Evaluating an Online Mindfulness-Based Intervention for Insomnia

Central South University

Status: Unknown

Conditions: Insomnia, Primary

Treatments: Behavioral: 'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program; Behavioral: 'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program

Study type: Interventional

Funder types: Other

Identifiers

NCT04806009

CentralSouthU2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

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

Active Comparator group

Description:

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.

Treatment:

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