Chronic Heart FailureNCT04871178
Dissertation Project Title: Effects of a Mindfulness-Based Intervention in Chronic Heart Failure
A study testing Mindfulness-based intervention in people with Chronic Heart Failure, run by Göteborg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2010to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Post-partum cardiomyopathy
- Ongoing participation in any other interventional study
- Unwillingness to participate
About this study
Official title: Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients With Chronic Heart Failure
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.
Read more
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?
Read the 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.
- Conditions
- Chronic Heart Failure
- Being tested
- Mindfulness-based intervention
- 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
- Medical subject headings
- Fatigue, Anxiety Disorders, Depression, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
Also called MBI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start10 Oct 2010
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Lena M Björck Associate Professor, PhD, RN, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871178
- Sponsor's protocol ID
- Pro Ethical Sweden Dnr 265 10
- Status last verified
- May 2021
- First submitted
- 28 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
PubMed 27207191Paren P, Schaufelberger M, Bjorck L, Lappas G, Fu M, Rosengren A. Trends in prevalence from 1990 to 2007 of patients hospitalized with heart failure in Sweden. Eur J Heart Fail. 2014 Jul;16(7):737-42. doi: 10.1002/ejhf.109. Epub 2014 May 26.
PubMed 24863749Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.
PubMed 15916924Barnes S, Gott M, Payne S, Parker C, Seamark D, Gariballa S, Small N. Prevalence of symptoms in a community-based sample of heart failure patients. J Pain Symptom Manage. 2006 Sep;32(3):208-16. doi: 10.1016/j.jpainsymman.2006.04.005.
PubMed 16939845Falk K, Swedberg K, Gaston-Johansson F, Ekman I. Fatigue is a prevalent and severe symptom associated with uncertainty and sense of coherence in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2007 Jun;6(2):99-104. doi: 10.1016/j.ejcnurse.2006.05.004. Epub 2006 Jul 10.
PubMed 16831569Janssen DJ, Spruit MA, Uszko-Lencer NH, Schols JM, Wouters EF. Symptoms, comorbidities, and health care in advanced chronic obstructive pulmonary disease or chronic heart failure. J Palliat Med. 2011 Jun;14(6):735-43. doi: 10.1089/jpm.2010.0479. Epub 2011 Apr 21.
PubMed 21510771Yohannes AM, Willgoss TG, Baldwin RC, Connolly MJ. Depression and anxiety in chronic heart failure and chronic obstructive pulmonary disease: prevalence, relevance, clinical implications and management principles. Int J Geriatr Psychiatry. 2010 Dec;25(12):1209-21. doi: 10.1002/gps.2463.
PubMed 20033905Wu JR, Lennie TA, Frazier SK, Moser DK. Health-Related Quality of Life, Functional Status, and Cardiac Event-Free Survival in Patients With Heart Failure. J Cardiovasc Nurs. 2016 May-Jun;31(3):236-44. doi: 10.1097/JCN.0000000000000248.
PubMed 25774841Steptoe A, Mohabir A, Mahon NG, McKenna WJ. Health related quality of life and psychological wellbeing in patients with dilated cardiomyopathy. Heart. 2000 Jun;83(6):645-50. doi: 10.1136/heart.83.6.645.
PubMed 10814621Falk K, Granger BB, Swedberg K, Ekman I. Breaking the vicious circle of fatigue in patients with chronic heart failure. Qual Health Res. 2007 Oct;17(8):1020-7. doi: 10.1177/1049732307306914.
PubMed 17928476Ekman I, Kjellstrom B, Falk K, Norman J, Swedberg K. Impact of device-guided slow breathing on symptoms of chronic heart failure: a randomized, controlled feasibility study. Eur J Heart Fail. 2011 Sep;13(9):1000-5. doi: 10.1093/eurjhf/hfr090. Epub 2011 Jul 28.
PubMed 21803755Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
PubMed 3897551Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
PubMed 10965637Sundquist J, Lilja A, Palmer K, Memon AA, Wang X, Johansson LM, Sundquist K. Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry. 2015 Feb;206(2):128-35. doi: 10.1192/bjp.bp.114.150243. Epub 2014 Nov 27.
PubMed 25431430Sundquist J, Palmer K, Johansson LM, Sundquist K. The effect of mindfulness group therapy on a broad range of psychiatric symptoms: A randomised controlled trial in primary health care. Eur Psychiatry. 2017 Jun;43:19-27. doi: 10.1016/j.eurpsy.2017.01.328. Epub 2017 Feb 8.
PubMed 28365464
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness-Based Intervention on Symptoms and Signs, Well-Being and Health in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT04871178
- Acronym / sponsor ID
- Pro Ethical Sweden Dnr 265 10
- Conditions
- Chronic Heart Failure
- Keywords
- Feasibility study, Mindfulness interventions, Fatigue, Anxiety, Depression, Psychological Distress, Well-being, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 10 Oct 2010 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Care as usual: (i.e. best medical treatment) |
| Mindfulness-Based Intervention | Experimental | Behavioral: Mindfulness-based interventionCare as usual (i.e. best medical treatment) in combination with an eight-week mindfulness-based educational and training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionAlso: MBIEight, 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. | Behavioural | Mindfulness-Based Intervention |
Primary outcome
Self-reported impact of fatigue
Time frame: 10 weeks
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.
6 secondary outcomes
Anxiety
Time frame: 10 weeks
Depression
Time frame: 10 weeks
Psychological and General Well-Being
Time frame: 10 weeks
Sense of coherence
Time frame: 10 weeks
Health
Time frame: 10 weeks
Self-reported symptoms of impaired sleep
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 27207191Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
- Background: PubMed 24863749Paren P, Schaufelberger M, Bjorck L, Lappas G, Fu M, Rosengren A. Trends in prevalence from 1990 to 2007 of patients hospitalized with heart failure in Sweden. Eur J Heart Fail. 2014 Jul;16(7):737-42. doi: 10.1002/ejhf.109. Epub 2014 May 26.
- Background: PubMed 15916924Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.
- Background: PubMed 16939845Barnes S, Gott M, Payne S, Parker C, Seamark D, Gariballa S, Small N. Prevalence of symptoms in a community-based sample of heart failure patients. J Pain Symptom Manage. 2006 Sep;32(3):208-16. doi: 10.1016/j.jpainsymman.2006.04.005.
- Background: PubMed 16831569Falk K, Swedberg K, Gaston-Johansson F, Ekman I. Fatigue is a prevalent and severe symptom associated with uncertainty and sense of coherence in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2007 Jun;6(2):99-104. doi: 10.1016/j.ejcnurse.2006.05.004. Epub 2006 Jul 10.
- Background: PubMed 21510771Janssen DJ, Spruit MA, Uszko-Lencer NH, Schols JM, Wouters EF. Symptoms, comorbidities, and health care in advanced chronic obstructive pulmonary disease or chronic heart failure. J Palliat Med. 2011 Jun;14(6):735-43. doi: 10.1089/jpm.2010.0479. Epub 2011 Apr 21.
- Background: PubMed 20033905Yohannes AM, Willgoss TG, Baldwin RC, Connolly MJ. Depression and anxiety in chronic heart failure and chronic obstructive pulmonary disease: prevalence, relevance, clinical implications and management principles. Int J Geriatr Psychiatry. 2010 Dec;25(12):1209-21. doi: 10.1002/gps.2463.
- Background: PubMed 25774841Wu JR, Lennie TA, Frazier SK, Moser DK. Health-Related Quality of Life, Functional Status, and Cardiac Event-Free Survival in Patients With Heart Failure. J Cardiovasc Nurs. 2016 May-Jun;31(3):236-44. doi: 10.1097/JCN.0000000000000248.
- Background: PubMed 10814621Steptoe A, Mohabir A, Mahon NG, McKenna WJ. Health related quality of life and psychological wellbeing in patients with dilated cardiomyopathy. Heart. 2000 Jun;83(6):645-50. doi: 10.1136/heart.83.6.645.
- Background: PubMed 17928476Falk K, Granger BB, Swedberg K, Ekman I. Breaking the vicious circle of fatigue in patients with chronic heart failure. Qual Health Res. 2007 Oct;17(8):1020-7. doi: 10.1177/1049732307306914.
- Background: PubMed 21803755Ekman I, Kjellstrom B, Falk K, Norman J, Swedberg K. Impact of device-guided slow breathing on symptoms of chronic heart failure: a randomized, controlled feasibility study. Eur J Heart Fail. 2011 Sep;13(9):1000-5. doi: 10.1093/eurjhf/hfr090. Epub 2011 Jul 28.
- Background: PubMed 3897551Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985 Jun;8(2):163-90. doi: 10.1007/BF00845519.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
RecruitingObservational study
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
Heart Failure, Chronic Heart Failure
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena M Björck Associate Professor, PhD, RN principal investigator
Göteborg University
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Chronic Heart Failure, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported impact of fatigue (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871178, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.