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Status unknownNCT03330938ESRDUpdated Jul 24, 2018

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

An interventional study of CBI and Resilience and Cognitive-behavioral Intervention in End-Stage Renal Disease, sponsored by Hospital Civil de Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Hospital Civil de Guadalajara · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • End-Stage Renal Disease

Keywords

  • Hemodialysis
  • Resilience
  • Cognitive Behavioral Therapy
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • May not be able to communicate in the Spanish language.
  • Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralCBI 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).

  • BehavioralCognitive-behavioral Intervention

    Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).

    Also known as: CBI

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: From Baseline, at 8 weeks for the intervention phase, and 5 weeks of following.

06

Study locations

1 of 1 sites recruiting
  • Cristina Jazmín Gonzalez Flores
    Guadalajara, Jalisco 44280, Mexico
    Recruiting
07

References and documents

Publications

  • 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. PubMed 28114133 ↗
  • 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. PubMed 27663114 ↗
  • 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. PubMed 19455196 ↗
  • 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. PubMed 26444835 ↗
  • 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. PubMed 28098100 ↗
  • 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. PubMed 27435635 ↗
  • 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. PubMed 27124466 ↗
  • 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. PubMed 22809005 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03330938
Lead sponsor
Hospital Civil de Guadalajara
Collaborators
University of Guadalajara
Responsible party
Cristina Jazmin Gonzalez Flores (Principal Investigator, Hospital Civil de Guadalajara) — Principal investigator
First posted
Nov 6, 2017
Start date
Dec 1, 2017
Primary completion
Oct 23, 2018 (estimated)
Completion
Dec 30, 2018 (estimated)
Last update
Jul 24, 2018

Study contacts

Cristina González, Master
Contact
crisjaz_10@hotmail.com
3310411636
Rosa Martha Meda, PhD
Contact
estrellita020686@gmail.com
3310411636
Rosa Martha Meda, PhD
principal investigator · University of Guadalajara

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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