Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03663244
Other study ID # 2018-03-3065
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2018
Est. completion date August 2, 2018

Study information

Verified date August 2018
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date August 2, 2018
Est. primary completion date April 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MBSR
Standardised stress reduction programme with established efficacy
LSR
Existing stress reduction programme in a Danish municipality

Locations

Country Name City State
Denmark Aarhus University, Department of Clinical Medicine, Danish Center for Mindfulness Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment-rate Accept among total target group over 4 months
Primary Intervention-competition-rates participation Accept of the MBSR and the LSR programme defined by participation in >4 meetings over 8 weeks
Primary Proportions_other_treatment Risk of dilution of intervention effects. Proportions of allocated participants that have participated in other stress reduction treatment during the trial over 8 weeks
Primary Proportions_ lost-to-follow-up Risk of selection bias. Proportions of allocated participants lost to follow-up over 8-10 weeks
Secondary Proportions_Completed_PSS Proportions without missings in: Perceived Stress Scale twice over 8-10 weeks
Secondary Proportions_Completed_SCL_5 Proportions without missings in: Symptom check list_5 twice over 8-10 weeks
Secondary Proportions_Completed_WHO_5 Proportions without missings in: WHO_5 twice over 8-10 weeks
Secondary Proportions_Completed_BRS Proportions without missings in: Brief Resiliens Scale twice over 8-10 weeks
Secondary Proportions_Completed_ARSQ Proportions without missings in: Amsterdam Resting State Questionnaire twice over 8-10 weeks
Secondary Proportions_Completed_FFMQ Proportions without missings in: Five Facet Mindfulness Questionnaire twice over 8-10 weeks
Secondary Proportions_Completed_SCS Proportions without missings in: Neffs Self-Compassion-Scale twice over 8-10 weeks
Secondary Proportions_Completed_EQ Proportions without missings in: Decentring scale twice over 8-10 weeks
Secondary Proportions_measured_sysbp Proportions without missings in: systolic blood pressure twice over 8-10 weeks
Secondary Proportions_measured_diabp Proportions without missings in: diastolic blood pressure twice over 8-10 weeks
Secondary Proportions_measured_weight Proportions without missings in: weight twice over 8-10 weeks
Secondary Proportions_measured_waist Proportions without missings in: waist twice over 8-10 weeks
Secondary Proportions_completed_tova Proportions without missings in: TOVA-test twice over 8-10 weeks
Secondary Proportions_measured_cholesterol Proportions without missings in: S-cholesterol twice over 8-10 weeks
Secondary Proportions_measured_crp Proportions without missings in: C-Reaktivt Protein twice over 8-10 weeks
Secondary Proportions_measured_il6 Proportions without missings in: inflammationmarker IL-6 twice over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary Proposed_Effects_tova Differences between groups at 8-week follow over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary 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 over 8-10 weeks
Secondary dehydroepiandrosterone-sulfate (DHEAS) Plasma (µmol/L). Differences with 95% Confidence intervals between groups at 8-week follow over 8-10 weeks
See also
  Status Clinical Trial Phase
Completed NCT05059392 - TARA for Medical Students, a Single-arm Mixed Methods Pilot Study N/A
Active, not recruiting NCT05567913 - Change i Perceived Stress in School-age Students When Adding Physiotherapists to a School's Health Team.
Completed NCT04685252 - Investigating a Probiotic on Mothers' Mood and Stress N/A
Active, not recruiting NCT06391216 - The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers N/A
Completed NCT03593551 - Effects of Different Relaxation Interventions on Reducing Stress in Chinese Breastfeeding Mothers N/A
Completed NCT03725488 - The Impact of Background Music in Reducing Stress in Preclinical Dental Labs
Completed NCT01849718 - Nacadia Effect Study (NEST)
Recruiting NCT05833555 - Harlem Strong Mental Health Coalition N/A
Completed NCT05451758 - The Effectiveness of MBSR in Natural Environments N/A
Completed NCT03427515 - Probiotics and Examination-related Stress in Healthy Medical Students N/A
Completed NCT04266015 - Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery N/A
Completed NCT05930652 - Cumulative Stress and Mental Health in Young Adults