Back to resultsCBT to Treat Depression in Renal Patients (CBTRPat)
Primary Purpose
Depression, End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, End stage renal disease, Quality of Life, Cognitive Behavioral Therapy
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
Sites / Locations
- Priscila Silveira DuarteRecruiting
Outcomes
Primary Outcome Measures
Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI)
Secondary Outcome Measures
Kidney Disease and Quality of Life Short-form (KDQOL-SF)
Full Information
NCT ID
NCT00530296
First Posted
September 14, 2007
Last Updated
September 14, 2007
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00530296
Brief Title
CBT to Treat Depression in Renal Patients
Acronym
CBTRPat
Official Title
Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, End Stage Renal Disease
Keywords
Depression, End stage renal disease, Quality of Life, Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Group therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course"
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priscila S Duarte, MA
Phone
55-17-3231 5660
Email
psduarte@nefro.epm.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila S. Duarte, MA
Organizational Affiliation
Federal University of Sao Paulo (UNIFESP)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo CS Sesso, PhD
Organizational Affiliation
Federal University of Sao Paulo (UNIFESP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Cristina OS Miyazaki, PhD
Organizational Affiliation
FAMERP Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Priscila Silveira Duarte
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15035-180
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Miyazaki, PhD
Phone
55-17-32015842
Email
cmiyazaki@famerp.br
First Name & Middle Initial & Last Name & Degree
Priscila S Duarte, MA
First Name & Middle Initial & Last Name & Degree
Ricardo CS Sesso, PhD
First Name & Middle Initial & Last Name & Degree
Maria Cristina OS Miyazaki, PhD
12. IPD Sharing Statement
Learn more about this trial
CBT to Treat Depression in Renal Patients
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