CBT to Treat Depression in Renal Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, End Stage Renal Disease

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy|Group therapy, 12 sessions (90 minutes each, one session per week) manual Coping with depression course|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, End stage renal disease, Quality of Life, Cognitive Behavioral Therapy