Clinical trial NCT03663244: Evaluating Effectiveness of Stress Reduction Programmes in the Community
Official title: Is High Quality Effectiveness Research on Effective Stress Reduction in the Community Possible? -a Three-armed Parallel Pilot Trial in a Danish Municipality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress-related Problem
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim was to assess the feasibility and to improve the quality of a definitive Randomised Controlled Trial (RCT) with the purpose to investigate the effectiveness of stress reduction programmes in the community. (A definitive RCT = an RCT with statistical power). Intermediate aims: to investigate 1) the potential generalizability: the accept among the target population (people with perceived stress) of participating in an RCT, including a description of the participant characteristics and the recruitment time ; 2) the risk of intervention effect dilution: the accept of allocated intervention in terms of programme completion ; 3) the risk of contamination: potential participation in (other) stress reduction treatment beyond the allocated intervention or non-intervention ; 4) the risk of selection problems or -bias: the lost to follow-up in the trial arms ; and finally, 5) the risk of information problems: the accept among participants of chosen outcome measurements, sensitivity of chosen outcome measures to detect effects, and indications of potential effects.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* able to understand, speak, and read Danish.

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine
* pregnancy.

Primary outcomes:
measure: Recruitment-rate
timeFrame: over 4 months
measure: Intervention-competition-rates participation
timeFrame: over 8 weeks
measure: Proportions_other_treatment
timeFrame: over 8 weeks
measure: Proportions_ lost-to-follow-up
timeFrame: over 8-10 weeks
Secondary outcomes:
measure: Proportions_Completed_PSS
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_SCL_5
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_WHO_5
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_BRS
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_ARSQ
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_FFMQ
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_SCS
timeFrame: twice over 8-10 weeks
measure: Proportions_Completed_EQ
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_sysbp
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_diabp
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_weight
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_waist
timeFrame: twice over 8-10 weeks
measure: Proportions_completed_tova
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_cholesterol
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_crp
timeFrame: twice over 8-10 weeks
measure: Proportions_measured_il6
timeFrame: twice over 8-10 weeks
measure: Proposed_Effects_PSS
timeFrame: over 8-10 weeks
measure: Proposed_Effects_SCL_5
timeFrame: over 8-10 weeks
measure: Proposed_Effects_WHO_5
timeFrame: over 8-10 weeks
measure: Proposed_Effects_BRS
timeFrame: over 8-10 weeks
measure: Proposed_Effects__ARSQ
timeFrame: over 8-10 weeks
measure: Proposed_Effects_FFMQ
timeFrame: over 8-10 weeks
measure: Proposed_Effects_SCS
timeFrame: over 8-10 weeks
measure: Proposed_Effects_EQ
timeFrame: over 8-10 weeks
measure: Proposed_Effects_sysbp
timeFrame: over 8-10 weeks
measure: Proposed_Effects_diabp
timeFrame: over 8-10 weeks
measure: Proposed_Effects_weight
timeFrame: over 8-10 weeks
measure: Proposed_Effects_waist
timeFrame: over 8-10 weeks
measure: Proposed_Effects_tova
timeFrame: over 8-10 weeks
measure: Proposed_Effects_cholesterol
timeFrame: over 8-10 weeks
measure: Proposed_Effects_crp
timeFrame: over 8-10 weeks
measure: Proposed_Effects_il6
timeFrame: over 8-10 weeks
measure: dehydroepiandrosterone-sulfate (DHEAS)
timeFrame: over 8-10 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Study officials:
affiliation: Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University
name: Lise Juul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juul L, Pallesen KJ, Bjerggaard M, Nielsen C, Fjorback LO. 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. 2020 Mar 30;20(1):409. doi: 10.1186/s12889-020-08470-6.