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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

September 14, 2007
September 14, 2007
June 2005
Not Provided
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) ]
Same as current
No Changes Posted
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) ]
Same as current
Not Provided
Not Provided
 
CBT to Treat Depression in Renal Patients
Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Depression
  • End Stage Renal Disease
Behavioral: Cognitive Behavioral Therapy
Group therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course"
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2008
Not Provided

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
Both
18 Years to 80 Years
No
Contact: Priscila S Duarte, MA 55-17-3231 5660 psduarte@nefro.epm.br
Brazil
 
NCT00530296
04/08710-8
No
Not Provided
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
Federal University of São Paulo
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP