Stress-related Problem
Conditions
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.
Interventions
BEHAVIORALMBSR
Standardised stress reduction programme with established efficacy
BEHAVIORALLSR
Existing stress reduction programme in a Danish municipality
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment-rate | over 4 months | Accept among total target group |
| Intervention-competition-rates participation | over 8 weeks | Accept of the MBSR and the LSR programme defined by participation in \>4 meetings |
| Proportions_other_treatment | over 8 weeks | Risk of dilution of intervention effects. Proportions of allocated participants that have participated in other stress reduction treatment during the trial |
| Proportions_ lost-to-follow-up | over 8-10 weeks | Risk of selection bias. Proportions of allocated participants lost to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportions_Completed_SCL_5 | twice over 8-10 weeks | Proportions without missings in: Symptom check list\_5 |
| Proportions_Completed_WHO_5 | twice over 8-10 weeks | Proportions without missings in: WHO\_5 |
| Proportions_Completed_BRS | twice over 8-10 weeks | Proportions without missings in: Brief Resiliens Scale |
| Proportions_Completed_ARSQ | twice over 8-10 weeks | Proportions without missings in: Amsterdam Resting State Questionnaire |
| Proportions_Completed_FFMQ | twice over 8-10 weeks | Proportions without missings in: Five Facet Mindfulness Questionnaire |
| Proportions_Completed_SCS | twice over 8-10 weeks | Proportions without missings in: Neffs Self-Compassion-Scale |
| Proportions_Completed_EQ | twice over 8-10 weeks | Proportions without missings in: Decentring scale |
| Proportions_measured_sysbp | twice over 8-10 weeks | Proportions without missings in: systolic blood pressure |
| Proportions_measured_diabp | twice over 8-10 weeks | Proportions without missings in: diastolic blood pressure |
| Proportions_measured_weight | twice over 8-10 weeks | Proportions without missings in: weight |
| Proportions_measured_waist | twice over 8-10 weeks | Proportions without missings in: waist |
| Proportions_completed_tova | twice over 8-10 weeks | Proportions without missings in: TOVA-test |
| Proportions_measured_cholesterol | twice over 8-10 weeks | Proportions without missings in: S-cholesterol |
| Proportions_measured_crp | twice over 8-10 weeks | Proportions without missings in: C-Reaktivt Protein |
| Proposed_Effects__ARSQ | over 8-10 weeks | 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 |
| Proposed_Effects_PSS | over 8-10 weeks | 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 |
| Proposed_Effects_SCL_5 | over 8-10 weeks | 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 |
| Proposed_Effects_FFMQ | over 8-10 weeks | 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 |
| Proposed_Effects_SCS | over 8-10 weeks | 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 |
| Proposed_Effects_EQ | over 8-10 weeks | 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 |
| Proposed_Effects_sysbp | over 8-10 weeks | 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 |
| Proposed_Effects_diabp | over 8-10 weeks | 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 |
| Proposed_Effects_weight | over 8-10 weeks | 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 |
| Proposed_Effects_waist | over 8-10 weeks | 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 |
| Proposed_Effects_tova | over 8-10 weeks | Differences between groups at 8-week follow |
| Proposed_Effects_cholesterol | over 8-10 weeks | 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 |
| Proposed_Effects_crp | over 8-10 weeks | 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 |
| Proposed_Effects_il6 | over 8-10 weeks | 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 |
| dehydroepiandrosterone-sulfate (DHEAS) | over 8-10 weeks | Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow |
| Proportions_measured_il6 | twice over 8-10 weeks | Proportions without missings in: inflammationmarker IL-6 |
| Proposed_Effects_WHO_5 | over 8-10 weeks | 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 |
| Proposed_Effects_BRS | over 8-10 weeks | 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 |
| Proportions_Completed_PSS | twice over 8-10 weeks | Proportions without missings in: Perceived Stress Scale |
Countries
Denmark
Outcome results
None listed