CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Mindfulness-based interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04871178
NCT04871178N/ACompleted

Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients With Chronic Heart Failure

Göteborg University·interventional·Posted May 4, 2021·Updated May 4, 2021

In Brief

A clinical study evaluating Mindfulness-based intervention for Chronic Heart Failure. Completed, enrolled 50 participants.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2021
Enrollment StartOct 10, 2010
Primary CompletionDec 31, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.2 years ago

Interventions

Mindfulness-based interventionbehavioral

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.