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

July 22, 2018 updated by: Cristina Jazmin Gonzalez Flores, Hospital Civil de Guadalajara

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Cristina Jazmín Gonzalez Flores
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • CBI

What is the study measuring?

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).
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)
From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Collaborators

University of Guadalajara

Investigators

  • Principal Investigator: Rosa Martha Meda, PhD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

October 23, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p3wkkbgz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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