Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Effectiveness of Stress Reduction Programmes in the Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663244
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress-related Problem Behavioral: MBSR Behavioral: LSR Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : August 2, 2018

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



Primary Outcome Measures :
  1. Recruitment-rate [ Time Frame: over 4 months ]
    Accept among total target group

  2. Intervention-competition-rates participation [ Time Frame: over 8 weeks ]
    Accept of the MBSR and the LSR programme defined by participation in >4 meetings

  3. 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

  4. Proportions_ lost-to-follow-up [ Time Frame: over 8-10 weeks ]
    Risk of selection bias. Proportions of allocated participants lost to follow-up


Secondary Outcome Measures :
  1. Proportions_Completed_PSS [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Perceived Stress Scale

  2. Proportions_Completed_SCL_5 [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Symptom check list_5

  3. Proportions_Completed_WHO_5 [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: WHO_5

  4. Proportions_Completed_BRS [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Brief Resiliens Scale

  5. Proportions_Completed_ARSQ [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Amsterdam Resting State Questionnaire

  6. Proportions_Completed_FFMQ [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Five Facet Mindfulness Questionnaire

  7. Proportions_Completed_SCS [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Neffs Self-Compassion-Scale

  8. Proportions_Completed_EQ [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: Decentring scale

  9. Proportions_measured_sysbp [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: systolic blood pressure

  10. Proportions_measured_diabp [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: diastolic blood pressure

  11. Proportions_measured_weight [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: weight

  12. Proportions_measured_waist [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: waist

  13. Proportions_completed_tova [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: TOVA-test

  14. Proportions_measured_cholesterol [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: S-cholesterol

  15. Proportions_measured_crp [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: C-Reaktivt Protein

  16. Proportions_measured_il6 [ Time Frame: twice over 8-10 weeks ]
    Proportions without missings in: inflammationmarker IL-6

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Proposed_Effects_tova [ Time Frame: over 8-10 weeks ]
    Differences between groups at 8-week follow

  30. 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

  31. 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

  32. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663244


Locations
Layout table for location information
Denmark
Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Lise Juul, PhD Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03663244    
Other Study ID Numbers: 2018-03-3065
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No