Evaluating an Online Mindfulness-Based Intervention for Insomnia
1 other identifier
interventional
1,000
0 countries
N/A
Brief 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. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMarch 19, 2021
March 1, 2021
12 months
March 7, 2021
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of depression
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of mindfulness
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
change of anxiety
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
Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
- +1 more secondary outcomes
Study Arms (2)
'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to communicate
- With somatic disorders
- With mental disorders except for insomnia disorder
- Being treated with pharmacotherapy
- Significant current mindfulness practices (\>15 minutes/ day)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35168972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Pan, Dr
The Third Xiangya Hospital,Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2021
First Posted
March 19, 2021
Study Start
January 1, 2022
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
March 19, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share