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Evaluating Effectiveness of Stress Reduction Programmes in the Community

NCT03663244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-12-17

No results posted yet for this study

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

BEHAVIORAL

MBSR

Standardised stress reduction programme with established efficacy

BEHAVIORAL

LSR

Existing stress reduction programme in a Danish municipality

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lise Juul, PhD · Danish Center for Mindfulness, Department of Clinical Practice, Aarhus University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-04-04
Completion
2018-08-02

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663244 on ClinicalTrials.gov