Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease)

End-Stage Renal Disease Clinical Trial

— ESRD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330938
• Other study ID #: p3wkkbgz
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2018
• Source: Hospital Civil de Guadalajara
• Contact: Cristina González, Master
• Phone: 3310411636
• Email: crisjaz_10[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• CBI and Resilience
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 Intervention
Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).

Locations

Country	Name	City	State
Mexico	Cristina Jazmín Gonzalez Flores	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara	University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lerma A, Perez-Grovas H, Bermudez L, Peralta-Pedrero ML, Robles-García 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. — View Citation

Matzka M, Mayer H, Köck-Hódi 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.