Evaluating Effectiveness of Stress Reduction Programmes in the Community

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress-related Problem

Intervention / Treatment
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* Behavioral: MBSR
* Behavioral: LSR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MindfulnessBasedStressReduction(MBSR)<br>Standardised, curriculum-based MBSR-programme: 2.5-hour weekly group sessions over 8 weeks; one 6-hour silence retreat day; and 45 minutes daily homework 6 days a week. | Behavioral: MBSR<br>* Standardised stress reduction programme with established efficacy<br>|
| Experimental: Local Stress Reduction (LSR)<br>Local stress reduction programme ; developed and delivered by two local psychologists. This programme is delivered in groups of 12 participants, in 2.5-hour weekly sessions over 8 weeks and includes approximately 10 minutes daily homework between the sessions. | Behavioral: LSR<br>* Existing stress reduction programme in a Danish municipality<br>|
| No Intervention: Wait-list<br>Usual practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment-rate | Accept among total target group | over 4 months | 
| Intervention-competition-rates participation | Accept of the MBSR and the LSR programme defined by participation in >4 meetings | 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 | over 8 weeks | 
| Proportions_ lost-to-follow-up | Risk of selection bias. Proportions of allocated participants lost to follow-up | over 8-10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions_Completed_PSS | Proportions without missings in: Perceived Stress Scale | twice over 8-10 weeks | 
| Proportions_Completed_SCL_5 | Proportions without missings in: Symptom check list_5 | twice over 8-10 weeks | 
| Proportions_Completed_WHO_5 | Proportions without missings in: WHO_5 | twice over 8-10 weeks | 
| Proportions_Completed_BRS | Proportions without missings in: Brief Resiliens Scale | twice over 8-10 weeks | 
| Proportions_Completed_ARSQ | Proportions without missings in: Amsterdam Resting State Questionnaire | twice over 8-10 weeks | 
| Proportions_Completed_FFMQ | Proportions without missings in: Five Facet Mindfulness Questionnaire | twice over 8-10 weeks | 
| Proportions_Completed_SCS | Proportions without missings in: Neffs Self-Compassion-Scale | twice over 8-10 weeks | 
| Proportions_Completed_EQ | Proportions without missings in: Decentring scale | twice over 8-10 weeks | 
| Proportions_measured_sysbp | Proportions without missings in: systolic blood pressure | twice over 8-10 weeks | 
| Proportions_measured_diabp | Proportions without missings in: diastolic blood pressure | twice over 8-10 weeks | 
| Proportions_measured_weight | Proportions without missings in: weight | twice over 8-10 weeks | 
| Proportions_measured_waist | Proportions without missings in: waist | twice over 8-10 weeks | 
| Proportions_completed_tova | Proportions without missings in: TOVA-test | twice over 8-10 weeks | 
| Proportions_measured_cholesterol | Proportions without missings in: S-cholesterol | twice over 8-10 weeks | 
| Proportions_measured_crp | Proportions without missings in: C-Reaktivt Protein | twice over 8-10 weeks | 
| Proportions_measured_il6 | Proportions without missings in: inflammationmarker IL-6 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | over 8-10 weeks | 
| Proposed_Effects_tova | Differences between groups at 8-week follow | 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 | 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 | 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 | over 8-10 weeks | 
| dehydroepiandrosterone-sulfate (DHEAS) | Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow | over 8-10 weeks |