Evaluating Effectiveness of Stress Reduction Programmes in the Community

• ClinicalTrials.gov Identifier: NCT03663244
• Recruitment Status: Completed
• First Posted: September 10, 2018
• Last Update Posted: December 17, 2020
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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
33. dehydroepiandrosterone-sulfate (DHEAS) [ Time Frame: over 8-10 weeks ]
    Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Denmark

Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness

Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT03663244
• Other Study ID Numbers: 2018-03-3065
• First Posted: September 10, 2018
• Last Update Posted: December 17, 2020
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No