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

Primary Purpose

End-Stage Renal Disease

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
CBI and Resilience
Cognitive-behavioral Intervention
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Hemodialysis, Resilience, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cristina Jazmín Gonzalez FloresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBI and Resilience

Cognitive-behavioral Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 2, 2017
Last Updated
July 22, 2018
Sponsor
Hospital Civil de Guadalajara
Collaborators
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT03330938
Brief Title
Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease)
Acronym
ESRD
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 23, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara
Collaborators
University of Guadalajara

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Hemodialysis, Resilience, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, randomized clinical trial
Masking
Investigator
Masking Description
Evaluation measures
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBI and Resilience
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive-behavioral Intervention
Arm Type
Active Comparator
Arm Description
8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening.
Intervention Type
Behavioral
Intervention Name(s)
CBI and Resilience
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral Intervention
Other Intervention Name(s)
CBI
Intervention Description
Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).
Primary Outcome Measure Information:
Title
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).
Description
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)
Time Frame
From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina González, Master
Phone
3310411636
Email
crisjaz_10@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Martha Meda, PhD
Phone
3310411636
Email
estrellita020686@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Martha Meda, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristina Jazmín Gonzalez Flores
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo García, PhD
Phone
3310411636
Email
crisjaz_10@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28114133
Citation
Chan L, Tummalapalli SL, Ferrandino R, Poojary P, Saha A, Chauhan K, Nadkarni GN. The Effect of Depression in Chronic Hemodialysis Patients on Inpatient Hospitalization Outcomes. Blood Purif. 2017;43(1-3):226-234. doi: 10.1159/000452750. Epub 2017 Jan 24.
Results Reference
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PubMed Identifier
27663114
Citation
Chan R, Dear BF, Titov N, Chow J, Suranyi M. Examining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial. J Psychosom Res. 2016 Oct;89:78-84. doi: 10.1016/j.jpsychores.2016.08.012. Epub 2016 Aug 29.
Results Reference
background
PubMed Identifier
19455196
Citation
Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20.
Results Reference
background
PubMed Identifier
26444835
Citation
Wang JL, Zhang DJ, Zimmerman MA. RESILIENCE THEORY AND ITS IMPLICATIONS FOR CHINESE ADOLESCENTS. Psychol Rep. 2015 Oct;117(2):354-75. doi: 10.2466/16.17.PR0.117c21z8. Epub 2015 Oct 7.
Results Reference
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PubMed Identifier
28098100
Citation
John MM, Gupta A, Sharma RK, Kaul A. Impact of residual renal function on clinical outcome and quality of life in patients on peritoneal dialysis. Saudi J Kidney Dis Transpl. 2017 Jan-Feb;28(1):30-35. doi: 10.4103/1319-2442.198109.
Results Reference
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PubMed Identifier
27435635
Citation
Lerma A, Perez-Grovas H, Bermudez L, Peralta-Pedrero ML, Robles-Garcia R, Lerma C. Brief cognitive behavioural intervention for depression and anxiety symptoms improves quality of life in chronic haemodialysis patients. Psychol Psychother. 2017 Mar;90(1):105-123. doi: 10.1111/papt.12098. Epub 2016 Jul 20.
Results Reference
background
PubMed Identifier
27124466
Citation
Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.
Results Reference
background
PubMed Identifier
22809005
Citation
Zalai D, Szeifert L, Novak M. Psychological distress and depression in patients with chronic kidney disease. Semin Dial. 2012 Jul;25(4):428-38. doi: 10.1111/j.1525-139X.2012.01100.x.
Results Reference
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Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease)

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