Group Psychotherapy Among Congestive Heart Failure Patients

Congestive Heart Failure (CHF) Clinical Trial

Official title:

Group Psychotherapy Among Congestive Heart Failure Patients as a Way to Reduce Psychological Distress and Increase Psycho-social Adjustment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01414439
• Other study ID #: MMC-chf
• Status: Not yet recruiting
• Phase: N/A
• First received: May 2, 2011
• Last updated: August 27, 2011
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2011
• Source: Meir Medical Center
• Contact: Morris Mosseri, Professor
• Phone: 972-9-7472587
• Email: Morris.Mosseri[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical 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. This comparison will be achieved by measuring changes in the variables studied namely, the levels of psychological distress and levels of psycho-social adjustment.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure (CHF)
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Israel	: Department of Cardiology, Meir Medical Center	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Jiang 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 failu — View Citation

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 — View Citation

Konstam 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 — View Citation

Levine 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. — View Citation

O'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. — View Citation

Rumsfeld 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 fai — View Citation

Spiegel D, Classen C. Group therapy for cancer patients. A research-based handbook of psychosocial care. New York: Basic, 2000.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	an expected average of 7 weeks.	No
Secondary	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.	an expected average of 7 weeks.	No