Clinical Trials Directory

Trials / Completed

CompletedNCT06522776

Remote Psychological Intervention for COVID-19 Survivors With AKI and Caregivers (REPICOV-AKI)

Effectiveness of Brief Remote Psychological Intervention for COVID-19 Survivors With Acute Kidney Injury and Their Informal Primary Caregivers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Jesus Rivero, MD · Other Government
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The frequency of psychological conditions in recovered COVID-19 patients with Acute Kidney Injury (AKI) and their informal primary caregivers (IPC) is unknown; as well as the effects of psychological therapy in this population. The present study was initiated to determine the effectiveness of a brief remote psychological intervention (BRPI) to reduce anxious and depressive symptoms in survivors of AKI. The investigator designed a single-case experimental design A-B with prospective follow-up. We used the Patient Health Questionnaire-9 (PHQ-9) and the General Anxiety Disorder Scale-7 (GAD-7) to screen for depressive and anxiety symptoms, one week later after hospital discharge. Those with moderate or severe symptoms received cognitive behavioral therapy (CBT) and were evaluated over time with the instruments and daily self-report of symptoms. The statistical analysis was conducted using statistical software.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive behavioral therapyThe investigator adapted the manual of psychological intervention based on Cognitive Behavioral Therapy (CBT) which previously was validated in patients with chronic kidney disease. Patients received CBT using a model of six modules, with a time of 60 minutes for each weekly session. For each module, a skill acquisition criterion was used, to know if the participants were putting the techniques into practice in their daily lives and to know if it was pertinent to move on to the next module. Modules were adapted to the needs of each participant. In consequence, the number of sessions was different for each patient. All participants had a follow-up session one month after they finished the psychological therapy. Additionally, a daily self-record of symptoms perception and a short questionnaire on the usefulness of each technique used were sent daily to the participants via a phone text message.

Timeline

Start date
2021-03-01
Primary completion
2023-12-31
Completion
2024-07-01
First posted
2024-07-26
Last updated
2024-07-26

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT06522776. Inclusion in this directory is not an endorsement.