Clinical trial NCT03268629: 'Mindfulness-Based Joyful Sleep' Intervention in Young and Middle-aged Individuals With Insomnia
Official title: The Efficacy of a Mindfulness-Based Intervention for Insomnia ('Mindfulness-Based Joyful Sleep') in Young and Middle-aged Individuals With Insomnia in China: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Mindfulness-based Intervention
Mindfulness Meditation
Tai Chi
Inflammation
NF-κB
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this proposed three-year (June 01, 2018 to May 31,2020) project is to verify the effect of 'Mindfulness Based Joyful Sleep' (MBJS) intervention on young and middle-aged individuals with insomnia in China and preliminarily explore inflammatory response for the intervention of insomnia applied by it. Previous researches show that Mindfulness-Based Interventions may relieve insomnia, it is hypothesized that MBJS will be an effective, feasible and affordable insomnia intervention program in China.

Detailed description: Background：Insomnia is a public health problem attracting extensive attention. Due to the risks of side effect and drug dependence from the drug treatment of insomnia, the non-drug treatment has gradually drawn the attention of clinician. In recent years, Mindfulness-Based Interventions originating from the Eastern culture has created a trend in the application and research of psychological and physical health fields in western countries, and been found to be capable of effectively curing or alleviating many psychosomatic diseases and possibly results in the reversion of gene operation mode and the reduction of inflammation risk. Researches show that Mindfulness-Based Interventions may relieve insomnia, but existing research samples and strict randomized controlled trial are insufficient and its application mechanism is full of uncertainty. In China, empirical research strictly designed is even scarce in such field. At the earlier stage, investigators have designed a intervention scheme for insomnia intervention ('Mindfulness-Based Joyful Sleep') with mindfulness-based meditation and Tai Chi as core technology, and in combination with Chinese culture and have made preliminary application.

Objectives：This study is expected to verify the effect of 'Mindfulness-Based Joyful Sleep' program on young and middle-aged patients with insomnia in China and preliminarily explore the genetic level inflammation mechanism for the intervention of insomnia applied by it.

Methods: Investigators will conduct a 2-arm randomized controlled trial to evaluate the efficacy of mindfulness-based intervention for insomnia ('Mindfulness-Based Joyful sleep'). Patients with insomnia at the age of 18-59 in China will be recruited for this study.The two steps to be implemented include: 1) conducting a pilot study to finalize the design of 'Mindfulness-Based Joyful sleep'program and evaluate the feasibility, acceptability and preliminary outcomes of the'Mindfulness-Based Joyful sleep' program: The final sample is expected to include18 patients who meet inclusion criteria. Participants will receive 8-week 'Mindfulness-Based Joyful sleep' intervention. The efficacy of 'Mindfulness-Based Joyful sleep' program will be assessed by PSQI, and feasibility and acceptability of 'Joyful Sleep' program will be examined by attendance, completion of homework and feedback of participants on the feeling of the program collected by a focus group. 2) conducting a randomized controlled trial to evaluate the efficacy of ''Mindfulness-Based Joyful sleep'' program: The final sample is expected to include 70 patients who meet inclusion criteria. Participants will be randomly assigned to one of 2 groups, receiving'Mindfulness-Based Joyful sleep'intervention, or receiving 'Cognitive Behavior Therapy for insomnia (CBT-I)'. Participants will be assessed at 3 time points by PSG, Sleep Diary, self-reported measures including PSQI, ISI, CPSS, BDI, STAI and bio-indicator (NF-κB) at baseline, the end of the Intervention Period, and at a 3-month follow-up.

Implications: This proposed study has important implications in providing valuable insights into bridging the gap between need and services received for insomnia interventions in China. If the 'Mindfulness-Based Joyful Sleep' Intervention can be used effectively, it can also be popularized to many other patients with insomnia in China in future.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 59 years
2. Diagnosis of insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th ed (DSM-V)
3. Fully conscious
4. Junior high school or higher education degree
5. No language impairment or communication disorders
6. Willing to participate in the study

Exclusion Criteria:

1. Cognitive impairment
2. Somatic disorders, including but not limited to cardiovascular disease, cerebrovascular diseases, endocrine diseases, autoimmune diseases, and tumors
3. Mental disorders, including but not limited to schizophrenia, mood disorders, anxiety disorders, trauma and stress related disorders, substance related disorders
4. Pregnant or lactating women
5. Currently taking any prescribed medication
6. Currently participating in any mindfulness practice for 15 minutes per day (e.g. yoga, Tai Chi, qigong, meditation)

Primary outcomes:
measure: change of sleep quality
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Secondary outcomes:
measure: change of perceived stress
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
measure: change of anxiety
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
measure: change of depression
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
measure: change of nuclear factor-κB (NF-κB)
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
measure: change of sleep quantity
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
measure: change of severity of Insomnia Symptoms (ISI)
timeFrame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Other outcomes:
Locations:
city: Changsha
country: China
facility: Thrid Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Pan Chen, M.D.，Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan C, Wang X, Deng Y, Li P, Liao Y, Ma X, Yang GP, Dai L, Tang Q. Efficacy of mindfulness-based intervention ('mindfulness-based joyful sleep') in young and middle-aged individuals with insomnia using a biomarker of inflammatory responses: a prospective protocol of a randomised controlled trial in China. BMJ Open. 2019 Jul 10;9(7):e027061. doi: 10.1136/bmjopen-2018-027061.