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
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.
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | : Department of Cardiology, Meir Medical Center | Kefar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
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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.
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 |
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