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Evaluating Effectiveness of Stress Reduction Programmes in the Community

NCT ID: NCT03663244

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Stress-related Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MindfulnessBasedStressReduction(MBSR)

Standardised, curriculum-based MBSR-programme: 2.5-hour weekly group sessions over 8 weeks; one 6-hour silence retreat day; and 45 minutes daily homework 6 days a week.

Group Type EXPERIMENTAL

MBSR

Intervention Type BEHAVIORAL

Standardised stress reduction programme with established efficacy

Local Stress Reduction (LSR)

Local stress reduction programme ; developed and delivered by two local psychologists. This programme is delivered in groups of 12 participants, in 2.5-hour weekly sessions over 8 weeks and includes approximately 10 minutes daily homework between the sessions.

Group Type EXPERIMENTAL

LSR

Intervention Type BEHAVIORAL

Existing stress reduction programme in a Danish municipality

Wait-list

Usual practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MBSR

Standardised stress reduction programme with established efficacy

Intervention Type BEHAVIORAL

LSR

Existing stress reduction programme in a Danish municipality

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise Juul, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Juul L, Pallesen KJ, Bjerggaard M, Nielsen C, Fjorback LO. A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting. BMC Public Health. 2020 Mar 30;20(1):409. doi: 10.1186/s12889-020-08470-6.

Reference Type DERIVED
PMID: 32228533 (View on PubMed)

Other Identifiers

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2018-03-3065

Identifier Type: -

Identifier Source: org_study_id