Insomnia, PrimaryNCT04806009
Evaluating an Online Mindfulness-Based Intervention for Insomnia
A study testing 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program and 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program in people with Insomnia, Primary, run by Central South University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Insomnia, Primary
- What is being tested?
- 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program and 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 59 years old
- Being able to read and write Chinese
- PSQI exceeding 5 at screening
- Being able to access online services
- Willing to participate in the study
Who cannot join
- Unable to communicate
- With somatic disorders
- With mental disorders except for insomnia disorder
- Being treated with pharmacotherapy
- Significant current mindfulness practices (>15 minutes/ day)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia, Primary
- Being tested
- 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program, 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program
- Keywords
- insomnia, mindfulness-based intervention, Cognitive Behavioral Therapy for insomnia, online
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-programBehavioural
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.
'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program | Experimental | 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. Receives: Behavioral: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program |
| 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program | Active comparator | 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. Receives: Behavioral: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of sleep quality
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.
Measured: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary outcomes (6)
change of perceived stress
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).
Measured: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of depression
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.
Measured: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of mindfulness
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.
Measured: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of anxiety
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.
Measured: 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
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.
Measured: 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
Digital biomarker data such as sleep duration and quality, and daytime activity will be assessed by Mi Wristband.
Measured: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Pan, Central South University
- Investigators
- Chen Pan, Dr, Principal investigator, The Third Xiangya Hospital,Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806009
- Sponsor's protocol ID
- CentralSouthU2021
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan C, Tie B, Yuwen W, Su X, Deng Y, Ma X, Wu Y, Liao Y, Kong L, Zhang Y, Li Z, Pan Q, Tang Q. 'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial. BMJ Open. 2022 Feb 15;12(2):e053501. doi: 10.1136/bmjopen-2021-053501.
PubMed 35168972
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating an Online Mindfulness-Based Intervention for Individuals With Insomnia in China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04806009
- Acronym / sponsor ID
- CentralSouthU2021
- Conditions
- Insomnia, Primary
- Keywords
- insomnia, mindfulness-based intervention, Cognitive Behavioral Therapy for insomnia, online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program | Experimental | Behavioral: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-programParticipants 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. |
| 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program | Active comparator | Behavioral: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-programParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 59 years old
- Being able to read and write Chinese
- PSQI exceeding 5 at screening
- Being able to access online services
- Willing to participate in the study
Key exclusion criteria (5 listed)
- Unable to communicate
- With somatic disorders
- With mental disorders except for insomnia disorder
- Being treated with pharmacotherapy
- Significant current mindfulness practices (>15 minutes/ day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-programThe 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. | Behavioural | 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program |
| 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-programThe 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. | Behavioural | 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 35168972Pan C, Tie B, Yuwen W, Su X, Deng Y, Ma X, Wu Y, Liao Y, Kong L, Zhang Y, Li Z, Pan Q, Tang Q. 'Mindfulness Living with Insomnia': an mHealth intervention for individuals with insomnia in China: a study protocol of a randomised controlled trial. BMJ Open. 2022 Feb 15;12(2):e053501. doi: 10.1136/bmjopen-2021-053501.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Pan, Dr principal investigator
The Third Xiangya Hospital,Central South University
Questions about this trial
What is this clinical trial studying?
A study testing 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program and 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program in people with Insomnia, Primary, run by Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Pan, Dr (86-0731-88618487, 758933968@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.