Evaluating Effectiveness of Stress Reduction Programmes in the Community

December 16, 2020 updated by: University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment-rate
Time Frame: over 4 months
Accept among total target group
over 4 months
Intervention-competition-rates participation
Time Frame: over 8 weeks
Accept of the MBSR and the LSR programme defined by participation in >4 meetings
over 8 weeks
Proportions_other_treatment
Time Frame: over 8 weeks
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
Time Frame: over 8-10 weeks
Risk of selection bias. Proportions of allocated participants lost to follow-up
over 8-10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportions_Completed_PSS
Time Frame: twice over 8-10 weeks
Proportions without missings in: Perceived Stress Scale
twice over 8-10 weeks
Proportions_Completed_SCL_5
Time Frame: twice over 8-10 weeks
Proportions without missings in: Symptom check list_5
twice over 8-10 weeks
Proportions_Completed_WHO_5
Time Frame: twice over 8-10 weeks
Proportions without missings in: WHO_5
twice over 8-10 weeks
Proportions_Completed_BRS
Time Frame: twice over 8-10 weeks
Proportions without missings in: Brief Resiliens Scale
twice over 8-10 weeks
Proportions_Completed_ARSQ
Time Frame: twice over 8-10 weeks
Proportions without missings in: Amsterdam Resting State Questionnaire
twice over 8-10 weeks
Proportions_Completed_FFMQ
Time Frame: twice over 8-10 weeks
Proportions without missings in: Five Facet Mindfulness Questionnaire
twice over 8-10 weeks
Proportions_Completed_SCS
Time Frame: twice over 8-10 weeks
Proportions without missings in: Neffs Self-Compassion-Scale
twice over 8-10 weeks
Proportions_Completed_EQ
Time Frame: twice over 8-10 weeks
Proportions without missings in: Decentring scale
twice over 8-10 weeks
Proportions_measured_sysbp
Time Frame: twice over 8-10 weeks
Proportions without missings in: systolic blood pressure
twice over 8-10 weeks
Proportions_measured_diabp
Time Frame: twice over 8-10 weeks
Proportions without missings in: diastolic blood pressure
twice over 8-10 weeks
Proportions_measured_weight
Time Frame: twice over 8-10 weeks
Proportions without missings in: weight
twice over 8-10 weeks
Proportions_measured_waist
Time Frame: twice over 8-10 weeks
Proportions without missings in: waist
twice over 8-10 weeks
Proportions_completed_tova
Time Frame: twice over 8-10 weeks
Proportions without missings in: TOVA-test
twice over 8-10 weeks
Proportions_measured_cholesterol
Time Frame: twice over 8-10 weeks
Proportions without missings in: S-cholesterol
twice over 8-10 weeks
Proportions_measured_crp
Time Frame: twice over 8-10 weeks
Proportions without missings in: C-Reaktivt Protein
twice over 8-10 weeks
Proportions_measured_il6
Time Frame: twice over 8-10 weeks
Proportions without missings in: inflammationmarker IL-6
twice over 8-10 weeks
Proposed_Effects_PSS
Time Frame: 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
over 8-10 weeks
Proposed_Effects_SCL_5
Time Frame: 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
over 8-10 weeks
Proposed_Effects_WHO_5
Time Frame: 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
over 8-10 weeks
Proposed_Effects_BRS
Time Frame: 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
over 8-10 weeks
Proposed_Effects__ARSQ
Time Frame: 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
over 8-10 weeks
Proposed_Effects_FFMQ
Time Frame: 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
over 8-10 weeks
Proposed_Effects_SCS
Time Frame: 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
over 8-10 weeks
Proposed_Effects_EQ
Time Frame: 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
over 8-10 weeks
Proposed_Effects_sysbp
Time Frame: 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
over 8-10 weeks
Proposed_Effects_diabp
Time Frame: 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
over 8-10 weeks
Proposed_Effects_weight
Time Frame: 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
over 8-10 weeks
Proposed_Effects_waist
Time Frame: 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
over 8-10 weeks
Proposed_Effects_tova
Time Frame: over 8-10 weeks
Differences between groups at 8-week follow
over 8-10 weeks
Proposed_Effects_cholesterol
Time Frame: 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
over 8-10 weeks
Proposed_Effects_crp
Time Frame: 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
over 8-10 weeks
Proposed_Effects_il6
Time Frame: 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
over 8-10 weeks
dehydroepiandrosterone-sulfate (DHEAS)
Time Frame: over 8-10 weeks
Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow
over 8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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