Kidney Failure, ChronicNCT02011139
Cognitive-behavioral (CBT) in ESRD Patients With Depression
A study testing Cognitive-behavioral group therapy in people with Kidney Failure, Chronic and Depression, run by Seoul National University Boramae Hospital at 1 site in South Korea.
Trial summary
Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Depression, Quality of Life
- What is being tested?
- Cognitive-behavioral group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage renal disease : on hemodialysis more than 3 months
- Patients with BDI-II score >= 15 points
- Adult with age >= 20 years old
- Patients who were able to understand and willing to sign the written informed consent
Who cannot join
- Patients on hemodialysis due to acute kidney injury
- Patients who are on admission
- Patients who are undergoing chemotherapy or radiation therapy due to progressive malignant disease
- Patients who are planning kidney transplantation within few months
- Patients with cognitive dysfunction, mental retardation, and drug addict
- Patients who are unavailable for adequate communication with researchers
- Patients who changed anti-depressive agent or dose within 2 months before/after the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients
Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has been little data so far particularly in terms of randomized clinical trials. Here, we investigate the effect of cognitive-behavioral group therapy for enhancing mental health and quality of life in patients with ESRD.
- Conditions
- Kidney Failure, Chronic, Depression, Quality of Life
- Being tested
- Cognitive-behavioral group therapy
- Medical subject headings
- Kidney Failure, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral group therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 12 sessions of Cognitive-behavioral group therapy in the first 12 weeks Receives: Behavioral: Cognitive-behavioral group therapy |
| Group B | Active comparator | 12 sessions of Cognitive-behavioral group therapy in the second 12 weeks Receives: Behavioral: Cognitive-behavioral group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II) score
Measured: 3 months
Secondary outcomes (9)
Secondary assessment tools for depression,anxiety, and quality of life
Hamilton Depression Rating Scale (HAMD-17): assessment for depressive mood
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Beck Anxiety Inventory (BAI)
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
The Perceived Stress Scale
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
KD-QOL: quality of life related with kidney disease
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
WHOQOL_BREF: overall quality of life
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Temperament and Character Inventory (TCI)
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Diagnosis of major depressive disorder by DSM-IV
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Biomarker related with depression: serotonin level and etc.
Measured: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Additional anti-depressant use after trial
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Boramae Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Soo Lim, Seoul National University Boramae Hospital
- Investigators
- Chun Soo Lim, M.D. PhD, Principal investigator, Seoul National University Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011139
- Sponsor's protocol ID
- CBT-ESRD
- Status last verified
- Nov 2015
- First submitted
- 3 Dec 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive-behavioral Group Therapy for Enhancing Mental Health and Quality of Life in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02011139
- Acronym / sponsor ID
- CBT-ESRD
- Conditions
- Kidney Failure, Chronic, Depression, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seoul National University Boramae HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Dec 2013 (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.
Depression is common in end-stage renal disease (ESRD) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. However, it is hard to use anti-depressant due to the safety issue, and there has been little data so far particularly in terms of randomized clinical trials. Here, we investigate the effect of cognitive-behavioral group therapy for enhancing mental health and quality of life in patients with ESRD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Cognitive-behavioral group therapy12 sessions of Cognitive-behavioral group therapy in the first 12 weeks |
| Group B | Active comparator | Behavioral: Cognitive-behavioral group therapy12 sessions of Cognitive-behavioral group therapy in the second 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with end-stage renal disease : on hemodialysis more than 3 months
- Patients with BDI-II score >= 15 points
- Adult with age >= 20 years old
- Patients who were able to understand and willing to sign the written informed consent
Key exclusion criteria (7 listed)
- Patients on hemodialysis due to acute kidney injury
- Patients who are on admission
- Patients who are undergoing chemotherapy or radiation therapy due to progressive malignant disease
- Patients who are planning kidney transplantation within few months
- Patients with cognitive dysfunction, mental retardation, and drug addict
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 group therapy | Behavioural | Group A, Group B |
Primary outcome
Beck Depression Inventory-II (BDI-II) score
Time frame: 3 months
9 secondary outcomes
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Secondary assessment tools for depression,anxiety, and quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Related trials for Kidney Failure, Chronic
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
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.
Chun Soo Lim, M.D. PhD principal investigator
Seoul National University Boramae Hospital
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 group therapy in people with Kidney Failure, Chronic and Depression, run by Seoul National University Boramae Hospital at 1 site in South Korea.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 20 Nov 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (BDI-II) score (time frame: 3 months). 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 20 Nov 2015.