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Dissertation Project Title: Effects of a Mindfulness-Based Intervention in Chronic Heart Failure

NCT04871178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-04

No results posted yet for this study

Summary

Patients with Chronic Heart Failure diagnosed and conventional treated, but still symptomatic (i.e. breathlessness, fatigue) is invited.

Eligible patients are randomised to (1) care as usual (i.e. optimized medical treatment) or (2) care as usual (i.e. optimized medical treatment) in combination with an 8-week mindfulness-based educational and training program.

Specific research questions:

* How are self-reported symptoms of breathlessness, fatigue, difficult sleeping, anxiety and depression affected by a mindfulness-based educational and training program (MBI)?
* Does the implementation of an 8-week Mindfulness-based program have any impact on personal experiences of well-being and health?
* What effects does an 8-week MBI have on objective signs of importance for the progression of heart failure?

Conditions

Interventions

BEHAVIORAL

Mindfulness-based intervention

Eight, 2-hour instructor-led MBI group sessions once a week for 8 weeks, combined with formal meditative training at home for 20 minutes per day, 6 days a week. Course material consists of facts booklet, weekly training manuals, audio recordings on a CD, with the five formal guided meditative exercises (body scan, breathing anchor, breathing space, mindful movements, sitting meditation). The weekly home-work also included informal training of being present in daily life activities. The program is provided according to the standard MBI protocol. Compared to MBSR and MBCT durations of formal meditative practices are shorter and no 'all-day in silence' session is included. Because of participants' physical limitations and safety, the 'mindful movements' sequence, is adapted and performed in a sitting position. Adherence to the MBI was followed by self-reported weekly training in manuals asked to be submitted at group sessions.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Lena M Björck Associate Professor, PhD, RN · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-10
Primary Completion
2013-12-31
Completion
2013-12-31

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Entities

Diseases

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 NCT04871178 on ClinicalTrials.gov