NCT01414439

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

3.3 years

First QC Date

May 2, 2011

Last Update Submit

August 27, 2011

Conditions

Congestive Heart Failure (CHF)

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Patients' Psychosocial adjustment

    an expected average of 7 weeks.

Study Arms (1)

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

Interventions

Existential Group TherapyBEHAVIORAL

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.

Also known as: group therapy, Supportive-Expressive Group Therapy
Congestive Heart Failure Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with heart failure disorder at levels III and IV

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

: Department of Cardiology, Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (7)

  • 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.

    PMID: 11847161RESULT

  • 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. doi: 10.1016/j.jacc.2004.02.003. No abstract available.

    PMID: 15120810RESULT

  • 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. doi: 10.1097/00008483-199603000-00005.

    PMID: 8681155RESULT

  • 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 failure. Arch Intern Med. 2001 Aug 13-27;161(15):1849-56. doi: 10.1001/archinte.161.15.1849.

    PMID: 11493126RESULT

  • 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 failure. J Am Coll Cardiol. 2003 Nov 19;42(10):1811-7. doi: 10.1016/j.jacc.2003.07.013.

    PMID: 14642693RESULT

  • 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 of Left Ventricular Dysfunction Investigators. Am J Cardiol. 1996 Oct 15;78(8):890-5. doi: 10.1016/s0002-9149(96)00463-8.

    PMID: 8888661RESULT

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

    RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Morris Mosseri, Professor

    Department of Cardiology, Meir Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morris Mosseri, Professor

CONTACT

972-9-7472587Morris.Mosseri@clalit.org.il

Noa Vilchinsky, Ph.D

CONTACT

: 972-3-531-8601noav18@inter.net.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

IL(1)