Study Protocol of a Randomized Controlled Trial

The primary objective of this proposed three-year (June 01, 2018 to May 31,2020) project is to verify the effect of 'Mindfulness Based Joyful Sleep' (MBJS) intervention on young and middle-aged individuals with insomnia in China and preliminarily explore inflammatory response for the intervention of insomnia applied by it. Previous researches show that Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that MBJS will be an effective, feasible and affordable insomnia intervention program in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background：Insomnia is a public health problem attracting extensive attention. Due to the risks of side effect and drug dependence from the drug treatment of insomnia, the non-drug treatment has gradually drawn the attention of clinician. In recent years, Mindfulness-Based Interventions originating from the Eastern culture has created a trend in the application and research of psychological and physical health fields in western countries, and been found to be capable of effectively curing or alleviating many psychosomatic diseases and possibly results in the reversion of gene operation mode and the reduction of inflammation risk. Researches show that Mindfulness-Based Interventions may relieve insomnia, but existing research samples and strict randomized controlled trial are insufficient and its application mechanism is full of uncertainty. In China, empirical research strictly designed is even scarce in such field. At the earlier stage, investigators have designed a intervention scheme for insomnia intervention ('Mindfulness-Based Joyful Sleep') with mindfulness-based meditation and Tai Chi as core technology, and in combination with Chinese culture and have made preliminary application.

Objectives：This study is expected to verify the effect of 'Mindfulness-Based Joyful Sleep' program on young and middle-aged patients with insomnia in China and preliminarily explore the genetic level inflammation mechanism for the intervention of insomnia applied by it.

Methods: Investigators will conduct a 2-arm randomized controlled trial to evaluate the efficacy of mindfulness-based intervention for insomnia ('Mindfulness-Based Joyful sleep'). Patients with insomnia at the age of 18-59 in China will be recruited for this study.The two steps to be implemented include: 1) conducting a pilot study to finalize the design of 'Mindfulness-Based Joyful sleep'program and evaluate the feasibility, acceptability and preliminary outcomes of the'Mindfulness-Based Joyful sleep' program: The final sample is expected to include18 patients who meet inclusion criteria. Participants will receive 8-week 'Mindfulness-Based Joyful sleep' intervention. The efficacy of 'Mindfulness-Based Joyful sleep' program will be assessed by PSQI, and feasibility and acceptability of 'Joyful Sleep' program will be examined by attendance, completion of homework and feedback of participants on the feeling of the program collected by a focus group. 2) conducting a randomized controlled trial to evaluate the efficacy of ''Mindfulness-Based Joyful sleep'' program: The final sample is expected to include 70 patients who meet inclusion criteria. Participants will be randomly assigned to one of 2 groups, receiving'Mindfulness-Based Joyful sleep'intervention, or receiving 'Cognitive Behavior Therapy for insomnia (CBT-I)'. Participants will be assessed at 3 time points by PSG, Sleep Diary, self-reported measures including PSQI, ISI, CPSS, BDI, STAI and bio-indicator (NF-κB) at baseline, the end of the Intervention Period, and at a 3-month follow-up.

Implications: This proposed study has important implications in providing valuable insights into bridging the gap between need and services received for insomnia interventions in China. If the 'Mindfulness-Based Joyful Sleep' Intervention can be used effectively, it can also be popularized to many other patients with insomnia in China in future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Pan Chen, M.D.，Ph.D.
  • Phone Number: 86-13357319516
  • Email: 758933968@qq.com

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Thrid Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged between 18 and 59 years
  2. Diagnosis of insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-V)
  3. Fully conscious
  4. Junior high school or higher education degree
  5. No language impairment or communication disorders
  6. Willing to participate in the study

Exclusion Criteria:

  1. Cognitive impairment
  2. Somatic disorders, including but not limited to cardiovascular disease, cerebrovascular diseases, endocrine diseases, autoimmune diseases, and tumors
  3. Mental disorders, including but not limited to schizophrenia, mood disorders, anxiety disorders, trauma and stress related disorders, substance related disorders
  4. Pregnant or lactating women
  5. Currently taking any prescribed medication
  6. Currently participating in any mindfulness practice for 15 minutes per day (e.g. yoga, Tai Chi, qigong, meditation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-Based Joyful Sleep
The proposed 'Joyful Sleep' program will be conducted weekly, 2 hours per session, 8 sessions, group-based in mindfulness. The content and skills are based upon MBSR, MAPs and Tai Chi. The proposed topics include: 1) mindfulness and insomnia, 2) mindful awareness of stress, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, 6) moving mindfulness meditation: the first taste of Tai Chi, 7) moving mindfulness meditation: the second taste of Tai Chi, 8) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, body scan meditation, sitting meditation, standing meditation, walking meditation, Taichi, and daily life meditation.
Behavioral: Mindfulness-Based Joyful Sleep
The proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.
Other Names:
  • Mindfulness based intervention for insomnia
Active Comparator: CBT-I
The CBT-I is a weekly, 2-hour, 8 session, group-based program. CBT-I includes 4 central components: stimulus control, sleep restriction, relaxation training and cognitive therapy. The aim of CBT-I is to reduce sleep-related physiologic and cognitive arousal so that restorative sleep function can be re-established.
Behavioral: CBT-I
The CBT-I program was delivered to groups of 10-15 individuals over the course of eight, weekly, 2-hour sessions, for a total of 16 contact hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of sleep quality
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change of perceived stress
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Perceived stress will be assessed by Perceived Stress Scale (PSS). The PSS has 14 items. Items are rated on a 5-point Likert-type scale, with higher total scores indicating higher perceived stress (0-13, low perceived stress; 14-26, moderate perceived stress; 27-40, high perceived stress).
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
change of anxiety
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Anxiety will be assessed by State-Trait Anxiety Inventory (STAI). The STAI has 20 items for assessing trait anxiety (TAI) and 20 items for assessing state anxiety (SAI). All items are rated on a 4-point scale, with higher total scores indicate greater anxiety.
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
change of depression
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Depression will be assessed by Beck Depression Inventory (BDI). The BDI consists of 21 items. All items are rated on a 4-point scale, with higher total scores indicating more severe depression (31-40 indicates severe depressive symptoms and scores > 40 indicate extreme depressive symptoms).
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
change of nuclear factor-κB (NF-κB)
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
NF-κB (nuclear factor-κB) is a collective name for inducible dimeric transcription factors composed of members of the Rel family of DNA-binding proteins that recognize a common sequence motif. NF-κB is found in essentially all cell types and is involved in activation of an exceptionally large number of genes in response to infections, inflammation, and other stressful situations requiring rapid reprogramming of gene expression. NF-κB is clearly one of the most important regulators of proinflammatory gene expression.
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
change of sleep quantity
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
sleep quantity will be measured with Polysomnography (PSG).
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
change of severity of Insomnia Symptoms (ISI)
Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Severity of Insomnia Symptoms will be measured with Insomnia Severity Index (ISI). The ISI comprises 7 items, which are each rated on a five-point scale. Total scores range from zero to 28. ISI clinical cut points are categorized as: no insomnia (zero to seven), subthreshold insomnia (eight to 14), moderate insomnia (15-21), and severe insomnia (22-28).
Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pan Chen, M.D.，Ph.D., Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-S236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data of participants' assessment result on PSG, Sleep Diary, PSQI, ISS, CPSS, BDI, STAI, NF-κB during intervention will be shared with other researchers through published articles.

IPD Sharing Time Frame

data will be made available within 6 months of study completion and no time limitation.

IPD Sharing Access Criteria

the data will become available on the database which includes the journal publishing the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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