Evaluating Effectiveness of Stress Reduction Programmes in the Community

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

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 Overview

• Status: Completed
• Conditions: Stress-related Problem
• Intervention / Treatment: Behavioral: MBSR; Behavioral: LSR

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MindfulnessBasedStressReduction(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.	Behavioral: MBSR; Standardised stress reduction programme with established efficacy
Experimental: Local Stress Reduction (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.	Behavioral: LSR; Existing stress reduction programme in a Danish municipality
No Intervention: Wait-list; Usual practice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018-03-3065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No