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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03330938
Recruitment Status : Unknown
Verified July 2018 by Cristina Jazmin Gonzalez Flores, Hospital Civil de Guadalajara.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : July 24, 2018
University of Guadalajara
Information provided by (Responsible Party):
Cristina Jazmin Gonzalez Flores, 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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Behavioral: CBI and Resilience Behavioral: Cognitive-behavioral Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, parallel, randomized clinical trial
Masking: Single (Investigator)
Masking Description: Evaluation measures
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03330938

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Contact: Cristina González, Master 3310411636
Contact: Rosa Martha Meda, PhD 3310411636

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Cristina Jazmín Gonzalez Flores Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Guillermo García, PhD    3310411636   
Sponsors and Collaborators
Hospital Civil de Guadalajara
University of Guadalajara
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Principal Investigator: Rosa Martha Meda, PhD University of Guadalajara

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Responsible Party: Cristina Jazmin Gonzalez Flores, Principal Investigator, Hospital Civil de Guadalajara Identifier: NCT03330938    
Other Study ID Numbers: p3wkkbgz
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cristina Jazmin Gonzalez Flores, Hospital Civil de Guadalajara:
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency