CBT to Treat Depression in Renal Patients (CBTRPat)

September 14, 2007 updated by: Federal University of São Paulo

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15035-180
        • Recruiting
        • Priscila Silveira Duarte
        • Contact:
        • Principal Investigator:
          • Priscila S Duarte, MA
        • Sub-Investigator:
          • Ricardo CS Sesso, PhD
        • Sub-Investigator:
          • Maria Cristina OS Miyazaki, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Priscila S. Duarte, MA, Federal University of São Paulo (UNIFESP)
  • Study Chair: Ricardo CS Sesso, PhD, Federal University of São Paulo (UNIFESP)
  • Study Chair: Maria Cristina OS Miyazaki, PhD, FAMERP Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 17, 2007

Study Record Updates

Last Update Posted (Estimate)

September 17, 2007

Last Update Submitted That Met QC Criteria

September 14, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/08710-8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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