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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
71
Standardised stress reduction programme with established efficacy
Existing stress reduction programme in a Danish municipality
Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Aarhus, Denmark
Recruitment-rate
Accept among total target group
Time frame: over 4 months
Intervention-competition-rates participation
Accept of the MBSR and the LSR programme defined by participation in \>4 meetings
Time frame: over 8 weeks
Proportions_other_treatment
Risk of dilution of intervention effects. Proportions of allocated participants that have participated in other stress reduction treatment during the trial
Time frame: over 8 weeks
Proportions_ lost-to-follow-up
Risk of selection bias. Proportions of allocated participants lost to follow-up
Time frame: over 8-10 weeks
Proportions_Completed_PSS
Proportions without missings in: Perceived Stress Scale
Time frame: twice over 8-10 weeks
Proportions_Completed_SCL_5
Proportions without missings in: Symptom check list\_5
Time frame: twice over 8-10 weeks
Proportions_Completed_WHO_5
Proportions without missings in: WHO\_5
Time frame: twice over 8-10 weeks
Proportions_Completed_BRS
Proportions without missings in: Brief Resiliens Scale
Time frame: twice over 8-10 weeks
Proportions_Completed_ARSQ
Proportions without missings in: Amsterdam Resting State Questionnaire
Time frame: twice over 8-10 weeks
Proportions_Completed_FFMQ
Proportions without missings in: Five Facet Mindfulness Questionnaire
Time frame: twice over 8-10 weeks
Proportions_Completed_SCS
Proportions without missings in: Neffs Self-Compassion-Scale
Time frame: twice over 8-10 weeks
Proportions_Completed_EQ
Proportions without missings in: Decentring scale
Time frame: twice over 8-10 weeks
Proportions_measured_sysbp
Proportions without missings in: systolic blood pressure
Time frame: twice over 8-10 weeks
Proportions_measured_diabp
Proportions without missings in: diastolic blood pressure
Time frame: twice over 8-10 weeks
Proportions_measured_weight
Proportions without missings in: weight
Time frame: twice over 8-10 weeks
Proportions_measured_waist
Proportions without missings in: waist
Time frame: twice over 8-10 weeks
Proportions_completed_tova
Proportions without missings in: TOVA-test
Time frame: twice over 8-10 weeks
Proportions_measured_cholesterol
Proportions without missings in: S-cholesterol
Time frame: twice over 8-10 weeks
Proportions_measured_crp
Proportions without missings in: C-Reaktivt Protein
Time frame: twice over 8-10 weeks
Proportions_measured_il6
Proportions without missings in: inflammationmarker IL-6
Time frame: twice over 8-10 weeks
Proposed_Effects_PSS
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_SCL_5
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_WHO_5
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_BRS
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects__ARSQ
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_FFMQ
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_SCS
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_EQ
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_sysbp
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_diabp
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_weight
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_waist
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_tova
Differences between groups at 8-week follow
Time frame: over 8-10 weeks
Proposed_Effects_cholesterol
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_crp
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
Proposed_Effects_il6
Differences with 95% Confidence intervals between groups at 8-week follow adjusted for baseline-value and adjusted for baseline-value, age, sex, educational level and history of mental disorder
Time frame: over 8-10 weeks
dehydroepiandrosterone-sulfate (DHEAS)
Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow
Time frame: over 8-10 weeks
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