CBT to Treat Depression in Renal Patients

Depression Clinical Trial

— CBTRPat  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00530296
• Other study ID #: 04/08710-8
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2007
• Last updated: September 14, 2007
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: September 2007
• Source: Federal University of São Paulo
• Contact: Priscila S Duarte, MA
• Phone: 55-17-3231 5660
• Email: psduarte[@]nefro.epm.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of HealthBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Group therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course"

Locations

Country	Name	City	State
Brazil	Priscila Silveira Duarte	Sao Jose do Rio Preto	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI)		Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)
Secondary	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)