NCT03663244

Evaluating Effectiveness of Stress Reduction Programmes in the Community

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress-related Problem

Interventions

Type	Name	Description
BEHAVIORAL	MBSR	Standardised stress reduction programme with established efficacy
BEHAVIORAL	LSR	Existing stress reduction programme in a Danish municipality

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-04-04
• Completion: 2018-08-02
• First posted: 2018-09-10
• Last updated: 2020-12-17

Locations

1 site across 1 country: Denmark