Evaluating Effectiveness of Stress Reduction Programmes in the Community

Stress-related Problem Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663244
• Other study ID #: 2018-03-3065
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Stress-related Problem

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