Congestive Heart Failure (CHF)NCT01414439
Group Psychotherapy Among Congestive Heart Failure Patients
An observational study of Congestive Heart Failure (CHF), run by Meir Medical Center at 1 site in Israel.
Trial summary
This study will examine the efficacy of group therapy utilizing the Existential Approach in heart failure patients when compared to a control group of patients who are waiting for the same group treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure (CHF)
- What is being tested?
- Existential Group Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients diagnosed with heart failure disorder at levels III and IV
Who may be able to join
- Clinical diagnosis of heart failure at levels III and IV, according to the classification of the NYHA (New York Heart Association) for 3 months or more.
- Clinical diagnosis of LVEF less than 50% or were on diuretic therapy for more than three months with at least one previous hospitalization due to heart failure disease.
Who cannot join
- uncertain prognosis for 12 months due to other conditions.
- acute coronary disease in recent months.
- existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure).
- severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy).
- severe mental illness (active psychosis / suicide risk / severe dementia).
- linguistic limitations (such as misunderstanding of the Hebrew language / stuttering / untreated audio impairment).
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- a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities).
- objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict).
- subjects whose mother tongue is not Hebrew.
Trial locations and contacts
1 site in 1 country.
Israel1 site
: Department of Cardiology, Meir Medical Center
Kfar Saba
: Morris : Mosseri, Professor, 972-9-7472587, Morris.Mosseri@clalit.org.il
Noa Vilchinsky, Ph.D, 972-3-531-8601, noav18@inter.net.il
About this study
Official title: Group Psychotherapy Among Congestive Heart Failure Patients as a Way to Reduce Psychological Distress and Increase Psycho-social Adjustment
This study will examine the efficacy of group therapy utilizing the Existential Approach in heart failure patients when compared to a control group of patients who are waiting for the same group treatment. This comparison will be achieved by measuring changes in the variables studied namely, the levels of psychological distress and levels of psycho-social adjustment.
Read the detailed description
Among all medical conditions, patients with heart failure report significantly poorer quality of life than do the other patients (1). The existing literature describes a wide range of negative emotions common among patients with heart failure; these include everything from depression, anxiety, submission and helplessness to a profound sense of "discord and brokenness." The prevalence of depression, ranging from 11% to 25% among heart disease outpatients and 35% to 70% among those who are hospitalized (2). By comparison, the overall percentage of the population suffering from depression is about 6.6%. Psychological depression appears to be an important predictor of rehospitalization among persons who have been admitted with coronary artery disease (3). In addition, depression in patients with heart failure was found to be associated with the course of the disease and its prognosis. For example, it was found that in patients with heart failure, a diagnosis of Major Depression was correlated with a higher rate of mortality (4), and depressive symptoms predicted short-term worsening of heart failure symptoms (5). The reduction in quality of life that was also found to be common in patients with heart failure is also a prognostic factor for repeated hospitalizations and death (6).
The high prevalence of distress among the population of patients with heart failure, along with the broad impact on the patient's quality of life, requires attention to detail and the implementation of interventions aimed at reducing levels of distress. Very few studies describe interventions aimed at alleviating distress in patients with heart failure. Cognitive Behavioral Therapy is reported to improve both the functional and emotional levels of these patients, resulting in the relief of their symptoms of depression. Using relaxation, Bio-Feedback devices have also achieved a reduction in depression of heart failure patients. Research testing the efficacy of psychological treatment using the interpersonal approach now is being performed; it is funded by the U.S. NIMH and is, at present, in the initial recruitment stages (National Institute of Mental Health, 2010). Studies examining the beneficial effects of group therapy are few in number and most of them utilize a Cognitive Behavioral approach. This therapeutic orientation has been found to be effective when the disease is moderate or the prognosis is favorable. However, outcomes tend to differ greatly when it comes to patients in advanced stages of the condition. These patients are also confronted with fundamental aspects of their own mortality. A large body of literature about psychological interventions for these patients exists. Many of these interventions are based on an Existential Approach aimed at facilitating responses to the unique distress of patients in an advanced stage of the disease (7).
This study examines the contribution of a group therapy program based on the Existential Approach aimed at reducing distress in patients with heart failure.
- Conditions
- Congestive Heart Failure (CHF)
- Being tested
- Existential Group Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Existential Group TherapyBehavioural
Also called group therapy, Supportive-Expressive Group Therapy
The treatment will be given in two groups of eight to ten participants each one and will consist of one hour weekly sessions over a period of seven weeks. Dividing the subjects into small groups allows reference to all members of the group. The group facilitators will be two psychologists who work in co therapy.
| Study group | Role | What they receive |
|---|---|---|
| Congestive Heart Failure Patients | 40 patients diagnosed with heart failure at levels III and IV, according to the classification of the NYHA will participate in the research. The researchers will randomly allocate the patients to the treatment group or the control group. The subjects in the treatment group will participate in Existential Group Therapy, while the subjects in the control group will not participate in the treatment until after the completion of the study. Psychological data will be collected in the form of a self-reported questionnaire completed by all participants prior to the beginning of the research and again upon completion of the final group session. Receives: Behavioral: Existential Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of Emotional Distress
Symptoms of Emotional Distress: The BSI questionnaire (The Brief Symptom Inventory), measuring levels of depression, anxiety and somatization of the subject, will be used.
Measured: an expected average of 7 weeks.
Secondary outcomes (1)
Patients' Psychosocial adjustment
Patients' Psychosocial adjustment: The PAIS-SR questionnaire (Psychological Adjustment to Illness Scale-Self Report), will be used. This questionnaire reflects the patient's adjustment in such areas as employment and leisure activities.
Measured: an expected average of 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart Failure (CHF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Mosseri, Professor, Principal investigator, Department of Cardiology, Meir Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414439
- Sponsor's protocol ID
- MMC-chf
- Status last verified
- Aug 2011
- First submitted
- 2 May 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Juenger J, Schellberg D, Kraemer S, Haunstetter A, Zugck C, Herzog W, Haass M. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002 Mar;87(3):235-41. doi: 10.1136/heart.87.3.235.
PubMed 11847161O'Connor CM, Joynt KE. Depression: are we ignoring an important comorbidity in heart failure? J Am Coll Cardiol. 2004 May 5;43(9):1550-2. doi: 10.1016/j.jacc.2004.02.003. No abstract available.
PubMed 15120810Levine JB, Covino NA, Slack WV, Safran C, Safran DB, Boro JE, Davis RB, Buchanan GM, Gervino EV. Psychological predictors of subsequent medical care among patients hospitalized with cardiac disease. J Cardiopulm Rehabil. 1996 Mar-Apr;16(2):109-16. doi: 10.1097/00008483-199603000-00005.
PubMed 8681155Jiang W, Alexander J, Christopher E, Kuchibhatla M, Gaulden LH, Cuffe MS, Blazing MA, Davenport C, Califf RM, Krishnan RR, O'Connor CM. Relationship of depression to increased risk of mortality and rehospitalization in patients with congestive heart failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.
PubMed 11493126Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.
PubMed 14642693Konstam V, Salem D, Pouleur H, Kostis J, Gorkin L, Shumaker S, Mottard I, Woods P, Konstam MA, Yusuf S. Baseline quality of life as a predictor of mortality and hospitalization in 5,025 patients with congestive heart failure. SOLVD Investigations. Studies of Left Ventricular Dysfunction Investigators. Am J Cardiol. 1996 Oct 15;78(8):890-5. doi: 10.1016/s0002-9149(96)00463-8.
PubMed 8888661Spiegel D, Classen C. Group therapy for cancer patients. A research-based handbook of psychosocial care. New York: Basic, 2000.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Psychotherapy Among Congestive Heart Failure Patients as a Way to Reduce Psychological Distress and Increase Psycho-social Adjustment
- ClinicalTrials.gov ID
- NCT01414439
- Acronym / sponsor ID
- MMC-chf
- Conditions
- Congestive Heart Failure (CHF)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- 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.
This study will examine the efficacy of group therapy utilizing the Existential Approach in heart failure patients when compared to a control group of patients who are waiting for the same group treatment. This comparison will be achieved by measuring changes in the variables studied namely, the levels of psychological distress and levels of psycho-social adjustment.
Detailed description
Among all medical conditions, patients with heart failure report significantly poorer quality of life than do the other patients (1). The existing literature describes a wide range of negative emotions common among patients with heart failure; these include everything from depression, anxiety, submission and helplessness to a profound sense of "discord and brokenness." The prevalence of depression, ranging from 11% to 25% among heart disease outpatients and 35% to 70% among those who are hospitalized (2). By comparison, the overall percentage of the population suffering from depression is about 6.6%. Psychological depression appears to be an important predictor of rehospitalization among persons who have been admitted with coronary artery disease (3). In addition, depression in patients with heart failure was found to be associated with the course of the disease and its prognosis. For example, it was found that in patients with heart failure, a diagnosis of Major Depression was correlated with a higher rate of mortality (4), and depressive symptoms predicted short-term worsening of heart failure symptoms (5). The reduction in quality of life that was also found to be common in patients with heart failure is also a prognostic factor for repeated hospitalizations and death (6).
The high prevalence of distress among the population of patients with heart failure, along with the broad impact on the patient's quality of life, requires attention to detail and the implementation of interventions aimed at reducing levels of distress. Very few studies describe interventions aimed at alleviating distress in patients with heart failure. Cognitive Behavioral Therapy is reported to improve both the functional and emotional levels of these patients, resulting in the relief of their symptoms of depression. Using relaxation, Bio-Feedback devices have also achieved a reduction in depression of heart failure patients. Research testing the efficacy of psychological treatment using the interpersonal approach now is being performed; it is funded by the U.S. NIMH and is, at present, in the initial recruitment stages (National Institute of Mental Health, 2010). Studies examining the beneficial effects of group therapy are few in number and most of them utilize a Cognitive Behavioral approach. This therapeutic orientation has been found to be effective when the disease is moderate or the prognosis is favorable. However, outcomes tend to differ greatly when it comes to patients in advanced stages of the condition. These patients are also confronted with fundamental aspects of their own mortality. A large body of literature about psychological interventions for these patients exists. Many of these interventions are based on an Existential Approach aimed at facilitating responses to the unique distress of patients in an advanced stage of the disease (7).
This study examines the contribution of a group therapy program based on the Existential Approach aimed at reducing distress in patients with heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congestive Heart Failure Patients | – | Behavioral: Existential Group Therapy40 patients diagnosed with heart failure at levels III and IV, according to the classification of the NYHA will participate in the research. The researchers will randomly allocate the patients to the treatment group or the control group. The subjects in the treatment group will participate in Existential Group Therapy, while the subjects in the control group will not participate in the treatment until after the completion of the study. Psychological data will be collected in the form of a self-reported questionnaire completed by all participants prior to the beginning of the research and again upon completion of the final group session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with heart failure disorder at levels III and IV
Key inclusion criteria (2 listed)
- Clinical diagnosis of heart failure at levels III and IV, according to the classification of the NYHA (New York Heart Association) for 3 months or more.
- Clinical diagnosis of LVEF less than 50% or were on diuretic therapy for more than three months with at least one previous hospitalization due to heart failure disease.
Key exclusion criteria (9 listed)
- uncertain prognosis for 12 months due to other conditions.
- acute coronary disease in recent months.
- existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure).
- severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy).
- severe mental illness (active psychosis / suicide risk / severe dementia).
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 |
|---|---|---|
| Existential Group TherapyAlso: group therapy, Supportive-Expressive Group TherapyThe treatment will be given in two groups of eight to ten participants each one and will consist of one hour weekly sessions over a period of seven weeks. Dividing the subjects into small groups allows reference to all members of the group. The group facilitators will be two psychologists who work in co therapy. | Behavioural | Congestive Heart Failure Patients |
Primary outcome
Symptoms of Emotional Distress
Time frame: an expected average of 7 weeks.
Symptoms of Emotional Distress: The BSI questionnaire (The Brief Symptom Inventory), measuring levels of depression, anxiety and somatization of the subject, will be used.
1 secondary outcome
Patients' Psychosocial adjustment
Time frame: an expected average of 7 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
- Results publication: PubMed 11847161Juenger J, Schellberg D, Kraemer S, Haunstetter A, Zugck C, Herzog W, Haass M. Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables. Heart. 2002 Mar;87(3):235-41. doi: 10.1136/heart.87.3.235.
- Results publication: PubMed 15120810O'Connor CM, Joynt KE. Depression: are we ignoring an important comorbidity in heart failure? J Am Coll Cardiol. 2004 May 5;43(9):1550-2. doi: 10.1016/j.jacc.2004.02.003. No abstract available.
- Results publication: PubMed 8681155Levine JB, Covino NA, Slack WV, Safran C, Safran DB, Boro JE, Davis RB, Buchanan GM, Gervino EV. Psychological predictors of subsequent medical care among patients hospitalized with cardiac disease. J Cardiopulm Rehabil. 1996 Mar-Apr;16(2):109-16. doi: 10.1097/00008483-199603000-00005.
- Results publication: PubMed 11493126Jiang W, Alexander J, Christopher E, Kuchibhatla M, Gaulden LH, Cuffe MS, Blazing MA, Davenport C, Califf RM, Krishnan RR, O'Connor CM. Relationship of depression to increased risk of mortality and rehospitalization in patients with congestive heart failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.
- Results publication: PubMed 14642693Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA; Cardiovascular Outcomes Research Consortium. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.
- Results publication: PubMed 8888661Konstam V, Salem D, Pouleur H, Kostis J, Gorkin L, Shumaker S, Mottard I, Woods P, Konstam MA, Yusuf S. Baseline quality of life as a predictor of mortality and hospitalization in 5,025 patients with congestive heart failure. SOLVD Investigations. Studies of Left Ventricular Dysfunction Investigators. Am J Cardiol. 1996 Oct 15;78(8):890-5. doi: 10.1016/s0002-9149(96)00463-8.
- Results publicationSpiegel D, Classen C. Group therapy for cancer patients. A research-based handbook of psychosocial care. New York: Basic, 2000.
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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.
Morris Mosseri, Professor principal investigator
Department of Cardiology, Meir Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure (CHF), run by Meir Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morris Mosseri, Professor (972-9-7472587, Morris.Mosseri@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Emotional Distress (time frame: an expected average of 7 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 NCT01414439, which also lists 7 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 30 Aug 2011.