A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting
Abstract Background The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in...
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| Format: | Article |
| Language: | English |
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BMC
2020-03-01
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| Series: | BMC Public Health |
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| Online Access: | http://link.springer.com/article/10.1186/s12889-020-08470-6 |
| _version_ | 1819151147351408640 |
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| author | Lise Juul Karen Johanne Pallesen Mette Bjerggaard Corina Nielsen Lone Overby Fjorback |
| author_facet | Lise Juul Karen Johanne Pallesen Mette Bjerggaard Corina Nielsen Lone Overby Fjorback |
| author_sort | Lise Juul |
| collection | DOAJ |
| description | Abstract Background The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in a Danish municipal health care center setting. Methods A three-armed parallel pilot RCT was conducted among 71 adults who contacted a Danish municipal health care center due to stress-related problems. Recruitment was made between January and April 2018 and followed usual procedures. Exclusion criteria: 1) acute treatment-demanding clinical depression or diagnosis of psychosis or schizophrenia, 2) abuse of alcohol, drugs, medicine, 3) pregnancy. Randomisation was performed by an independent data manager using the REDCap electronic data capture tool. The primary outcome was a description of RCT feasibility (recruitment and retention rates regarding intervention participation and 12-week follow-up). Secondary outcomes were completion rates regarding questionnaire data and proposed effect-estimates of outcome measures considered to be used in the following real RCT. Type of intervention and outcome assessment were not blinded. Results We recruited 71 of 129 eligible individuals from the target population (55, 95%CI: 46–64). Forty-two (59%) were females. Median age: 44 years (1-quartile:34, 3-quartile:50). Twenty-nine (41%) had < 16 years of education. Forty-eight (68%) were employed; 30 of these 48 (63%) were on sick leave. Mean scores for perceived stress (PSS): 25.4 ± 5.3; symptoms of anxiety and depression (SCL-5): 2.9 ± 0.6, and well-being (WHO-5): 31.7 ± 8.5 indicated a need for intervention. 16/24 (67, 95%CI: 45 to 84) who were allocated to MBSR and 17/23 (74, 95%CI: 52 to 90) who were allocated to LSR participated in ≥5 sessions. The loss to follow-up at 12 weeks: MBSR: 5 (21% (95% CI: 7 to 42), LSR: 5 (22% (95% CI: 7 to 44) and waiting list: 4 (17% (95% CI: 5 to 37). This was acceptable and evenly distributed. The results indicated MBSR to be superior. Conclusions An RCT assessing the effectiveness of stress reduction interventions in a real-life municipal health care setting is feasible among adults with a clear need for stress reduction interventions based on scores on mental health. Trial registration ClinicalTrials.gov. Identifier: NCT03663244 . Registered September 10, 2018. |
| first_indexed | 2024-12-22T14:28:46Z |
| format | Article |
| id | doaj.art-64d21c29826f4a7c976927e9dd25933e |
| institution | Directory Open Access Journal |
| issn | 1471-2458 |
| language | English |
| last_indexed | 2024-12-22T14:28:46Z |
| publishDate | 2020-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Public Health |
| spelling | doaj.art-64d21c29826f4a7c976927e9dd25933e2022-12-21T18:22:48ZengBMCBMC Public Health1471-24582020-03-0120111610.1186/s12889-020-08470-6A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care settingLise Juul0Karen Johanne Pallesen1Mette Bjerggaard2Corina Nielsen3Lone Overby Fjorback4Department of Clinical Medicine, Danish Center for Mindfulness, Aarhus UniversityDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus UniversityDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus UniversityDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus UniversityDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus UniversityAbstract Background The purpose of the present study was to conduct a pilot randomised controlled trial (RCT) to lend support to a larger effectiveness RCT comparing Mindfulness-Based Stress Reduction (MBSR), a locally-developed stress reduction intervention (LSR) and a waiting list control group in a Danish municipal health care center setting. Methods A three-armed parallel pilot RCT was conducted among 71 adults who contacted a Danish municipal health care center due to stress-related problems. Recruitment was made between January and April 2018 and followed usual procedures. Exclusion criteria: 1) acute treatment-demanding clinical depression or diagnosis of psychosis or schizophrenia, 2) abuse of alcohol, drugs, medicine, 3) pregnancy. Randomisation was performed by an independent data manager using the REDCap electronic data capture tool. The primary outcome was a description of RCT feasibility (recruitment and retention rates regarding intervention participation and 12-week follow-up). Secondary outcomes were completion rates regarding questionnaire data and proposed effect-estimates of outcome measures considered to be used in the following real RCT. Type of intervention and outcome assessment were not blinded. Results We recruited 71 of 129 eligible individuals from the target population (55, 95%CI: 46–64). Forty-two (59%) were females. Median age: 44 years (1-quartile:34, 3-quartile:50). Twenty-nine (41%) had < 16 years of education. Forty-eight (68%) were employed; 30 of these 48 (63%) were on sick leave. Mean scores for perceived stress (PSS): 25.4 ± 5.3; symptoms of anxiety and depression (SCL-5): 2.9 ± 0.6, and well-being (WHO-5): 31.7 ± 8.5 indicated a need for intervention. 16/24 (67, 95%CI: 45 to 84) who were allocated to MBSR and 17/23 (74, 95%CI: 52 to 90) who were allocated to LSR participated in ≥5 sessions. The loss to follow-up at 12 weeks: MBSR: 5 (21% (95% CI: 7 to 42), LSR: 5 (22% (95% CI: 7 to 44) and waiting list: 4 (17% (95% CI: 5 to 37). This was acceptable and evenly distributed. The results indicated MBSR to be superior. Conclusions An RCT assessing the effectiveness of stress reduction interventions in a real-life municipal health care setting is feasible among adults with a clear need for stress reduction interventions based on scores on mental health. Trial registration ClinicalTrials.gov. Identifier: NCT03663244 . Registered September 10, 2018.http://link.springer.com/article/10.1186/s12889-020-08470-6Feasibility studies (MeSH)Pilot Projects (MeSH)Pragmatic Clinical Trial (MeSH)Community Mental Health Services (MeSH)Stress, Psychological (MeSH)Mindfulness-based Stress Reduction |
| spellingShingle | Lise Juul Karen Johanne Pallesen Mette Bjerggaard Corina Nielsen Lone Overby Fjorback A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting BMC Public Health Feasibility studies (MeSH) Pilot Projects (MeSH) Pragmatic Clinical Trial (MeSH) Community Mental Health Services (MeSH) Stress, Psychological (MeSH) Mindfulness-based Stress Reduction |
| title | A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting |
| title_full | A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting |
| title_fullStr | A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting |
| title_full_unstemmed | A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting |
| title_short | A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting |
| title_sort | pilot randomised trial comparing a mindfulness based stress reduction course a locally developed stress reduction intervention and a waiting list control group in a real life municipal health care setting |
| topic | Feasibility studies (MeSH) Pilot Projects (MeSH) Pragmatic Clinical Trial (MeSH) Community Mental Health Services (MeSH) Stress, Psychological (MeSH) Mindfulness-based Stress Reduction |
| url | http://link.springer.com/article/10.1186/s12889-020-08470-6 |
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