Evaluating Effectiveness of Stress Reduction Programmes in the Community

NCT03663244 | Completed

• 1 other identifier: 2018-03-3065
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Recruitment-rate

  Accept among total target group

  over 4 months

• Intervention-competition-rates participation

  Accept of the MBSR and the LSR programme defined by participation in \>4 meetings

  over 8 weeks

• 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

• Proportions_ lost-to-follow-up

  Risk of selection bias. Proportions of allocated participants lost to follow-up

  over 8-10 weeks

Secondary Outcomes (33)

• Proportions_Completed_PSS

  twice over 8-10 weeks

• Proportions_Completed_SCL_5

  twice over 8-10 weeks

• Proportions_Completed_WHO_5

  twice over 8-10 weeks

• Proportions_Completed_BRS

  twice over 8-10 weeks

• Proportions_Completed_ARSQ

  twice over 8-10 weeks

Study Arms (3)

MindfulnessBasedStressReduction(MBSR)

EXPERIMENTAL

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.

Behavioral: MBSR

Local Stress Reduction (LSR)

EXPERIMENTAL

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.

Behavioral: LSR

Wait-list

NO INTERVENTION

Usual practice

Interventions

MBSR BEHAVIORAL

Standardised stress reduction programme with established efficacy

MindfulnessBasedStressReduction(MBSR)

LSR BEHAVIORAL

Existing stress reduction programme in a Danish municipality

Local Stress Reduction (LSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old
• able to understand, speak, and read Danish.

You may not qualify if:

• acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
• abuse of alcohol, drugs, medicine
• pregnancy.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32228533 DERIVED

Study Officials

• Lise Juul, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 10, 2018
• Study Start: March 12, 2018
• Primary Completion: April 4, 2018
• Study Completion: August 2, 2018
• Last Updated: December 17, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)