Evaluating an Online Mindfulness-Based Intervention for Insomnia

Not Applicable

• Conditions: Insomnia, Primary
• Interventions: Behavioral: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program; Behavioral: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program

• Registration Number: NCT04806009
• Lead Sponsor: Central South University

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program	'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.
'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program	'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.

Primary Outcome Measures

Name	Time	Method
change of sleep quality	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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).
change of mindfulness	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.
change of sleep duration and quality	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.
change of depression	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.
change of anxiety	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.