Evidence map›Paper›PMID 32228533›Full record

Trial reportBMC public health2020

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.

Lise Juul, Karen Johanne Pallesen, Mette Bjerggaard, Corina Nielsen, Lone Overby Fjorback

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03663244 (Is High Quality Effectiveness Research on Effective Stress Reduction in the Community Possible? -a Three-armed Parallel Pilot Trial in a Danish Municipality), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03663244 nacompletednot on this map

Is High Quality Effectiveness Research on Effective Stress Reduction in the Community Possible? -a Three-armed Parallel Pilot Trial in a Danish Municipality

TypeinterventionalSponsorUniversity of AarhusRan2018 to 2018Enrolled71ConditionsStress-related ProblemArmsMBSR, LSR
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Lise JuulDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark. lise.juul@clin.au.dk.
Karen Johanne PallesenDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark.
Mette BjerggaardDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark.
Corina NielsenDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark.
Lone Overby FjorbackDepartment of Clinical Medicine, Danish Center for Mindfulness, Aarhus University, Gudrunsvej 78, 3, 8220, Brabrand, Denmark.
Aarhus University · DK

Funding

TrygFonden 119327
6 · The paper itself

Abstract

backgroundThe 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.

methodsA 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.

resultsWe 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.

conclusionsAn 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 registrationClinicalTrials.gov. Identifier: NCT03663244. Registered September 10, 2018.

Indexed as

AdultAnxietyCommunity Mental Health ServicesDenmarkDepressionFeasibility StudiesFemaleHumansMaleMiddle AgedMindfulnessOutcome Assessment, Health CarePilot ProjectsStress, PsychologicalSurveys and QuestionnairesWaiting ListsAbbreviationsACT Acceptance and commitment therapyARSQ The Amsterdam Resting State QuestionnaireBRS Brief resilience scaleCI Confidence intervalCommunity Mental Health Services (MeSH)EffectivenessEQ Experiences questionnaire - decentering sub scaleFeasibility studies (MeSH)FFMQ The five facet mindfulness questionnaireLSR Locally developed stress reduction interventionMBSRMBSR Mindfulness-based stress reductionMindfulnessMindfulness-based Stress ReductionPilot Projects (MeSH)Pragmatic Clinical Trial (MeSH)PSS Perceived stress scaleRCT Randomised controlled trialSCL-5 Hopkins Symptom Check List-5SCS Self-compassion scaleStress, Psychological (MeSH)WHO-5 WHO-5-wellbeing scaleWHO World Health Organization

Identifiers

PMID32228533
PMCPMC7106861
OpenAlexW3013502347

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.