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
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
First received: September 14, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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
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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530296

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

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
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

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:
End stage renal disease
Quality of Life
Cognitive Behavioral Therapy

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

ClinicalTrials.gov processed this record on May 26, 2016