Evaluating an Online Mindfulness-Based Intervention for Insomnia

March 17, 2021 updated by: Chen Pan, Central South University

Evaluating an Online Mindfulness-Based Intervention for Individuals With Insomnia in China: A Randomized Controlled Trial

Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

This will be an online based, randomized, controlled trial. Investigators will recruit 1000 participants, and will randomize and allocate participants 1:1 to the 'Mindful Living With Insomnia (MLWI)' group (n=500) and the 'CBT-I' group (n=500). The Intervention will involve 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. The primary outcome will be sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia symptoms assessed by the Insomnia Severity Index (ISI), and sleep parameters recorded using Mi Smart Band. The secondary outcomes include perceived stress, anxiety, depression, and mindfulness. Outcomes will be evaluated at baseline, the end of the intervention period, and at a 3-month follow-up. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson's correlations will be applied in data analysis.

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.
1000

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.

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. Age between 18 and 59 years old
  2. Being able to read and write Chinese
  3. PSQI exceeding 5 at screening
  4. Being able to access online services
  5. Willing to participate in the study

Exclusion Criteria:

  1. Unable to communicate
  2. With somatic disorders
  3. With mental disorders except for insomnia disorder
  4. Being treated with pharmacotherapy
  5. Significant current mindfulness practices (>15 minutes/ day)

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: Single

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: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program
Participants in the Intervention Group will receive the MLWI Intervention after follow the WeChat mini-program. The MLWI Intervention was developed and presented by the Principle Investigator (PI) who is a psychiatrist and have completed the Training of Mindfulness Facilitation (TMF) program at the Mindful Awareness Research Center of University of California, Los Angeles.
Behavioral: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program
The MLWI Intervention involves 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. Two new sessions of online lessons will be updated weekly in the 6 weeks. Each session is consisted of theoretical lecture, mindfulness practices, sharing common difficulties and coping way during mindfulness practices and homework assignment in the form of video or audio. The Mindfulness practices embedded in the intervention include mindful breathing, mindful body scan, mindful dealing with thoughts and emotions, mindful meditation, mindful movement, and daily life mindfulness. In the intervention, the participants will also receive sleep hygiene education.Participants in the Intervention Group will receive the MLWI Intervention after follow the WeChat mini-program.
Active Comparator: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program
Participants in the Control Group will receive CBT-I after follow the WeChat mini-program. The CBT-I was developed and presented by a researcher who is a psychiatrist/psychologist and have many years' experiences in CBT.
Behavioral: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program
The CBT-I involves 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. Two new sessions of online lessons will be updated weekly in the 6 weeks. Each session is consisted of theoretical lecture, cognitive or behavioral regulation techniques, sharing common difficulties and coping way during mindfulness practices and homework assignment in the form of video or audio.Participants in the Control Group will receive CBT-I after follow the WeChat mini-program.

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 6-week Intervention Period, and at a 3-month follow-up
The 19-item Pittsburgh Sleep Quality Index (PSQI) measured sleep quality subjectively and assesses sleep disturbances during the past month on a 4-point Likert scale of 0 -3.A lower global PSQI score indicates better sleep quality.
Outcomes will be evaluated at baseline, the end of the 6-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 6-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 6-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 6-week Intervention Period, and at a 3-month follow-up
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 consists of 9 items and all items are rated on a 4-point scale (0 = never; 3 = always), with higher total scores indicating more severe depression. Cutoffs are 5, 10, 15, and 20 for mild, moderate, moderately severe, and severe depression, respectively. The standard cut-off score of 10 or greater maximized combined sensitivity and specificity.
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of mindfulness
Time Frame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Mindfulness level will be assessed using Five Facets Mindfulness Questionnaire (FFMQ).FFMQ consists of 39 items which range from 1 (never or very rarely true) to 5 (very often or always true). The higher the total score, the more mindful the individual is.
Outcomes will be evaluated at baseline, the end of the 6-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 6-week Intervention Period, and at a 3-month follow-up
Anxiety will be assessed using the Generalized Anxiety Disorder Questionnaire (GAD-7). The GAD-7 has 7 items for assessing the level of general anxiety.All items are rated on a 4-point scale (0 = never; 3 = always), with higher total scores indicating higher levels of anxiety, and a cutoff score >6 is recommended to identify anxiety symptoms.
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of severity of insomnia symptoms
Time Frame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
The 7-item ISI assesses the current severity of insomnia symptoms, sleep dissatisfaction, daytime impacts, and distress concerning difficulties with sleep on a 5-point Likert scale (0 = never; 4 = always). Total scores range from 0 to 28. Cutoffs are 8, 15, 22 for subthreshold, moderate and severe insomnia respectively.
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of sleep duration and quality
Time Frame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Digital biomarker data such as sleep duration and quality, and daytime activity will be assessed by Mi Wristband.
Outcomes will be evaluated at baseline, the end of the 6-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: Chen Pan, Dr, The Third Xiangya Hospital,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.
January 1, 2022

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.
December 31, 2022

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.
March 31, 2023

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).
March 7, 2021

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.
March 17, 2021

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.
March 19, 2021

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.
March 19, 2021

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.
March 17, 2021

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.
March 1, 2021

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.
  • CentralSouthU2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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