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Clinical Trials/NCT00530296
NCT00530296
Unknown
N/A

Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression

Federal University of São Paulo1 site in 1 country80 target enrollmentJune 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Federal University of São Paulo
Enrollment
80
Locations
1
Primary Endpoint
Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI)
Last Updated
18 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
June 2008
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Kidney Disease and Quality of Life Short-form (KDQOL-SF)(Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention))

Study Sites (1)

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