End-Stage Renal DiseaseESRDNCT03330938
Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease)
A study testing CBI and Resilience and Cognitive-behavioral Intervention in people with End-Stage Renal Disease, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- CBI and Resilience and Cognitive-behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2017to 30 Dec 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Older than 18, and younger than 61 years old
- Depression score in the Beck Depression Inventory (BDI) greater than 30 points.
- Anxiety score in the Beck Anxiety Inventory (BAI) greater than 40 points.
- Have not been hospitalized over the last 6 months
- Signing of informed consent
Who cannot join
- May not be able to communicate in the Spanish language.
- Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Cristina Jazmín Gonzalez Flores
Guadalajara, Jalisco, 44280
Guillermo García, PhD, 3310411636, crisjaz_10@hotmail.com
About this study
Official title: Randomized Controlled Trial to Evaluate the Effect of a Cognitive Behavioral Program and Resilient Model in the Treatment of Depression and Anxiety and Impact on the Quality of Life in End-Stage Renal Disease Patients
This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients.
Read the detailed description
Cognitive behavioral therapy has long been an alternative in the treatment of symptoms of depression and anxiety in patients with chronic diseases such as renal failure, however the combination of therapeutic approaches that include not only pathological but also another more positive approach (as the resilient model), represents a novel proposal for the treatment of negative psychological symptoms and improvement of the quality of life in these patients.
The inclusion of the resilient model in a cognitive behavioral intervention serves as a possibility of therapeutic target that could enhance the effectiveness of the treatment.
- Conditions
- End-Stage Renal Disease
- Being tested
- CBI and Resilience, Cognitive-behavioral Intervention
- Keywords
- Hemodialysis, Resilience, Cognitive Behavioral Therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBI and ResilienceBehavioural
A combination of CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring) + Resilience strengthening (Identifying resilient strengths and potentialities, plus Imagination and projection into the future).
Cognitive-behavioral InterventionBehavioural
Also called CBI
Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).
| Study group | Role | What they receive |
|---|---|---|
| CBI and Resilience | Experimental | 8 sessions total, once a week, 2 hours long each, consistent of 6 sessions of Cognitive-behavioral Intervention (CBI) plus 2 sessions to improve resilience strengths. Receives: Behavioral: CBI and Resilience |
| Cognitive-behavioral Intervention | Active comparator | 8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening. Receives: Behavioral: Cognitive-behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
Outcome measuring will be held at the baseline, after finishing the intervention (8 weeks), and after a following period of 5 weeks.
Tool: Kidney Disease Quality of life (KDQOL 36)
Measured: From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion23 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for End-Stage Renal DiseaseStudies 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
- Model description
- Prospective, parallel, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guadalajara
- Responsible party
- Principal investigator, Cristina Jazmin Gonzalez Flores, Hospital Civil de Guadalajara
- Investigators
- Rosa Martha Meda, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330938
- Sponsor's protocol ID
- p3wkkbgz
- Acronym
- ESRD
- Status last verified
- Jul 2018
- First submitted
- 2 Aug 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chan L, Tummalapalli SL, Ferrandino R, Poojary P, Saha A, Chauhan K, Nadkarni GN. The Effect of Depression in Chronic Hemodialysis Patients on Inpatient Hospitalization Outcomes. Blood Purif. 2017;43(1-3):226-234. doi: 10.1159/000452750. Epub 2017 Jan 24.
PubMed 28114133Chan R, Dear BF, Titov N, Chow J, Suranyi M. Examining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial. J Psychosom Res. 2016 Oct;89:78-84. doi: 10.1016/j.jpsychores.2016.08.012. Epub 2016 Aug 29.
PubMed 27663114Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20.
PubMed 19455196Wang JL, Zhang DJ, Zimmerman MA. RESILIENCE THEORY AND ITS IMPLICATIONS FOR CHINESE ADOLESCENTS. Psychol Rep. 2015 Oct;117(2):354-75. doi: 10.2466/16.17.PR0.117c21z8. Epub 2015 Oct 7.
PubMed 26444835John MM, Gupta A, Sharma RK, Kaul A. Impact of residual renal function on clinical outcome and quality of life in patients on peritoneal dialysis. Saudi J Kidney Dis Transpl. 2017 Jan-Feb;28(1):30-35. doi: 10.4103/1319-2442.198109.
PubMed 28098100Lerma A, Perez-Grovas H, Bermudez L, Peralta-Pedrero ML, Robles-Garcia R, Lerma C. Brief cognitive behavioural intervention for depression and anxiety symptoms improves quality of life in chronic haemodialysis patients. Psychol Psychother. 2017 Mar;90(1):105-123. doi: 10.1111/papt.12098. Epub 2016 Jul 20.
PubMed 27435635Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.
PubMed 27124466Zalai D, Szeifert L, Novak M. Psychological distress and depression in patients with chronic kidney disease. Semin Dial. 2012 Jul;25(4):428-38. doi: 10.1111/j.1525-139X.2012.01100.x.
PubMed 22809005
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effect of a Cognitive Behavioral Program and Resilient Model in the Treatment of Depression and Anxiety and Impact on the Quality of Life in End-Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT03330938
- Acronym / sponsor ID
- ESRD / p3wkkbgz
- Conditions
- End-Stage Renal Disease
- Keywords
- Hemodialysis, Resilience, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Collaborators
- University of Guadalajara
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 23 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 6 Nov 2017 (actual)
- 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.
This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients.
Detailed description
Cognitive behavioral therapy has long been an alternative in the treatment of symptoms of depression and anxiety in patients with chronic diseases such as renal failure, however the combination of therapeutic approaches that include not only pathological but also another more positive approach (as the resilient model), represents a novel proposal for the treatment of negative psychological symptoms and improvement of the quality of life in these patients.
The inclusion of the resilient model in a cognitive behavioral intervention serves as a possibility of therapeutic target that could enhance the effectiveness of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, parallel, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| CBI and Resilience | Experimental | Behavioral: CBI and Resilience8 sessions total, once a week, 2 hours long each, consistent of 6 sessions of Cognitive-behavioral Intervention (CBI) plus 2 sessions to improve resilience strengths. |
| Cognitive-behavioral Intervention | Active comparator | Behavioral: Cognitive-behavioral Intervention8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Older than 18, and younger than 61 years old
- Depression score in the Beck Depression Inventory (BDI) greater than 30 points.
- Anxiety score in the Beck Anxiety Inventory (BAI) greater than 40 points.
- Have not been hospitalized over the last 6 months
- Signing of informed consent
Key exclusion criteria (2 listed)
- May not be able to communicate in the Spanish language.
- Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
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 |
|---|---|---|
| CBI and ResilienceA combination of CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring) + Resilience strengthening (Identifying resilient strengths and potentialities, plus Imagination and projection into the future). | Behavioural | CBI and Resilience |
| Cognitive-behavioral InterventionAlso: CBIOnly CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring). | Behavioural | Cognitive-behavioral Intervention |
Primary outcome
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
Time frame: From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.
Outcome measuring will be held at the baseline, after finishing the intervention (8 weeks), and after a following period of 5 weeks. Tool: Kidney Disease Quality of life (KDQOL 36)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 28114133Chan L, Tummalapalli SL, Ferrandino R, Poojary P, Saha A, Chauhan K, Nadkarni GN. The Effect of Depression in Chronic Hemodialysis Patients on Inpatient Hospitalization Outcomes. Blood Purif. 2017;43(1-3):226-234. doi: 10.1159/000452750. Epub 2017 Jan 24.
- Background: PubMed 27663114Chan R, Dear BF, Titov N, Chow J, Suranyi M. Examining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial. J Psychosom Res. 2016 Oct;89:78-84. doi: 10.1016/j.jpsychores.2016.08.012. Epub 2016 Aug 29.
- Background: PubMed 19455196Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20.
- Background: PubMed 26444835Wang JL, Zhang DJ, Zimmerman MA. RESILIENCE THEORY AND ITS IMPLICATIONS FOR CHINESE ADOLESCENTS. Psychol Rep. 2015 Oct;117(2):354-75. doi: 10.2466/16.17.PR0.117c21z8. Epub 2015 Oct 7.
- Background: PubMed 28098100John MM, Gupta A, Sharma RK, Kaul A. Impact of residual renal function on clinical outcome and quality of life in patients on peritoneal dialysis. Saudi J Kidney Dis Transpl. 2017 Jan-Feb;28(1):30-35. doi: 10.4103/1319-2442.198109.
- Background: PubMed 27435635Lerma A, Perez-Grovas H, Bermudez L, Peralta-Pedrero ML, Robles-Garcia R, Lerma C. Brief cognitive behavioural intervention for depression and anxiety symptoms improves quality of life in chronic haemodialysis patients. Psychol Psychother. 2017 Mar;90(1):105-123. doi: 10.1111/papt.12098. Epub 2016 Jul 20.
- Background: PubMed 27124466Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.
- Background: PubMed 22809005Zalai D, Szeifert L, Novak M. Psychological distress and depression in patients with chronic kidney disease. Semin Dial. 2012 Jul;25(4):428-38. doi: 10.1111/j.1525-139X.2012.01100.x.
- Individual participant dataSharing planned: Undecided
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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.
Rosa Martha Meda, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBI and Resilience and Cognitive-behavioral Intervention in people with End-Stage Renal Disease, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 5 inclusion and 2 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 24 Jul 2018. 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 Mexico. 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 Cristina González, Master (3310411636, crisjaz_10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks). (time frame: From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330938, which also lists 8 linked publications.
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 24 Jul 2018.