CBT to Treat Depression in Renal Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

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.

Conditions

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Depression End Stage Renal Disease

Keywords

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Depression End stage renal disease Quality of Life Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Priscila S. Duarte, MA

Role: PRINCIPAL_INVESTIGATOR

Federal University of Sao Paulo (UNIFESP)

Ricardo CS Sesso, PhD

Role: STUDY_CHAIR

Federal University of Sao Paulo (UNIFESP)

Maria Cristina OS Miyazaki, PhD

Role: STUDY_CHAIR

FAMERP Medical School

Locations

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Priscila Silveira Duarte

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Priscila S Duarte, MA

Role: CONTACT

Phone: 55-17-3231 5660

Email: [email protected]

Facility Contacts

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Maria Cristina Miyazaki, PhD

Role: primary

Other Identifiers

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04/08710-8

Identifier Type: -

Identifier Source: org_study_id