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CBT to Treat Depression in Renal Patients (CBTRPat)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00530296
First received: September 14, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

The purpose of this study is to determine whether Cognitive Behavioral Therapy is effective in the treatment of depression in patients with end-stage renal disease in hemodialysis therapy


Condition Intervention
Depression
End Stage Renal Disease
 Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI) [ Time Frame: Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention) ]

Secondary Outcome Measures:
  • Kidney Disease and Quality of Life Short-form (KDQOL-SF) [ Time Frame: Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention) ]

Estimated Enrollment: 80
Study Start Date: June 2005
Estimated Study Completion Date: June 2008
Intervention Details:
    Behavioral: Cognitive Behavioral Therapy
    Group therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course"
Detailed Description:

Depression is a persistent problem among patients with end-stage renal disease and it does not tend to improve over time. The implementation of effective interventions to treat and prevent recurrence of depressive episodes is needed. The objectives of this study are: 1)the detection of Major Depression in hemodialysis patients; 2)to allocate patients with depression in two groups: structured program of treatment with CBT (group therapy)and control group (conventional psychotherapy at the dialysis unit); and 3)to verify whether after 3 months of CBT there was a remission of depressive symptoms and a improvement of the quality of life in the CBT group.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of Chronic renal disease (end stage) in hemodialysis for at least 3 months
  • Diagnosis of Major depression disorder (4 or more clinical criteria in MINI and a BDI score of 10 or more)

Exclusion Criteria:

  • Patients in process of renal transplant with (living donor)
  • Psychiatric comorbidity
  • Cognitive impairment or mental retardation
  • Current substance abuse
  • Heart failure, angina pectoris, arrhythmias
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530296

Contacts
Contact: Priscila S Duarte, MA 55-17-3231 5660 psduarte@nefro.epm.br

Locations
Brazil
Priscila Silveira Duarte Recruiting
Sao Jose do Rio Preto, Sao Paulo, Brazil, 15035-180
Contact: Maria Cristina Miyazaki, PhD     55-17-32015842     cmiyazaki@famerp.br    
Principal Investigator: Priscila S Duarte, MA            
Sub-Investigator: Ricardo CS Sesso, PhD            
Sub-Investigator: Maria Cristina OS Miyazaki, PhD            
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Priscila S. Duarte, MA Federal University of Sao Paulo (UNIFESP)
Study Chair: Ricardo CS Sesso, PhD Federal University of Sao Paulo (UNIFESP)
Study Chair: Maria Cristina OS Miyazaki, PhD FAMERP Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00530296     History of Changes
Other Study ID Numbers: 04/08710-8
Study First Received: September 14, 2007
Last Updated: September 14, 2007
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Depression
End stage renal disease
Quality of Life
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Kidney Diseases
Kidney Failure, Chronic
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013