Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease) (ESRD)
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|ClinicalTrials.gov Identifier: NCT03330938|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease||Behavioral: CBI and Resilience Behavioral: Cognitive-behavioral Intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, parallel, randomized clinical trial|
|Masking Description:||Evaluation measures|
|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|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||October 23, 2018|
|Estimated Study Completion Date :||December 30, 2018|
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.
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).
Active Comparator: Cognitive-behavioral Intervention
8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening.
Behavioral: Cognitive-behavioral Intervention
Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).
Other Name: CBI
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330938
|Contact: Cristina González, Masterfirstname.lastname@example.org|
|Contact: Rosa Martha Meda, PhDemail@example.com|
|Cristina Jazmín Gonzalez Flores||Recruiting|
|Guadalajara, Jalisco, Mexico, 44280|
|Contact: Guillermo García, PhD 3310411636 firstname.lastname@example.org|
|Principal Investigator:||Rosa Martha Meda, PhD||University of Guadalajara|