Evaluating Effectiveness of Stress Reduction Programmes in the Community

University of Aarhus

Status: Completed

Conditions: Stress-related Problem

Treatments: Behavioral: MBSR; Behavioral: LSR

Study type: Interventional

Funder types: Other

Identifiers

NCT03663244

2018-03-3065

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 3 patient groups

MindfulnessBasedStressReduction(MBSR)

Experimental group

Description:

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.

Treatment:

Behavioral: MBSR

Local Stress Reduction (LSR)

Experimental group

Description:

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.

Treatment:

Behavioral: LSR

Wait-list

No Intervention group

Description:

Usual practice