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

NCT04871178 | Completed

• 1 other identifier: Pro Ethical Sweden Dnr 265 10
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Chronic Heart Failure

Keywords

Feasibility study; Mindfulness interventions; Fatigue; Anxiety; Depression; Psychological Distress; Well-being; Health; Sense of coherence; Sleep; Dyspnea; Shortness of Breath; Breathlessness; Patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• Self-reported impact of fatigue

  Change from baseline to follow-up at week 10, will be measured at the Fatigue Severity Scale (FSS), a self-administered questionnaire including nine items investigating the impact of disabling fatigue on daily functioning during the past week. Grading of each item ranges from 1 to 7, with the total possible fatigue sum score ranging from 9 to 63, and higher scores indicating higher levels of indexed impact of fatigue. The FSS had not previously been tested in a heart failure population, and no cut-off score was found. The FSS was provided at visits and answered at home, and sent in to University address.

  10 weeks

Secondary Outcomes (6)

• Anxiety

  10 weeks

• Depression

  10 weeks

• Psychological and General Well-Being

  10 weeks

• Sense of coherence

  10 weeks

• Health

  10 weeks

Other Outcomes (10)

• Heart rate

  10 weeks

• Respiratory rate

  10 weeks

• Functional classification

  10 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Care as usual: (i.e. best medical treatment)

Mindfulness-Based Intervention

EXPERIMENTAL

Care as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based educational and training program.

Behavioral: Mindfulness-based intervention

Interventions

Mindfulness-based intervention BEHAVIORAL

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.

Also known as: MBI

Mindfulness-Based Intervention

Eligibility Criteria

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

You may qualify if:

• Diagnosed chronic heart (CHF) failure by echocardiography
• Functional class II-IV according to the New York Heart Association (NYHA)
• Symptoms of breathlessness and/or tiredness rated 2-5 by patients using five-point scales, ranging from asymptomatic (1) to symptoms at rest (5)
• Stable condition, that is no deterioration of heart failure symptoms or new CHF drug or hospitalizations because of decompensated heart failure within the last four weeks

You may not qualify if:

• Severe psychiatric diagnosis (requiring treatment)
• Severe substance abuse (documented in journal)
• Severe somatic disease with short expected survival (i.e., malignancy)
• Communication difficulties (i.e., impaired vision or hearing, need of an interpreter to understand Swedish)
• Cognitive or adherence difficulties (documented in journal)
• Unstable angina pectoris
• Post-partum cardiomyopathy
• Ongoing participation in any other interventional study
• Unwillingness to participate

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Related Publications (57)

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  BACKGROUND

• Norman J, Fu M, Ekman I, Bjorck L, Falk K. Effects of a mindfulness-based intervention on symptoms and signs in chronic heart failure: A feasibility study. Eur J Cardiovasc Nurs. 2018 Jan;17(1):54-65. doi: 10.1177/1474515117715843. Epub 2017 Jun 22.

  PMID: 28639841 RESULT

MeSH Terms

Conditions

Fatigue; Anxiety Disorders; Depression; Dyspnea

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Lena M Björck Associate Professor, PhD, RN

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A two-armed randomized, 8-week interventional and controlled (no intervention) feasibility study with two visits, one visit before (week 0) and one visit after intervention (week 10±1), with repeated measures

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: October 10, 2010
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share