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CompletedNCT06522776REPICOV-AKIUpdated Jul 26, 2024

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

An interventional study of Cognitive behavioral therapy in COVID-19, Anxiety and Depressive Symptoms, sponsored by Jesus Rivero, MD. Completed at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-26.

Sponsored by Jesus Rivero, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19
  • Anxiety
  • Depressive Symptoms
  • Acute Kidney Injury
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 98 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Jesus Rivero, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Remote cognitive behavioral therapy

    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.

    Behavioral: Cognitive behavioral therapy

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.

06

What researchers measure

Primary outcomes

  1. Anxious symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.

    Psychological behavior changes were evaluated by the anxious symptoms score (mild, moderate, and severe) using General Anxiety Disorder Scale-7 (GAD-7).

    Time frame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month

  2. Depressive symptoms score for identifying changes in psychological behavior before and after to brief remote psychological intervention.

    Psychological behavior changes were evaluated by the depressive symptoms score (mild, moderate, and severe) using the Patient Health Questionnaire-9 (PHQ-9).

    Time frame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month

Secondary outcomes

  1. General perception scale for identifying the utility of each technique used for the management of psychological symptoms.

    The 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).

    Time frame: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month

07

Study locations

1 site
  • National Institute of Respiratory Diseases
    Mexico City, Ciudad DE México 14080, Mexico
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06522776
Lead sponsor
Jesus Rivero, MD
Responsible party
Jesus Rivero, MD (MD, Instituto Nacional de Enfermedades Respiratorias) — Sponsor-investigator
First posted
Jul 26, 2024
Start date
Mar 1, 2021
Primary completion
Dec 31, 2023
Completion
Jul 1, 2024
Last update
Jul 26, 2024

Study contacts

Jesús Rivero, MD
principal investigator · INER

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 completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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