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InsomniaNCT05812443

Assessment of Sleep Quality and Mental Health After Using Meditation

A study testing Shabad Kriya Meditation and Relaxing reading in people with Insomnia and Insomnia Chronic, run by Federal University of Minas Gerais at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Insomnia, Insomnia Chronic, Insomnia Disorder
What is being tested?
Shabad Kriya Meditation and Relaxing reading
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteBrazil
Study dates
10 Apr 2023to Mar 2024
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of insomnia (Insomnia Severity Index between 8-28)

Who cannot join

  • Major medical or psychiatric problems
  • Who has used sleeping pills or sleep-disrupting medications in the last 30 days prior to participating in the study
  • Who will need to use sleeping pills or sleep-disrupting medications during the study

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Federal University of Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

Other trials in Brazil

About this study

Official title: Assessment of Sleep Quality and Mental Health After Using Meditation: a Randomized Controlled Trial

This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems.

Read the detailed description

Participants selected for this clinical trial will be randomized into two groups: group 1 (intervention), with 87 participants undergoing 30 minutes of Shabad Kriya meditation before going to sleep, and group 2 (control), with 87 participants who will perform 30 minutes of relaxing reading before going to sleep. In addition, participants will complete the demographic data form; a sleep quality diary; and the scales: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PBS), Five Facets of Mindfulness (FFMQ), Daily Spiritual Experiences (DSES), Functional Assessment of Chronic Illness Therapy - Wellness Scale Spiritual (FACIT- 12), Duke Religiosity Index (DUREL), Quality of Life - Brief Mode (WHOQOL-Bref) and the Depression, Anxiety and Stress Scale (DASS 21). The study is open to the general community, and those interested are screened through the "Insomnia Severity Index" and questionnaires about health conditions. For conducting and guiding the intervention and completing the research instruments, online meetings will be held with the participants. The sleep quality diary will be completed for fourteen days before the start of the intervention (Baseline). Data collection will be carried out with online Google Forms questionnaires, sent through links in digital media, such as messages or emails, or made available in printed form. The main outcome measure will be sleep efficiency calculated using data from the sleep diary. Data from participants with ISI greater than or equal to 10 will be compared before and after the intervention. Additionally, data analysis of participants with ISI above or greater than 8 will be performed. At the end of the eighth week of the intervention (Shabad Kriya meditation or Relaxing reading), as well as one month after the end of the intervention, and three months after the end of the intervention, the participants will again fill in the questionnaires described above, for statistical comparisons.

Being tested
Shabad Kriya Meditation, Relaxing reading
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Anxiety Disorders, Stress Disorders, Traumatic, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shabad Kriya MeditationOther

    Also called Meditation

    The Shabad Krya meditation technique, used in Kundalini Yoga, will be performed by the participants of this intervention group for 8 consecutive weeks, for 30 minutes, before going to sleep. This group will be trained by a Kundalini Yoga teacher with extensive experience in Shabad Krya meditation. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

  • Relaxing readingOther

    Relaxing reading will be performed by the participants of this control group for 8 consecutive weeks, for 30 minutes, before going to sleep. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

Study groups in NCT05812443
Study groupRoleWhat they receive
Shabad Kriya MeditationExperimental87 participants (intervention group) will be trained to perform Shabad Kriya meditation for 30 minutes, daily, before going to sleep, for 8 weeks
Receives: Other: Shabad Kriya Meditation
Relaxing readingActive comparator87 participants (control group) will perform relaxing reading for 30 minutes, daily, before going to sleep, for 8 weeks
Receives: Other: Relaxing reading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Sleep Efficiency Change

    Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep. Sleep efficiency will be calculated from online sleep diaries that will be completed by participants in this study at baseline (T1), immediately after after 8 weeks of intervention (T2), 1 month (T3) and 3 months (T4) after intervention. Sleep efficiency is calculated using sleep parameters extracted from these diaries as sleep onset latency (SOL), total sleep time (TST), total wake time (TWT), Wake After Sleep Onset (WASO).

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

Secondary outcomes (9)
  1. Self-Reported Quality of Life Change

    Self-reported quality of life will be measured at baseline (T1), immediately after after 8 weeks of intervention (T2), 1 month (T3) and 3 months (T4) after intervention using the Quality of Life - Brief Mode of World Health Organization (WHOQOL-Bref), a short 26-question version validated questionnaire. The WHOQOL-Bref provides a quality of life measure with four domain scores. Each item is weighted on a 0-5 interval scale. The WHOQOL-BREF score is then calculated according to the method described by the WHO, by totaling the 4 domain scores (physical health; psychological health; social relationships; and environment). The calculation method of the scores in a certain domain is: (summation of the scores in each domain) x 4 / (number of items in a category). The adjusted scores of each domain are as low as 4 points and as high as 20 points. The overall score ranges from 16 to 80, where higher scores denote a higher life quality.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  2. Depression Anxiety Stress Scale (DASS)-21 Change

    Change in Depression, Anxiety, and Stress will be measured using the Depression, Anxiety and Stress Scales short form (DASS-21). Each of the 21 items has a minimum value of 0 and a maximum value of 3, and summed to yield independent depression, anxiety, and stress scores. Higher scores indicate severe psychological distress.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  3. Duke University Religion Index (DUREL) Change

    The Duke University Religion Index (DUREL) is a five-item measure of religious involvement. The instrument assesses the three major dimensions of religiosity that were identified during a consensus meeting sponsored by the National Institute on Aging (organizational religious activity, non-organizational religious activity, and intrinsic religiosity). The DUREL measures each of these dimensions by a separate "subscale". The DUREL has been used in many published studies conducted throughout the world and is available in many validated different languages questionnaires.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  4. Insomnia Severity Index (ISI) Change

    Insomnia Severity Index (ISI) will be used to assess insomnia-related complaints. It is a short and easy self-applied scale with 7 items scored from 0 to 4, with a total score varying from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia involvement. Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. Data from participants with ISI greater than or equal to 10 will be compared before and after the intervention. Additionally, data analysis of participants with ISI above or greater than 8 will be performed.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  5. Pittsburgh Sleep Quality Index (PSQI) Change

    The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality and disturbances over a 1-month period. Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The PSQI has seven components, with a global PSQI score > 5 is indicative of poor sleep quality.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  6. The Perceived Stress Scale (PSS) Change

    The Perceived Stress Scale (PSS) is a five-point Likert-type scale and consists of 14 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. PSS-14 scores range from 0 to 56, with 0-35 point range indicating normal stress level, 35-56 point range indicating that the individual is under stress.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  7. Functional Assessment of Chronic Illness Therapy (FACIT-Sp-12) Change

    The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) will be used to assess spiritual well-being and comprises 12 items, each rated on a 5-point scale by the respondent. The first eight items constitute the meaning/peace factor, and the last four items constituted the faith factor. The FACIT-SP-12 questionnaire assesses a sense of meaning, peace, and comfort and strength derived from faith. The FACIT-SP-12 has a 5-point Likert-type scale format. Total scores range from 0 to 48 with higher scores indicating higher levels of spiritual well-being.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  8. Daily spiritual experiences scale (DSES) Change

    The Daily spiritual experiences scale (DSES) will be used to assess ordinary experiences of connection with the transcendent in daily life. It includes constructs such as awe, gratitude, mercy, sense of connection with the transcendent and compassionate love. It also includes measures of awareness of discernment/inspiration and a sense of deep inner peace. The DSES is a 16-item self-report measure questionnaire, and higher scores are associated with higher life satisfaction and self-reported good health. The first 15 items are arranged on a Likert-type scale, with scores ranging from 1 (many times a day) to 6 (never or almost never). The item 16 is answered on a 4-point scale (from 1 = not at all to 4 = as close as possible). The score of item 16 is inverted to maintain the same direction as the other items. The total score is obtained by adding the scores of the 16 items, ranging from 16 to 94. Lower scores reflect a higher frequency of spiritual experiences

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

  9. Five Facet Mindfulness Questionnaire (FFMQ-BR) Change

    The Five Facet Mindfulness Questionnaire (FFMQ-BR) will be used to assess the characteristics of mindfulness. The FFMQ-BR is subdivided into five main evaluation factors (observation, description, non-judgment, non-reactivity and conscientious acting) evaluated in the situations addressed in each item, and each item is rated by the participant using a scale ranging from 1 to 5 points, where 1 represents "never or almost never" and 5 represents "always or almost always". The total score of the questionnaire will be calculated and this score will be compared before and after all intervention to assess whether the participants' level of attention has increased.

    Measured: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start10 Apr 2023
  3. Primary completionSep 2023 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05812443
Sponsor's protocol ID
CAAE: 60582522.5.0000.5149
Status last verified
May 2023
First submitted
17 Mar 2023
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.

    PubMed 33928908
  • Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

    PubMed 21532953
  • Lin CY, Saffari M, Koenig HG, Pakpour AH. Effects of religiosity and religious coping on medication adherence and quality of life among people with epilepsy. Epilepsy Behav. 2018 Jan;78:45-51. doi: 10.1016/j.yebeh.2017.10.008. Epub 2017 Nov 22.

    PubMed 29175219

Questions about this trial

What is this clinical trial studying?

A study testing Shabad Kriya Meditation and Relaxing reading in people with Insomnia and Insomnia Chronic, run by Federal University of Minas Gerais at 1 site in Brazil.

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 1 inclusion and 3 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 10 May 2023. 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 Brazil. 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?

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?

Mean Sleep Efficiency Change (time frame: Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4)). 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 NCT05812443, which also lists 3 linked publications.

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 10 May 2023.

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