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

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ClinicalTrials.gov Identifier: NCT03268629
Recruitment Status : Unknown
Verified October 2018 by Chen Pan, Central South University.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Chen Pan, Central South University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Mindfulness-Based Joyful Sleep Behavioral: CBT-I Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness-Based Joyful Sleep
The proposed 'Joyful Sleep' program will be conducted weekly, 2 hours per session, 8 sessions, group-based in mindfulness. The content and skills are based upon MBSR, MAPs and Tai Chi. The proposed topics include: 1) mindfulness and insomnia, 2) mindful awareness of stress, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, 6) moving mindfulness meditation: the first taste of Tai Chi, 7) moving mindfulness meditation: the second taste of Tai Chi, 8) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, body scan meditation, sitting meditation, standing meditation, walking meditation, Taichi, and daily life meditation.
 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.
Other Name: Mindfulness based intervention for insomnia
Active Comparator: CBT-I
The CBT-I is a weekly, 2-hour, 8 session, group-based program. CBT-I includes 4 central components: stimulus control, sleep restriction, relaxation training and cognitive therapy. The aim of CBT-I is to reduce sleep-related physiologic and cognitive arousal so that restorative sleep function can be re-established.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. change of sleep quality [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)


Secondary Outcome Measures :
  1. change of perceived stress [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    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).

  2. change of anxiety [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    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.

  3. change of depression [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    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).

  4. change of nuclear factor-κB (NF-κB) [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    NF-κB (nuclear factor-κB) 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-κB 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-κB is clearly one of the most important regulators of proinflammatory gene expression.

  5. change of sleep quantity [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    sleep quantity will be measured with Polysomnography (PSG).

  6. change of severity of Insomnia Symptoms (ISI) [ Time Frame: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268629


Contacts
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Contact: Pan Chen, M.D.，Ph.D. 86-13357319516 758933968@qq.com

Locations
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China, Hunan
Thrid Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Central South University
Investigators
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Principal Investigator: Pan Chen, M.D.，Ph.D. Central South University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chen Pan, Principal Investigator, Central South University
ClinicalTrials.gov Identifier: NCT03268629    
Other Study ID Numbers: 2018-S236
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data of participants' assessment result on PSG, Sleep Diary, PSQI, ISS, CPSS, BDI, STAI, NF-κB during intervention will be shared with other researchers through published articles.
Supporting Materials: Study Protocol
Time Frame: data will be made available within 6 months of study completion and no time limitation.
Access Criteria: the data will become available on the database which includes the journal publishing the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chen Pan, Central South University:
Insomnia
Mindfulness-based Intervention
Mindfulness Meditation
 Tai Chi
Inflammation
NF-κB
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders