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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Behavioral: CBI and Resilience
* Behavioral: Cognitive-behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBI and Resilience<br>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<br>* 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).<br>|
| Active Comparator: Cognitive-behavioral Intervention<br>8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening. | Behavioral: Cognitive-behavioral Intervention<br>* Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).<br>* Other names: CBI;|

What is the study measuring?
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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). | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Resilience, Cognitive Behavioral Therapy