InsomniaNCT03268629
'Mindfulness-Based Joyful Sleep' Intervention in Young and Middle-aged Individuals With Insomnia
A study testing Mindfulness-Based Joyful Sleep and CBT-I in people with Insomnia, run by Central South University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness-Based Joyful Sleep and CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Thrid Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
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
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Mindfulness-Based Joyful Sleep, CBT-I
- Keywords
- Insomnia, Mindfulness-based Intervention, Mindfulness Meditation, Tai Chi, Inflammation, NF-κB
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Joyful SleepBehavioural
Also called Mindfulness based intervention for insomnia
The proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness.
CBT-IBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of sleep quality
Sleep quality will be measured with Pittsburgh Sleep Quality Index (PSQI)
Measured: 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
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).
Measured: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
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.
Measured: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
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).
Measured: 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)
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.
Measured: 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
sleep quantity will be measured with Polysomnography (PSG).
Measured: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
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).
Measured: Outcomes will be evaluated at baseline, the end of the 8-week Intervention Period, and at a 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Dec 2018 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Pan, Central South University
- Investigators
- Pan Chen, M.D.，Ph.D., Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268629
- Sponsor's protocol ID
- 2018-S236
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31296508
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03268629
- Acronym / sponsor ID
- 2018-S236
- Conditions
- Insomnia
- Keywords
- Insomnia, Mindfulness-based Intervention, Mindfulness Meditation, Tai Chi, Inflammation, NF-κB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Joyful Sleep | Experimental | Behavioral: Mindfulness-Based Joyful SleepThe 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. |
| CBT-I | Active comparator | Behavioral: CBT-IThe 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Joyful SleepAlso: Mindfulness based intervention for insomniaThe proposed "Mindfulness-Based Joyful Sleep" program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness. | Behavioural | Mindfulness-Based Joyful Sleep |
| CBT-IThe 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. | Behavioural | CBT-I |
Primary outcome
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)
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31296508Pan 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Insomnia
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pan Chen, M.D.，Ph.D. principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Joyful Sleep and CBT-I in people with Insomnia, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pan Chen, M.D.，Ph.D. (86-13357319516, 758933968@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.