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Clinical Trials/NCT03330938
NCT03330938
Unknown
Not Applicable

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

Hospital Civil de Guadalajara1 site in 1 country50 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Renal Disease
Sponsor
Hospital Civil de Guadalajara
Enrollment
50
Locations
1
Primary Endpoint
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
December 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Jazmin Gonzalez Flores

Principal Investigator

Hospital Civil de Guadalajara

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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)

Study Sites (1)

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