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

NCT03268629 | Unknown

• 1 other identifier: 2018-S236
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Mindfulness-based Intervention; Mindfulness Meditation; Tai Chi; Inflammation; NF-κB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• change of perceived stress

  Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

• change of anxiety

  Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

• change of depression

  Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

• change of nuclear factor-κB (NF-κB)

  Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

• change of sleep quantity

  Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up

Study Arms (2)

Mindfulness-Based Joyful Sleep

EXPERIMENTAL

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

CBT-I

ACTIVE COMPARATOR

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

Interventions

Mindfulness-Based Joyful Sleep BEHAVIORAL

The proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.

Also known as: Mindfulness based intervention for insomnia

Mindfulness-Based Joyful Sleep

CBT-I BEHAVIORAL

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.

CBT-I

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Thrid Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• 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.

  PMID: 31296508 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Inflammation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pan Chen, M.D.，Ph.D.

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pan Chen, M.D.，Ph.D.

CONTACT

86-13357319516; 758933968@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: August 31, 2017
• Study Start: December 1, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

CN (1)