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Completed

NCT Number: NCT03663244

Evaluating Effectiveness of Stress Reduction Programmes in the Community

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.

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Key information

Conditions

Stress-related Problem

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBSR

Behavioral

Standardised stress reduction programme with established efficacy

LSR

Behavioral

Existing stress reduction programme in a Danish municipality

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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