Evaluating an Online Mindfulness-Based Intervention for Insomnia

Insomnia, Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04806009
• Other study ID #: CentralSouthU2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2021
• Source: Central South University
• Contact: Chen Pan, Dr
• Phone: 86-0731-88618487
• Email: 758933968[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia, Primary
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• '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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary	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.	Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary	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.	Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary	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.	Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary	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.	Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
Secondary	change of sleep duration and quality	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