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

Not Applicable

• Conditions: End-Stage Renal Disease
• Interventions: Behavioral: Cognitive-behavioral Intervention; Behavioral: CBI and Resilience

• Registration Number: NCT03330938
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2017-12-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-22
• Last Update Posted: 2018-07-24
• Primary Completion: 2018-10-23
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-behavioral Intervention	Cognitive-behavioral Intervention	8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening.
CBI and Resilience	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).	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)

Trial Locations

Locations (1)

Cristina Jazmín Gonzalez Flores; 🇲🇽 Guadalajara, Jalisco, Mexico