InsomniaMMINCT03337061
A Trial of Mindfulness Meditation for Chronic Insomnia
A study testing Mindfulness Meditation in people with Insomnia, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people with chronic insomnia and with this the viability of smartphone delivered meditation based approaches at a population level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- Meet the diagnostic criteria for an insomnia disorder. Defined as difficulty initiating or maintaining sleep despite adequate opportunity, with at least one symptom of an associated daytime impairment. Additional quantitative insomnia criteria following research recommendations include frequency (defined as sleep onset latency (SOL) or wake after sleep onset (WASO) > 30 minutes at least 3 nights per week and for chronicity, defined as symptoms lasting > 6 months.
- Have access to an iOS or Android smartphone or a desktop computer with Internet access
- Participants will be required to sign an informed consent form
Who cannot join
- Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
- Uncontrolled psychiatric conditions requiring immediate treatment outside of the study, including current major depressive episode
- Comorbid sleep disorders including obstructive sleep apnea
- Current use of hypnotic or sedating medications for the purpose of insomnia
- Inadequate proficiency in English to complete the protocol
- Participation in other trials concurrently
- Regular meditation practice defined as equal to or more than 2x weekly for the past 30 days
About this study
To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people with chronic insomnia and with this the viability of smartphone delivered meditation based approaches at a population level.
Read the detailed description
Sleep complaints are amongst the commonest in medical practice, and insomnia, the commonest of these affecting transiently 1/3 of the population at some point in the year and 1/3 of this population that is 1 in 10 persisting as chronic insomnia. There are significant consequences on the quality of life for individuals and significant economic burden for society.
Insomnia disorder is characterized as persistent difficulty in falling or staying asleep with resulting daytime dysfunction. Once physical and psychiatric causes have been excluded, current treatment guidelines include pharmacological and behavioural approaches. Hypnotic therapy will reduce sleep latency and increase total sleep time, but there are concerns about drug dependency and side effects (residual day time sleepiness and road traffic accidents and impaired balance). Behavioural treatment (CBTi) has been shown to be effective, but availability is scarce and less than 50% of patients achieve full remission, making alternative approaches desirable.
To optimize availability and to improve outcomes, approaches have included group sessions, single treatment sessions and internet sessions, but these are still limited in the NHS by availability of resources or by expense. Mindfulness meditation, focused non-judgmental awareness and attention on the present moment experience, can promote calmness and relaxation. Several health benefits have been shown across stress related conditions, including sleep disturbance, and its universal availability and ease of application make it an attractive alternative to conventional CBTi.
A randomized controlled trial compared Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Therapy for Insomnia (MBTI), and Self-monitoring (SM) in the treatment of chronic insomnia . Results indicate that those receiving mindfulness-based interventions (MBSR or MBTI) had significant reductions in total wake time and pre-sleep arousal from baseline-to-post compared to SM. The study concluded that mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia.
A recent meta-analysis of 6 randomised controlled trials demonstrated that mindfulness meditation may contribute to improving sleep in subjects with insomnia compared to a control group. Specifically, mindfulness meditation was found to significantly reduce total wake time, sleep onset latency and sleep quality .
The present study builds upon this work, using a small-scale randomized controlled trial to gather preliminary evidence for the treatment efficacy of a brief mindfulness intervention delivered through a mobile application. Headspace (www.headspace.com) mindfulness app will be used to deliver the meditation content. Headspace currently has over 7 million users worldwide and was recently rated in a systematic review as being the highest quality mindfulness app on the market . Participants are adults with insomnia recruited through a sleep centre, recruited for management of their insomnia.
The potential risks of the study are low, as participants will be exposed to a low dose of mindfulness (10 minutes daily). Adverse effects of meditation have been reported in people with a predisposition to psychiatric illness that underwent extensive mindfulness training, such as a 10-day silent retreat. Negative effects have not been reported from 8-week mindfulness interventions. The benefits from this study include improvement in or resolution of insomnia.
- Conditions
- Insomnia
- Being tested
- Mindfulness Meditation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationOther
Mindfulness Meditation delivered through a mobile application
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Mindfulness) | Experimental | This arm will receive mindfulness-based interventions through a mobile application Receives: Other: Mindfulness Meditation |
| Control (Sleep Advice) | No intervention | This is the control arm that will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity (Insomnia Severity Index)
Insomnia Severity Index (ISI): The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. This will be administered at baseline, after 8-weeks and at a 3 and 6-month follow-up. The index will be sent to by post and. It will take approximately 5 minutes to complete.
Measured: 8 weeks, 3 and 6 month follow-up
Change in Actigraphy determined wake time (TWT)
Actigraphy: Sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch during the screening interview conducted at the beginning of the study. The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 2-week screening period. Additionally, the actiwatch will be worn for one week after the 8-week intervention and for one week prior to the 3 and 6-month follow-up. Participants will send the actiwatch to the investigator by post after each measurement period. The actiwatch will be sent to participants by post before the next measurement point; apart from the first time point where the participant will be given the actiwatch.
Measured: 2-week screening, 8-week intervention, 3 and 6-month follow-up
Secondary outcomes (2)
Review of mobile-based mindfulness meditation application for insomnia
Review of use of the mobile application and ascertain it's validity for use within this demographic of patients. The review will be performed using usage of the application by participants over the trial period.
Measured: 6 months
Mindfulness (CAMS-R)
Mindfulness Inventory (CAMS-R): The CAMS-R will be administered at baseline, after 8-weeks and at a 3 and 6-month follow-up. The inventory will be sent to participants by post. It will take approximately 5 minutes to complete.
Measured: Baseline, 8-weeks, 3 and 6-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 posted8 Nov 2017
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: Study never started - halted by funder
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Hart, MD, Study chair, Guys and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337061
- Sponsor's protocol ID
- 174084
- Acronym
- MMI
- Status last verified
- Feb 2020
- First submitted
- 27 Oct 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Mindfulness Meditation for Chronic Insomnia
- ClinicalTrials.gov ID
- NCT03337061
- Acronym / sponsor ID
- MMI / 174084
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started - halted by funder
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 8 Nov 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.
To evaluate the efficacy of mediation therapies on measures of sleep and arousal for people with chronic insomnia and with this the viability of smartphone delivered meditation based approaches at a population level.
Detailed description
Sleep complaints are amongst the commonest in medical practice, and insomnia, the commonest of these affecting transiently 1/3 of the population at some point in the year and 1/3 of this population that is 1 in 10 persisting as chronic insomnia. There are significant consequences on the quality of life for individuals and significant economic burden for society.
Insomnia disorder is characterized as persistent difficulty in falling or staying asleep with resulting daytime dysfunction. Once physical and psychiatric causes have been excluded, current treatment guidelines include pharmacological and behavioural approaches. Hypnotic therapy will reduce sleep latency and increase total sleep time, but there are concerns about drug dependency and side effects (residual day time sleepiness and road traffic accidents and impaired balance). Behavioural treatment (CBTi) has been shown to be effective, but availability is scarce and less than 50% of patients achieve full remission, making alternative approaches desirable.
To optimize availability and to improve outcomes, approaches have included group sessions, single treatment sessions and internet sessions, but these are still limited in the NHS by availability of resources or by expense. Mindfulness meditation, focused non-judgmental awareness and attention on the present moment experience, can promote calmness and relaxation. Several health benefits have been shown across stress related conditions, including sleep disturbance, and its universal availability and ease of application make it an attractive alternative to conventional CBTi.
A randomized controlled trial compared Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Therapy for Insomnia (MBTI), and Self-monitoring (SM) in the treatment of chronic insomnia . Results indicate that those receiving mindfulness-based interventions (MBSR or MBTI) had significant reductions in total wake time and pre-sleep arousal from baseline-to-post compared to SM. The study concluded that mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia.
A recent meta-analysis of 6 randomised controlled trials demonstrated that mindfulness meditation may contribute to improving sleep in subjects with insomnia compared to a control group. Specifically, mindfulness meditation was found to significantly reduce total wake time, sleep onset latency and sleep quality .
The present study builds upon this work, using a small-scale randomized controlled trial to gather preliminary evidence for the treatment efficacy of a brief mindfulness intervention delivered through a mobile application. Headspace (www.headspace.com) mindfulness app will be used to deliver the meditation content. Headspace currently has over 7 million users worldwide and was recently rated in a systematic review as being the highest quality mindfulness app on the market . Participants are adults with insomnia recruited through a sleep centre, recruited for management of their insomnia.
The potential risks of the study are low, as participants will be exposed to a low dose of mindfulness (10 minutes daily). Adverse effects of meditation have been reported in people with a predisposition to psychiatric illness that underwent extensive mindfulness training, such as a 10-day silent retreat. Negative effects have not been reported from 8-week mindfulness interventions. The benefits from this study include improvement in or resolution of insomnia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Mindfulness) | Experimental | Other: Mindfulness MeditationThis arm will receive mindfulness-based interventions through a mobile application |
| Control (Sleep Advice) | No intervention | –This is the control arm that will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 18
- Meet the diagnostic criteria for an insomnia disorder. Defined as difficulty initiating or maintaining sleep despite adequate opportunity, with at least one symptom of an associated daytime impairment. Additional quantitative insomnia criteria following research recommendations include frequency (defined as sleep onset latency (SOL) or wake after sleep onset (WASO) > 30 minutes at least 3 nights per week and for chronicity, defined as symptoms lasting > 6 months.
- Have access to an iOS or Android smartphone or a desktop computer with Internet access
- Participants will be required to sign an informed consent form
Key exclusion criteria (7 listed)
- Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
- Uncontrolled psychiatric conditions requiring immediate treatment outside of the study, including current major depressive episode
- Comorbid sleep disorders including obstructive sleep apnea
- Current use of hypnotic or sedating medications for the purpose of insomnia
- Inadequate proficiency in English to complete the protocol
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 MeditationMindfulness Meditation delivered through a mobile application | Other | Experimental (Mindfulness) |
Primary outcome
Change in Insomnia Severity (Insomnia Severity Index)
Time frame: 8 weeks, 3 and 6 month follow-up
Insomnia Severity Index (ISI): The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. This will be administered at baseline, after 8-weeks and at a 3 and 6-month follow-up. The index will be sent to by post and. It will take approximately 5 minutes to complete.
Change in Actigraphy determined wake time (TWT)
Time frame: 2-week screening, 8-week intervention, 3 and 6-month follow-up
Actigraphy: Sleep onset latency (SOL) and wake after sleep onset (WASO) will be determined using wrist actigraphy. Participants will be provided with an actiwatch during the screening interview conducted at the beginning of the study. The actiwatch will be worn on the non-dominant arm 24 hours a day, except for while bathing, during the 2-week screening period. Additionally, the actiwatch will be worn for one week after the 8-week intervention and for one week prior to the 3 and 6-month follow-up. Participants will send the actiwatch to the investigator by post after each measurement period. The actiwatch will be sent to participants by post before the next measurement point; apart from the first time point where the participant will be given the actiwatch.
2 secondary outcomes
Review of mobile-based mindfulness meditation application for insomnia
Time frame: 6 months
Mindfulness (CAMS-R)
Time frame: Baseline, 8-weeks, 3 and 6-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Nicholas Hart, MD study chair
Guys and St Thomas NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Insomnia, run by Guy's and St Thomas' NHS Foundation Trust.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity (Insomnia Severity Index) (time frame: 8 weeks, 3 and 6 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2020.