ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03330938
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
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.


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
Estimated 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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT03330938


Contacts
Contact: Cristina González, Master 3310411636 crisjaz_10@hotmail.com
Contact: Rosa Martha Meda, PhD 3310411636 estrellita020686@gmail.com

Locations
Mexico
Cristina Jazmín Gonzalez Flores Not yet recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Guillermo García, PhD    3310411636    crisjaz_10@hotmail.com   
Sponsors and Collaborators
Hospital Civil de Guadalajara
University of Guadalajara
Investigators
Principal Investigator: Rosa Martha Meda, PhD University of Guadalajara

Publications:

Responsible Party: Cristina Jazmin Gonzalez Flores, Principal Investigator, Hospital Civil de Guadalajara
ClinicalTrials.gov Identifier: NCT03330938     History of Changes
Other Study ID Numbers: p3wkkbgz
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Hemodialysis
Resilience
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Kidney Diseases
Kidney Failure, Chronic
Behavioral Symptoms
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency