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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03330938

Acronym

ESRD

Enrollment

Registered

2017-11-06

Start date

2017-12-01

Completion date

2018-12-30

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease

Keywords

Hemodialysis, Resilience, Cognitive Behavioral Therapy

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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Evaluation measures

Intervention model description

Prospective, parallel, randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life Perception (change is being assessed from baseline depression, at 8 weeks and after 5 weeks).	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)

Countries

Mexico

Contacts

Primary ContactCristina González, Master

crisjaz_10@hotmail.com3310411636

Backup ContactRosa Martha Meda, PhD

estrellita020686@gmail.com3310411636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026