Clinical trial NCT04871178: Dissertation Project Title: Effects of a Mindfulness-Based Intervention in Chronic Heart Failure
Official title: Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2021-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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?

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

Rationale: Despite progress in medical treatment, many patients with heart failure, still suffers from limiting symptoms with negative impact on their prognosis, wellbeing and health. Psychological distress, including anxiety and depression, is prevalent and difficult to treat in heart failure. Mindfulness-based interventions (MBIs), have shown beneficial effects on psychological and physiological symptoms, health and quality of life in other chronic conditions. The aims of the project were therefore to explore the feasibility and effects of MBI on symptoms and signs, well-being and health in patients diagnosed with chronic heart failure.

Hypothesis: was that outpatients with chronic heart failure would benefit from participating in an 8-week Mindfulness-based educational and training program (MBI) in addition to usual care (comprising standard health care and optimized medical treatment). With respect to (1) alleviate impact of symptoms (fatigue, breathlessness, impaired sleep, anxiety and depression), and (2) improve perceived wellbeing and health, and the sense of coherence (patient-reported outcomes), and (3) objective signs of importance for heart failure progression (heart rate, breathing rate, functional classification and capacity).

Study design: A prospective study, with a two-armed randomized and controlled designed, including two visits, was planned and initiated, integrated within the framework of a part-financed dissertation project. Complemented with qualitative research on participants' experiences of health, symptoms and the MBI.

Intervention: The intervention group received an 8-week MBI program in addition to treatment and care as usual (UC+MBI), while the control group received only treatment and care as usual (UC).

Data is collected in interviews and with clinical measurement of signs on site, and with validated patient-reported questionnaires, before and after 8-week intervention (UC+MBI) / Control (UC) period. Interviews were recorded and coded. Participants receive a minor physical examination with measurements of blood pressure, heart rate, breathing rate, weight and height, and assessment with a six-minute walk test. Participants is also provided with questionnaires to be answered at home, and send in to the University.

Nature and extend of the burden and risks: Due to the character of the MBI, with focused attention on thoughts, feelings and bodily sensations, emotional reactions may be a risk (as is described in Informed Consent Form). Participants were free to contact with the MBI instructor or a counsellor, during study period. The burden of participation (i.e. time investment in learning the mindfulness-based meditative training and extra study examinations) may be compensated by the possible benefits.

The present study has been carried through within the framework of a part-financed dissertation project with four sub-projects. The feasibility study, showing patients recruitment and flow through the study, with results of the MBI on symptoms and signs in patients with chronic heart failure is published \[1\].

The study has not prior been registered at clinicalTrial.gov, due to the nature of the interventional pilot study, as was original initiated as a part of a Master Thesis, and registration was not required at the time recruitment began in 2010. Also, it is not until now we realize the value to retrospectively register the study, when able to provide the new knowledge gained by the project in the sub-project II, III and IV.

The study has been conducted in several phases, including a pre-pilot phase and two pilot phases. In the pre-pilot phase, the study protocol with the Research Person Information (Informed Consent Form) was evaluated with patients randomly assigned to a MBI (n=3) or control group (n=3). Results on participants' experiences of the MBI, and the effects on the outcomes, were analyzed with a qualitative approach and described in a Master's thesis (in Swedish).

The present study protocol was approved in 2010, by the Regional Ethical Board in Gothenburg, Sweden (No. 265:10), with a few minor revisions, including tuning down the benefits, and the advice to review if possible, to reduce the number of instruments in the study.

All through the study has been performed according to the principles of the Declaration of Helsinki. All participants provided written and Informed Consent and signed the ICF before beginning the study, and were informed of the right of free withdrawal.

The first pilot phase lasted from 2010 to 2011. In February 2012 the study was approved for a doctoral student position, with research grants from the Centre for Person-Centred Care at the University of Gothenburg (GPCC). GPCC was founded by the Swedish Government´s grant for Strategic Research Areas, Care Sciences (Application to Swedish Council no. 2009-1088). The second phase of the study was conducted in 2013, called the "Main study", but the RCT was to be transformed to a feasibility study.

The Analysis plan into the dissertation project: Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-being and Health in patients with Chronic Heart Failure, includes both qualitative and quantitative methods. Briefly, the original focus on qualitative research, shifted to emphasis quantitative methods. The original plan to use parametric methods, to compare the study groups, shifted to Non-parametric Mann-Whitney U test. Due to the small sample size, and the ordinal level of data. Statistical analysis was carried out in consultation with Healthmetrics, University of Gothenburg, Sweden. Two separate sets of outcome variables were constructed prior analysis. The first set was on symptoms and signs and included in published paper \[1\]. The other set is on the psychological outcomes (anxiety and depression), well-being, sense of coherence and health \[paper II). Paper III is a qualitative: Experiences of Breathing and Shortness of Breath with Chronic Heart Failure - A descriptive and explorative study. The 4th paper is a Mixed-Method study on the effects of MBI on problematic shortness of breath experiences with heart failure.

Topics of research in this project may be relevant for many patients with heart failure and professionals. The reasons for delay of publishing results in the present study is several, what matters now is the ability to share the new knowledge on the effects of MBI on psychological distress and health in heart failure with patients and professionals all over the world. That is the heart goal for this application to ClinicalTrial.gov.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-reported impact of fatigue
timeFrame: 10 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 10 weeks
measure: Depression
timeFrame: 10 weeks
measure: Psychological and General Well-Being
timeFrame: 10 weeks
measure: Sense of coherence
timeFrame: 10 weeks
measure: Health
timeFrame: 10 weeks
measure: Self-reported symptoms of impaired sleep
timeFrame: 10 weeks
Other outcomes:
measure: Heart rate
timeFrame: 10 weeks
measure: Respiratory rate
timeFrame: 10 weeks
measure: Functional classification
timeFrame: 10 weeks
measure: Breathlessness related to physical exertion
timeFrame: 10 weeks
measure: Tiredness related to physical exertion
timeFrame: 10 weeks
measure: Functional capacity
timeFrame: 10 weeks
measure: Shortness of breath
timeFrame: 10 weeks
measure: Other symptoms
timeFrame: 10 weeks
measure: Health self-rated on Visual Analogue Scale
timeFrame: 10 weeks
measure: Well-being self-rated on Likert-scale
timeFrame: 10 weeks
Locations:
Study officials:
affiliation: Göteborg University
name: Lena M Björck Associate Professor, PhD, RN
role: PRINCIPAL_INVESTIGATOR
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