'Mindfulness-Based Joyful Sleep' Intervention in Young and Middle-aged Individuals With Insomnia

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03268629
• Other study ID #: 2018-S236
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2018
• Source: Central South University
• Contact: Pan Chen, M.D.,Ph.D.
• Phone: 86-13357319516
• Email: 758933968[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Mindfulness-Based Joyful Sleep
The proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.
• CBT-I
The CBT-I program was delivered to groups of 10-15 individuals over the course of eight, weekly, 2-hour sessions, for a total of 16 contact hours.

Locations

Country	Name	City	State
China	Thrid Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of sleep quality	Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)	Outcomes will be evaluated at baseline, the end of the 8-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 8-week Intervention Period, and at a 3-month follow-up
Secondary	change of anxiety	Anxiety will be assessed by State-Trait Anxiety Inventory (STAI). The STAI has 20 items for assessing trait anxiety (TAI) and 20 items for assessing state anxiety (SAI). All items are rated on a 4-point scale, with higher total scores indicate greater anxiety.	Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Secondary	change of depression	Depression will be assessed by Beck Depression Inventory (BDI). The BDI consists of 21 items. All items are rated on a 4-point scale, with higher total scores indicating more severe depression (31-40 indicates severe depressive symptoms and scores > 40 indicate extreme depressive symptoms).	Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Secondary	change of nuclear factor-?B (NF-?B)	NF-?B (nuclear factor-?B) is a collective name for inducible dimeric transcription factors composed of members of the Rel family of DNA-binding proteins that recognize a common sequence motif. NF-?B is found in essentially all cell types and is involved in activation of an exceptionally large number of genes in response to infections, inflammation, and other stressful situations requiring rapid reprogramming of gene expression. NF-?B is clearly one of the most important regulators of proinflammatory gene expression.	Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Secondary	change of sleep quantity	sleep quantity will be measured with Polysomnography (PSG).	Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Secondary	change of severity of Insomnia Symptoms (ISI)	Severity of Insomnia Symptoms will be measured with Insomnia Severity Index (ISI). The ISI comprises 7 items, which are each rated on a five-point scale. Total scores range from zero to 28. ISI clinical cut points are categorized as: no insomnia (zero to seven), subthreshold insomnia (eight to 14), moderate insomnia (15-21), and severe insomnia (22-28).	Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up