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

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ClinicalTrials.gov Identifier: NCT04417153
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Potential project, www.potentialproject.com
Brahm Centre, Singapore
Information provided by (Responsible Party):
Julian Lim, National University, Singapore

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


Condition or disease Intervention/treatment
Stress, Psychological Sleep Initiation and Maintenance Disorders Behavioral: Mindfulness Based Intervention

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Group/Cohort Intervention/treatment
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
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.
Other Name: MBI

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
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.
Other Name: MBI

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
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.
Other Name: MBI




Primary Outcome Measures :
  1. Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index total Score [ Time Frame: Up to one month ]
    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

  2. Change in subjective measures of Stress: Perceived Stress Scale (PSS) [ Time Frame: Up to one month ]
    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.


Secondary Outcome Measures :
  1. Change in Subjective Time in Bed (TIB) [ Time Frame: Up to one month ]
    Measured within the Pittsburgh Sleep Quality Index questionnaire. This is the total perceived time in bed in minutes, calculated as item 3 of the PSQI ("When have you usually gotten up in the morning?") minus item 1 ("When have you usually gone to bed?")

  2. Change in Subjective Total Sleep Time (TST) [ Time Frame: Up to one month ]
    Measured within the Pittsburgh Sleep Quality Index questionnaire. Total sleep time reflects the amount of time in minutes participants were effectively sleeping while in bed, without periods of wakefulness, on average over the past month. This will be measured by item 4 of the PSQI questionnaires: "How many hours of actual sleep do you get at night?".

  3. Change in Subjective Sleep Onset Latency (SOL) [ Time Frame: Up to one month ]
    Measured within the Pittsburgh Sleep Quality Index. This is the perceived time, in minutes, that takes participants to fall asleep from the moment they go to bed. This corresponds to item 2 of the PSQI: "How long (in minutes) has it taken you to fall asleep each night?"

  4. Change in Subjective Wake After Sleep Onset (WASO) [ Time Frame: Up to one month ]
    Measured within the Pittsburgh Sleep Quality Index questionnaire. In addition to Sleep Onset Latency (Secondary outcome 1), a second subjective measure of sleep quality is extracted from the PSQI: time of perceived wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed (TST) minus total sleep time (TST) and minus sleep onset latency (SOL), in minutes. High WASO scores reflect low sleep continuity and poor sleep quality.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417153


Contacts
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Contact: Julian Lim, PhD +6565165438 julian.lim@nus.edu.sg
Contact: Francesca Perini, PhD +6565165438 francesca@nus.edu.sg

Locations
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Singapore
National University Singapore Recruiting
Singapore, Singapore, 119077
Contact: Julian Lim, PhD    +6565165438    julian.lim@nus.edu.sg   
Contact: Francesca Perini, PhD    +6565165438    francesca@nude.edu.sg   
Sponsors and Collaborators
National University, Singapore
Potential project, www.potentialproject.com
Brahm Centre, Singapore
Investigators
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Principal Investigator: Julian Lim, PhD National University, Singapore
Publications:
Kabat-Zinn, J. (1990) Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacourt.
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

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Responsible Party: Julian Lim, Assistant Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT04417153    
Other Study ID Numbers: S-19-176
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julian Lim, National University, Singapore:
Mindfulness
Covid
lockdown
Stress
Sleep
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Stress, Psychological
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders