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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06522776
Acronym
REPICOV-AKI
Enrollment
98
Registered
2024-07-26
Start date
2021-03-01
Completion date
2024-07-01
Last updated
2024-07-26

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

Conditions

Acute Kidney Injury, Anxiety, COVID-19, Depressive Symptoms

Brief 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.

Interventions

BEHAVIORALCognitive behavioral therapy

The 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.

Sponsors

Jesus Rivero, MD
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Survivors of severe COVID-19 who had AKI during hospitalization * Informal primary caregivers

Exclusion criteria

* They did not accept to participate in the study * They did not answer three attempted phone calls or text messages making it impossible to complete the intervention.

Design outcomes

Primary

MeasureTime frameDescription
Anxious symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one monthPsychological behavior changes were evaluated by the anxious symptoms score (mild, moderate, and severe) using General Anxiety Disorder Scale-7 (GAD-7).
Depressive symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one monthPsychological behavior changes were evaluated by the depressive symptoms score (mild, moderate, and severe) using the Patient Health Questionnaire-9 (PHQ-9).

Secondary

MeasureTime frameDescription
General perception scale for identifying the utility of each technique used for the management of psychological symptoms.From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one monthThe utility of each technique used for the management of psychological symptoms was evaluated by the general perception scale using a short questionnaire with daily self-record of symptoms perception (0-10 scale).

Countries

Mexico

Outcome results

None listed

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