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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Care as usual: (i.e. best medical treatment) | |
| Experimental: Mindfulness-Based Intervention<br>Care as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based educational and training program. | Behavioral: Mindfulness-based intervention<br>* 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.<br>* Other names: MBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Change from baseline to follow-up at week 10, will be measured at the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-administered questionnaire with two sub-scales to detect possible presence of anxiety (HADS-A) and/or depression (HADS-D). Both sub-scales include 7 items, with four-point scales ranging from 0 to 3, with total sum-score ranging from 0-21, and defined as 0-7 (normal), 8-10 (possible case), and 11-21 (probable case) of anxiety disorders or depression, and the patient in need of additional psychiatric treatment. Optimal cut-off for both subscales is set to ≥8. The HADS was provided at visits, answered at home, and sent to University address. | 10 weeks | 
| Depression | Change from baseline to follow-up at week 10, will be measured at the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-administered questionnaire with two sub-scales to detect possible presence of anxiety (HADS-A) and/or depression (HADS-D). Both sub-scales include 7 items, with four-point scales ranging from 0 to 3, with total sum-score ranging from 0-21, and defined as 0-7 (normal), 8-10 (possible case), and 11-21 (probable case) of anxiety disorders or depression, and the patient in need of additional psychiatric treatment. Optimal cut-off for both subscales is set to ≥8. The HADS was provided at visits, answered at home, and sent to University address. | 10 weeks | 
| Psychological and General Well-Being | Change from baseline to follow-up at week 10, will be measured at the Psychological and General Well-Being (PGWB) index. The PGWB is a 22-item self-administered questionnaire designed to measure self-representations of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The six response options were coded 1-6 in accordance with Swedish studies, and the total PGWB sum score was ranging from 22 to 132, with defined categories (1) score 22-82 (Severe distress); (2) score 83-94 (Moderate distress); score 95-132 (Positive well-being). The PGWB was provided at visits, answered at home, and sent in to University address. | 10 weeks | 
| Sense of coherence | Change from baseline to follow-up at week 10, will be measured at the self-administered questionnaire Sense of coherence (SOC-13) total index. The SOC-13 consisting of 13 items, all with seven-point scale and two anchoring responses. With higher scores indicating higher personal capabilities to perceive the world and stressful events in life as comprehensible, manageable, and meaningful defined as high SOC. The psychometric tested Swedish version of SOC-13, and the total score categories defined as: 30-60 (Low SOC); 61-75 (Moderate SOC); 76-91 (High SOC) is used. The SOC-13 was provided at visits, answered at home, and sent in to University address. | 10 weeks | 
| Health | Change from baseline to follow-up at week 10, on self-reported health, will be measured at the Swedish version of the 36-item Short Form Health Survey (SF-36) General Health (GH) Index. The SF-36 GH index consists of five items, with questions focusing participants' perception of their health, with five response choices each, and higher points indicating better health. The SF-36 questionnaire were included in the first phase (pilot 1), then temporary removed. The value of health status as measured in the SF-36, was reconsidered 2012 and the instrument was reinstated in 2013 (pilot 2). The SF-36 was provided at visits, answered at home, and sent in to University address. | 10 weeks | 
| Self-reported symptoms of impaired sleep | Change from baseline to follow-up at week 10, will be measured at the Karolinska Sleep Questionnaire - sleep quality index (KSQ-sqi). Which is a sub-scale including four questions, with high scores indicating good sleep quality. The KSQ was provided at visits, answered at home, and sent to University address. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Well-being, Feasibility study, Mindfulness interventions, Anxiety, Depression, Psychological Distress, Health, Sense of coherence, Sleep, Dyspnea, Shortness of Breath, Breathlessness, Patient-reported outcomes