A guided internet-delivered mindfulness-based cognitive therapy for insomnia: study protocol for a randomized controlled study.
Zixuan Zeng, Fei Liu, Chenyi Zhu, Xiangyun Long, Jiahui Jiang, Lei Huang, Zheng Lu
Frontiers in Psychiatry 2025 DOI: 10.3389/fpsyt.2025.1506183 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 80 |
| Population | Chinese adults with chronic insomnia disorder |
| Intervention | Sleep hygiene education (SHE) |
| Duration | 8-week intervention, 20-week follow-up |
| Topics | Meditation |
| Keywords | Internet-based intervention Cognitive behavioral therapy Randomized controlled trial Insomnia treatment Clinical trials Digital health therapy Mindfulness-based cbt Sleep research |
| Citations | 1 |
| Key findings | This is a study protocol; no results are reported yet. |
Abstract
Chronic insomnia disorder (CID) is highly prevalent and impacts individuals' physiological, psychological and social functions. Although cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment option for CID, approximately 20% of patients still exhibit limited effectiveness. The literature has shown that mindfulness can benefit CBT-I protocols and that mindfulness-based cognitive therapy (MBCT) is effective in treating insomnia. However, the effectiveness of therapist-guided internet-based MBCT-I (iMBCT-I) has not yet been tested. This study protocol aims to evaluate the effect of therapist-guided iMBCT-I on chronic insomnia among Chinese adults. This will be a two-armed, parallel group, randomized controlled study with 80 CID patients. The participants will be randomized to either the iMBCT-I program or the sleep hygiene education (SHE) program at an allocation ratio of 1:1 via simple randomization. Assessments will be carried out at baseline, at the end of the intervention (week 8) and at the follow-up time (week 20). The primary outcome was insomnia severity at week 8. Statistical analyses will follow the intention-to-treat (ITT) principle. This is the first study to investigate the effectiveness of therapist-guided iMBCT-I in CID patients. Should it be effective, this study will provide evidence for clinical practitioners, therapists and patients to consider a new psychotherapeutic option and for technicians to perform self-guided iMBCT-I applications in the future. https://www.chictr.org.cn, identifier ChiCTR240008430.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 12
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Journal of Consulting and Clinical Psychology 2000
- The effect of mindfulness meditation on sleep quality: a systematic review and meta‐analysis of randomized controlled trials Annals of the New York Academy of Sciences December 21, 2018
- Mindfulness Meditation and Improvement in Sleep Quality and Daytime Impairment Among Older Adults With Sleep Disturbances JAMA Internal Medicine February 16, 2015
- Mindfulness-based cognitive therapy improves insomnia symptoms in individuals with recurrent depression: secondary analyses from a randomized controlled trial. Frontiers in Psychiatry 2023
and 7 more in the library