Evaluating Effectiveness of Stress Reduction Programmes in the Community

Not Applicable

Completed

• Conditions: Stress-related Problem
• Interventions: Behavioral: LSR; Behavioral: MBSR

• Registration Number: NCT03663244
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-12
• Primary Completion: 2018-04-04
• Status Verified: 2018-08
• Study Completion: 2018-08-02
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-10
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Stress Reduction (LSR)	LSR	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.
MindfulnessBasedStressReduction(MBSR)	MBSR	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proposed_Effects_tova	over 8-10 weeks	Differences between groups at 8-week follow
Proportions_Completed_PSS	twice over 8-10 weeks	Proportions without missings in: Perceived Stress Scale
Proportions_Completed_WHO_5	twice over 8-10 weeks	Proportions without missings in: WHO_5
Proportions_Completed_FFMQ	twice over 8-10 weeks	Proportions without missings in: Five Facet Mindfulness Questionnaire
Proportions_Completed_EQ	twice over 8-10 weeks	Proportions without missings in: Decentring scale
Proportions_measured_weight	twice over 8-10 weeks	Proportions without missings in: weight
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_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
dehydroepiandrosterone-sulfate (DHEAS)	over 8-10 weeks	Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow
Proportions_Completed_BRS	twice over 8-10 weeks	Proportions without missings in: Brief Resiliens Scale
Proportions_measured_sysbp	twice over 8-10 weeks	Proportions without missings in: systolic blood pressure
Proportions_Completed_SCS	twice over 8-10 weeks	Proportions without missings in: Neffs Self-Compassion-Scale
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
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__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_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_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
Proportions_Completed_ARSQ	twice over 8-10 weeks	Proportions without missings in: Amsterdam Resting State Questionnaire
Proportions_measured_il6	twice over 8-10 weeks	Proportions without missings in: inflammationmarker IL-6
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_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_SCL_5	twice over 8-10 weeks	Proportions without missings in: Symptom check list_5
Proportions_measured_diabp	twice over 8-10 weeks	Proportions without missings in: diastolic blood pressure
Proportions_measured_crp	twice over 8-10 weeks	Proportions without missings in: C-Reaktivt Protein
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_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_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_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_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_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

Trial Locations

Locations (1)

Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness; 🇩🇰 Aarhus, Denmark