Clinical trial NCT04806009: Evaluating an Online Mindfulness-Based Intervention for Insomnia
Official title: Evaluating an Online Mindfulness-Based Intervention for Individuals With Insomnia in China: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia, Primary
Keywords: insomnia
mindfulness-based intervention
Cognitive Behavioral Therapy for insomnia
online
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: change of sleep quality
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary outcomes:
measure: change of perceived stress
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
measure: change of depression
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
measure: change of mindfulness
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
measure: change of anxiety
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
measure: change of severity of insomnia symptoms
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
measure: change of sleep duration and quality
timeFrame: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: The Third Xiangya Hospital,Central South University
name: Chen Pan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.