Stress-related ProblemNCT03663244
Evaluating Effectiveness of Stress Reduction Programmes in the Community
A study testing MBSR and LSR in people with Stress-related Problem, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress-related Problem
- What is being tested?
- MBSR and LSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2018to 2 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- able to understand, speak, and read Danish.
Who cannot join
- acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- abuse of alcohol, drugs, medicine
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Aarhus, 8000
About this study
Official title: 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.
- Conditions
- Stress-related Problem
- Being tested
- MBSR, LSR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Standardised stress reduction programme with established efficacy
LSRBehavioural
Existing stress reduction programme in a Danish municipality
| Study group | Role | What they receive |
|---|---|---|
| MindfulnessBasedStressReduction(MBSR) | Experimental | 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. Receives: Behavioral: MBSR |
| Local Stress Reduction (LSR) | Experimental | 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. Receives: Behavioral: LSR |
| Wait-list | No intervention | Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment-rate
Accept among total target group
Measured: over 4 months
Intervention-competition-rates participation
Accept of the MBSR and the LSR programme defined by participation in >4 meetings
Measured: 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
Measured: over 8 weeks
Proportions_ lost-to-follow-up
Risk of selection bias. Proportions of allocated participants lost to follow-up
Measured: over 8-10 weeks
Secondary outcomes (33)
Proportions_Completed_PSS
Proportions without missings in: Perceived Stress Scale
Measured: twice over 8-10 weeks
Proportions_Completed_SCL_5
Proportions without missings in: Symptom check list_5
Measured: twice over 8-10 weeks
Proportions_Completed_WHO_5
Proportions without missings in: WHO_5
Measured: twice over 8-10 weeks
Proportions_Completed_BRS
Proportions without missings in: Brief Resiliens Scale
Measured: twice over 8-10 weeks
Proportions_Completed_ARSQ
Proportions without missings in: Amsterdam Resting State Questionnaire
Measured: twice over 8-10 weeks
Proportions_Completed_FFMQ
Proportions without missings in: Five Facet Mindfulness Questionnaire
Measured: twice over 8-10 weeks
Proportions_Completed_SCS
Proportions without missings in: Neffs Self-Compassion-Scale
Measured: twice over 8-10 weeks
Proportions_Completed_EQ
Proportions without missings in: Decentring scale
Measured: twice over 8-10 weeks
Proportions_measured_sysbp
Proportions without missings in: systolic blood pressure
Measured: twice over 8-10 weeks
Proportions_measured_diabp
Proportions without missings in: diastolic blood pressure
Measured: twice over 8-10 weeks
Proportions_measured_weight
Proportions without missings in: weight
Measured: twice over 8-10 weeks
Proportions_measured_waist
Proportions without missings in: waist
Measured: twice over 8-10 weeks
Proportions_completed_tova
Proportions without missings in: TOVA-test
Measured: twice over 8-10 weeks
Proportions_measured_cholesterol
Proportions without missings in: S-cholesterol
Measured: twice over 8-10 weeks
Proportions_measured_crp
Proportions without missings in: C-Reaktivt Protein
Measured: twice over 8-10 weeks
Proportions_measured_il6
Proportions without missings in: inflammationmarker IL-6
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: over 8-10 weeks
Proposed_Effects_tova
Differences between groups at 8-week follow
Measured: 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
Measured: 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
Measured: 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
Measured: over 8-10 weeks
dehydroepiandrosterone-sulfate (DHEAS)
Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow
Measured: over 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start12 Mar 2018
- Primary completion4 Apr 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress-related ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Juul, PhD, Principal investigator, Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663244
- Sponsor's protocol ID
- 2018-03-3065
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32228533
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is High Quality Effectiveness Research on Effective Stress Reduction in the Community Possible? -a Three-armed Parallel Pilot Trial in a Danish Municipality
- ClinicalTrials.gov ID
- NCT03663244
- Acronym / sponsor ID
- 2018-03-3065
- Conditions
- Stress-related Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MindfulnessBasedStressReduction(MBSR) | Experimental | Behavioral: MBSRStandardised, 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. |
| Local Stress Reduction (LSR) | Experimental | Behavioral: LSRLocal 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. |
| Wait-list | No intervention | –Usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- able to understand, speak, and read Danish.
Key exclusion criteria (3 listed)
- acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
- abuse of alcohol, drugs, medicine
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRStandardised stress reduction programme with established efficacy | Behavioural | MindfulnessBasedStressReduction(MBSR) |
| LSRExisting stress reduction programme in a Danish municipality | Behavioural | Local Stress Reduction (LSR) |
Primary outcome
Recruitment-rate
Time frame: over 4 months
Accept among total target group
Intervention-competition-rates participation
Time frame: over 8 weeks
Accept of the MBSR and the LSR programme defined by participation in >4 meetings
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
Proportions_ lost-to-follow-up
Time frame: over 8-10 weeks
Risk of selection bias. Proportions of allocated participants lost to follow-up
33 secondary outcomes
Proportions_Completed_PSS
Time frame: twice over 8-10 weeks
Proportions_Completed_SCL_5
Time frame: twice over 8-10 weeks
Proportions_Completed_WHO_5
Time frame: twice over 8-10 weeks
Proportions_Completed_BRS
Time frame: twice over 8-10 weeks
Proportions_Completed_ARSQ
Time frame: twice over 8-10 weeks
Proportions_Completed_FFMQ
Time frame: twice over 8-10 weeks
Proportions_Completed_SCS
Time frame: twice over 8-10 weeks
Proportions_Completed_EQ
Time frame: twice over 8-10 weeks
Proportions_measured_sysbp
Time frame: twice over 8-10 weeks
Proportions_measured_diabp
Time frame: twice over 8-10 weeks
Proportions_measured_weight
Time frame: twice over 8-10 weeks
Proportions_measured_waist
Time frame: twice over 8-10 weeks
Proportions_completed_tova
Time frame: twice over 8-10 weeks
Proportions_measured_cholesterol
Time frame: twice over 8-10 weeks
Proportions_measured_crp
Time frame: twice over 8-10 weeks
Proportions_measured_il6
Time frame: twice over 8-10 weeks
Proposed_Effects_PSS
Time frame: over 8-10 weeks
Proposed_Effects_SCL_5
Time frame: over 8-10 weeks
Proposed_Effects_WHO_5
Time frame: over 8-10 weeks
Proposed_Effects_BRS
Time frame: over 8-10 weeks
Proposed_Effects__ARSQ
Time frame: over 8-10 weeks
Proposed_Effects_FFMQ
Time frame: over 8-10 weeks
Proposed_Effects_SCS
Time frame: over 8-10 weeks
Proposed_Effects_EQ
Time frame: over 8-10 weeks
Proposed_Effects_sysbp
Time frame: over 8-10 weeks
Proposed_Effects_diabp
Time frame: over 8-10 weeks
Proposed_Effects_weight
Time frame: over 8-10 weeks
Proposed_Effects_waist
Time frame: over 8-10 weeks
Proposed_Effects_tova
Time frame: over 8-10 weeks
Proposed_Effects_cholesterol
Time frame: over 8-10 weeks
Proposed_Effects_crp
Time frame: over 8-10 weeks
Proposed_Effects_il6
Time frame: over 8-10 weeks
dehydroepiandrosterone-sulfate (DHEAS)
Time frame: over 8-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 32228533Juul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Juul, PhD principal investigator
Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR and LSR in people with Stress-related Problem, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment-rate (time frame: over 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.