Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes

NCT04417153 | Unknown

• 1 other identifier: S-19-176
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness training has been gaining popularity in the past decade as a means of improving general well-being. This trend appears in response to the new stressors that have arisen with the increased stress of the 21st century. Studies have shown that the psychological state of metacognitive awareness encapsulated in mindfulness can promote the decreasing of stress as well as the secondary effect of improving sleep quality; both outcome measures of this study. While the body of research evaluating these benefits is growing, there is limited emphasis placed on the individual differences that can affect the overall efficacy of mindfulness training. Our aim in this study is to observe the effects of mindfulness training on perceived stress levels as well as on sleep using subjective measures in a large sample of trainees. To achieve this, participants will be recruited from a pool of people who have signed up for a 4-week foundational mindfulness or 8-week mindfulness based stress reduction course at Brahm Centre. Questionnaires will be administered both before and after these courses to evaluate both stress levels and sleep habits as well as other factors which could contribute to the efficacy of mindfulness training. These inventories will probe the different facets of interpersonal differences that could serve to influence the effectiveness of the mindfulness intervention. In addition, the investigators will also test the effect of conducting the course online during a situation of emergency, like it is the partial lockdown that was implemented in Singapore due to the spread of Covid-19. The proposed study has the potential to provide new insights into the factors that affect the efficacy of mindfulness on stress and sleep, in a situation of non-emergency (until February the 6th 2020) as well as during a period of heightened restrictions (DORSCON Orange, from 7th of February to 6th of April 2020) and a partial lockdown (from 7th of April to 1st of June 2020, or until resume of normal activity). Further, the investigators hope to build an algorithm that can predict the potential effectiveness of mindfulness on a person by person basis. This could serve as a foundation for future recommendations for mindfulness training as well as open the door for future studies that could serve to further customize the mindfulness training framework to accommodate individual differences

Conditions

Stress, Psychological; Sleep Initiation and Maintenance Disorders

Keywords

Mindfulness; Covid; lockdown; Stress; Sleep

Outcome Measures

Primary Outcomes (2)

• Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score

  Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score above 5 suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality

  Up to one month

• Change in subjective measures of Stress: Perceived Stress Scale (PSS)

  The PSS measures whether different aspects of life were perceived as stressful by participants on a 5-point scale (where 0 was never and 4 was very often) in the past month. Positively worded questions are reversed scored and all 10 questions ratings are summarised into a total score, which ranges from 0 to 40, with higher scores indicating more perceived stress.

  Up to one month

Secondary Outcomes (4)

• Change in Subjective Time in Bed (TIB)

  Up to one month

• Change in Subjective Total Sleep Time (TST)

  Up to one month

• Change in Subjective Sleep Onset Latency (SOL)

  Up to one month

• Change in Subjective Wake After Sleep Onset (WASO)

  Up to one month

Study Arms (3)

Mindfulness based intervention, Non Emergency (MBI-NE)

* 4 week Mindfulness foundation course face to face (MF-NE) or * 8 week Mindfulness Based stress reduction face to face (MBSR-NE) The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions. Participants will be provided handouts for the information covered during these talks and discussions. Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together

Behavioral: Mindfulness Based Intervention

Mindfulness based intervention, DORSCON Orange (MBI-Orange))

* 4 week Mindfulness foundation course face to face (MF-Orange) or * 8 week Mindfulness Based stress reduction face to face (MBSR-Orange) The content of these courses are the same as in the non emergency ones, and consist of four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques. Participants will also be provided with the same handouts for the information covered during these talks and discussions. Classes are done at the Mindfulness centres providing the courses, with face to face sessions with the teacher and up to 30 participants together.

Behavioral: Mindfulness Based Intervention

Mindfulness based intervention, Partial lockdown (MBI-Covid)

* 4 week Mindfulness foundation course online (MF-Covid) or * 8 week Mindfulness Based stress reduction online, partial lockdown situation (MBSR-Covid) The content of these courses are the same as in the non emergency ones. Participants will also be provided with the same handouts for the information covered during these talks and discussions. During the partial lockdown, classes can only be held online, using platform as zoom with the teacher and up to around 17 participants together.

Behavioral: Mindfulness Based Intervention

Interventions

Mindfulness Based Intervention BEHAVIORAL

The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion). Participants will be provided handouts for the information covered during these talks and discussions.These can be done either face to face or online.

Also known as: MBI

Mindfulness based intervention, DORSCON Orange (MBI-Orange)); Mindfulness based intervention, Non Emergency (MBI-NE); Mindfulness based intervention, Partial lockdown (MBI-Covid)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any individual above 21 years old enrolled in Mindfulness-Based Stress Reduction/Mindfulness Foundation course at Brahm Centre or with a mindfulness course with Potential Project Singapore that is also interested in participating in the study.

You may qualify if:

• Any individual above 21 years old enrolled in Mindfulness-Based Stress Reduction/Mindfulness Foundation course at Brahm Centre or with a mindfulness course with Potential Project can be included in the study.

Sponsors & Collaborators

• National University of Singapore: lead
• Potential project, www.potentialproject.com: collaborator
• Brahm Centre, Singapore: collaborator

Study Sites (1)

National University Singapore

Singapore, 119077, Singapore

RECRUITING

Related Publications (9)

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  PMID: 2748771 BACKGROUND

• Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.

  PMID: 14749092 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.

  PMID: 21534932 BACKGROUND

• Heidenreich T, Tuin I, Pflug B, Michal M, Michalak J. Mindfulness-based cognitive therapy for persistent insomnia: a pilot study. Psychother Psychosom. 2006;75(3):188-9. doi: 10.1159/000091778. No abstract available.

  PMID: 16636636 BACKGROUND

• Kabat-Zinn, J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.

  BACKGROUND

• Birnie, K., Speca, M., & Carlson, L. (2010). Exploring self-compassion and empathy in the context of mindfulness-based stress reduction (MBSR). Stress And Health, 26(5), 359-371. doi: 10.1002/smi.1305

  BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Suyi Y, Meredith P, Khan A. Effectiveness of Mindfulness Intervention in Reducing Stress and Burnout for Mental Health Professionals in Singapore. Explore (NY). 2017 Sep-Oct;13(5):319-326. doi: 10.1016/j.explore.2017.06.001. Epub 2017 Jul 1.

  PMID: 28780213 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Julian Lim, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Lim, PhD

CONTACT

+6565165438; julian.lim@nus.edu.sg

Francesca Perini, PhD

CONTACT

+6565165438; francesca@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: September 20, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

SG (1)