DepressionCBTRPatNCT00530296
CBT to Treat Depression in Renal Patients
A study testing Cognitive Behavioral Therapy in people with Depression and End Stage Renal Disease, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression, End Stage Renal Disease
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2005to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients in process of renal transplant with (living donor)
- Psychiatric comorbidity
- Cognitive impairment or mental retardation
- Current substance abuse
- Heart failure, angina pectoris, arrhythmias
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Priscila Silveira Duarte
São José do Rio Preto, São Paulo, 15035-180
Maria Cristina Miyazaki, PhD, 55-17-32015842, cmiyazaki@famerp.br
Priscila S Duarte, MA
About this study
Official title: 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
Read the 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.
- Conditions
- Depression, End Stage Renal Disease
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Depression, End stage renal disease, Quality of Life, Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Group therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course"
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini International Neuropsychiatric Interview (MINI-DSM-IV) Beck Depression Inventory (BDI)
Measured: 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)
Measured: Baseline; 3 months (end of intervention); follow-up (6 months after the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJun 2005
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Priscila S. Duarte, MA, Principal investigator, Federal University of Sao Paulo (UNIFESP)Ricardo CS Sesso, PhD, Study chair, Federal University of Sao Paulo (UNIFESP)Maria Cristina OS Miyazaki, PhD, Study chair, FAMERP Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530296
- Sponsor's protocol ID
- 04/08710-8
- Acronym
- CBTRPat
- Status last verified
- Sep 2007
- First submitted
- 14 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Therapy in Patients With End-Stage Renal Disease in Hemodialysis and With Depression
- ClinicalTrials.gov ID
- NCT00530296
- Acronym / sponsor ID
- CBTRPat / 04/08710-8
- Conditions
- Depression, End Stage Renal Disease
- Keywords
- Depression, End stage renal disease, Quality of Life, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2005
- Study completion
- Jun 2008 (estimated)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- Patients in process of renal transplant with (living donor)
- Psychiatric comorbidity
- Cognitive impairment or mental retardation
- Current substance abuse
- Heart failure, angina pectoris, arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyGroup therapy, 12 sessions (90 minutes each, one session per week) manual "Coping with depression course" | Behavioural | – |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priscila S. Duarte, MA principal investigator
Federal University of Sao Paulo (UNIFESP)
Ricardo CS Sesso, PhD study chair
Federal University of Sao Paulo (UNIFESP)
Maria Cristina OS Miyazaki, PhD study chair
FAMERP Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Depression and End Stage Renal Disease, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priscila S Duarte, MA (55-17-3231 5660, psduarte@nefro.epm.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2007.