NCT00530296

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 17, 2007

Status Verified

September 1, 2007

First QC Date

September 14, 2007

Last Update Submit

September 14, 2007

Conditions

DepressionEnd Stage Renal Disease

Keywords

DepressionEnd stage renal diseaseQuality of LifeCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients in process of renal transplant with (living donor)
  • Psychiatric comorbidity
  • Cognitive impairment or mental retardation
  • Current substance abuse
  • Heart failure, angina pectoris, arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Priscila Silveira Duarte

São José do Rio Preto, São Paulo, 15035-180, Brazil

RECRUITING

MeSH Terms

Conditions

DepressionKidney Failure, Chronic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Priscila S. Duarte, MA

    Federal University of Sao Paulo (UNIFESP)

    PRINCIPAL INVESTIGATOR

  • Ricardo CS Sesso, PhD

    Federal University of Sao Paulo (UNIFESP)

    STUDY CHAIR

  • Maria Cristina OS Miyazaki, PhD

    FAMERP Medical School

    STUDY CHAIR

Central Study Contacts

Priscila S Duarte, MA

CONTACT

55-17-3231 5660psduarte@nefro.epm.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 17, 2007

Study Start

June 1, 2005

Study Completion

June 1, 2008

Last Updated

September 17, 2007

Record last verified: 2007-09

Locations

BR(1)