NCT05812443

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

March 17, 2023

Last Update Submit

May 8, 2023

Conditions

InsomniaInsomnia ChronicInsomnia DisorderSleep DisorderAnxiety DisordersStress DisorderDepressive DisorderQuality of LifeComplementary TherapySpirituality

Outcome Measures

Primary Outcomes (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).

    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)

  • Self-Reported Quality of Life Change

    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)

  • Depression Anxiety Stress Scale (DASS)-21 Change

    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)

  • Duke University Religion Index (DUREL) Change

    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)

  • Insomnia Severity Index (ISI) Change

    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)

  • Pittsburgh Sleep Quality Index (PSQI) Change

    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 more secondary outcomes

Study Arms (2)

Shabad Kriya Meditation

EXPERIMENTAL

87 participants (intervention group) will be trained to perform Shabad Kriya meditation for 30 minutes, daily, before going to sleep, for 8 weeks

Other: Shabad Kriya Meditation

Relaxing reading

ACTIVE COMPARATOR

87 participants (control group) will perform relaxing reading for 30 minutes, daily, before going to sleep, for 8 weeks

Other: Relaxing reading

Interventions

Shabad Kriya MeditationOTHER

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.

Also known as: Meditation
Shabad Kriya Meditation
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.

Relaxing reading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 33928908BACKGROUND

  • 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.

    PMID: 21532953BACKGROUND

  • 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.

    PMID: 29175219BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake DisordersAnxiety DisordersStress Disorders, TraumaticDepressive Disorder

Interventions

Meditation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTrauma and Stressor Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 13, 2023

Study Start

April 10, 2023

Primary Completion

September 1, 2023

Study Completion

March 1, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)