Group Psychotherapy Among Congestive Heart Failure Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2011 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01414439
First received: May 2, 2011
Last updated: August 27, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Congestive Heart Failure (CHF)
Behavioral: Existential Group Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Group Psychotherapy Among Congestive Heart Failure Patients as a Way to Reduce Psychological Distress and Increase Psycho-social Adjustment

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Symptoms of Emotional Distress [ Time Frame: an expected average of 7 weeks. ] [ Designated as safety issue: No ]
    Symptoms of Emotional Distress: The BSI questionnaire (The Brief Symptom Inventory), measuring levels of depression, anxiety and somatization of the subject, will be used.


Secondary Outcome Measures:
  • Patients' Psychosocial adjustment [ Time Frame: an expected average of 7 weeks. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Existential 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.
Other Names:
  • group therapy
  • Supportive-Expressive Group Therapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients diagnosed with heart failure disorder at levels III and IV

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414439

Contacts
Contact: Morris Mosseri, Professor 972-9-7472587 Morris.Mosseri@clalit.org.il
Contact: Noa Vilchinsky, Ph.D : 972-3-531-8601 noav18@inter.net.il

Locations
Israel
: Department of Cardiology, Meir Medical Center Recruiting
Kefar Saba, Israel
Contact: : Morris : Mosseri, Professor    972-9-7472587    Morris.Mosseri@clalit.org.il   
Contact: Noa Vilchinsky, Ph.D    972-3-531-8601    noav18@inter.net.il   
Principal Investigator: : Morris Mosseri, : Professor         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Morris Mosseri, Professor Department of Cardiology, Meir Medical Center, Israel
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01414439     History of Changes
Other Study ID Numbers: MMC-chf
Study First Received: May 2, 2011
Last Updated: August 27, 2011
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014