Clinical trial NCT05812443: Assessment of Sleep Quality and Mental Health After Using Meditation
Official title: Assessment of Sleep Quality and Mental Health After Using Meditation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Insomnia Chronic
Insomnia Disorder
Sleep Disorder
Anxiety Disorders
Stress Disorder
Depressive Disorder
Quality of Life
Complementary Therapy
Spirituality
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2023-04-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Sleep Efficiency Change
timeFrame: 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:
measure: Self-Reported Quality of Life Change
timeFrame: 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)
measure: Depression Anxiety Stress Scale (DASS)-21 Change
timeFrame: 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)
measure: Duke University Religion Index (DUREL) Change
timeFrame: 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)
measure: Insomnia Severity Index (ISI) Change
timeFrame: 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)
measure: Pittsburgh Sleep Quality Index (PSQI) Change
timeFrame: 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)
measure: The Perceived Stress Scale (PSS) Change
timeFrame: 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)
measure: Functional Assessment of Chronic Illness Therapy (FACIT-Sp-12) Change
timeFrame: 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)
measure: Daily spiritual experiences scale (DSES) Change
timeFrame: 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)
measure: Five Facet Mindfulness Questionnaire (FFMQ-BR) Change
timeFrame: 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)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.