NCT03330938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

August 2, 2017

Last Update Submit

July 22, 2018

Conditions

End-Stage Renal Disease

Keywords

HemodialysisResilienceCognitive Behavioral Therapy

Outcome Measures

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)

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

Study Arms (2)

CBI and Resilience

EXPERIMENTAL

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

Cognitive-behavioral Intervention

ACTIVE COMPARATOR

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

Behavioral: Cognitive-behavioral Intervention

Interventions

CBI and ResilienceBEHAVIORAL

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).

CBI and Resilience
Cognitive-behavioral InterventionBEHAVIORAL

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

Also known as: CBI
Cognitive-behavioral Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Jazmín Gonzalez Flores

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Related Publications (8)

  • 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.

    PMID: 28114133BACKGROUND

  • 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.

    PMID: 27663114BACKGROUND

  • 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.

    PMID: 19455196BACKGROUND

  • 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.

    PMID: 26444835BACKGROUND

  • 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.

    PMID: 28098100BACKGROUND

  • 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.

    PMID: 27435635BACKGROUND

  • 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.

    PMID: 27124466BACKGROUND

  • 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.

    PMID: 22809005BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rosa Martha Meda, PhD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina González, Master

CONTACT

3310411636crisjaz_10@hotmail.com

Rosa Martha Meda, PhD

CONTACT

3310411636estrellita020686@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Evaluation measures
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, parallel, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2017

First Posted

November 6, 2017

Study Start

December 1, 2017

Primary Completion

October 23, 2018

Study Completion

December 30, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

ME(1)