Evaluating an Online Mindfulness-Based Intervention for Insomnia

NCT ID: NCT04806009

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-03-31

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.

Conditions

Insomnia, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

'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.

Group Type: EXPERIMENTAL

'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program

Intervention Type: BEHAVIORAL

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.

Interventions

'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.

Intervention Type: BEHAVIORAL

'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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Chen Pan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Pan, Dr

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital,Central South University

Central Contacts

Chen Pan, Dr

Role: CONTACT

758933968@qq.com

86-0731-88618487

References

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.

Reference Type: DERIVED

PMID: 35168972 (View on PubMed)

Other Identifiers

CentralSouthU2021

Identifier Type: -

Identifier Source: org_study_id