- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330938
Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease) (ESRD)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cristina González, Master
- Phone Number: 3310411636
- Email: crisjaz_10@hotmail.com
Study Contact Backup
- Name: Rosa Martha Meda, PhD
- Phone Number: 3310411636
- Email: estrellita020686@gmail.com
Study Locations
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Recruiting
- Cristina Jazmín Gonzalez Flores
-
Contact:
- Guillermo García, PhD
- Phone Number: 3310411636
- Email: crisjaz_10@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- May not be able to communicate in the Spanish language.
- Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBI and Resilience
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.
|
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).
|
Active Comparator: Cognitive-behavioral Intervention
8 sessions total, once a week, 2 hours long each.
Cognitive-behavioral Intervention (CBI) without resilience strengthening.
|
Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rosa Martha Meda, PhD, University of Guadalajara
Publications and helpful links
General 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.
- Chan 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.
- Duarte 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.
- Wang 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.
- John 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.
- Lerma 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.
- Matzka 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.
- Zalai 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p3wkkbgz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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