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Completed

NCT Number: NCT06522776

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

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.

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Key information

Conditions

COVID-19 Acute Kidney Injury Anxiety Anxiety Disorders Behavior Behavioral Symptoms Coronaviridae Infections Coronavirus Infections Depression Depressive Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

Primary outcomes

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

    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

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

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

    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

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

Secondary outcomes

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

    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

    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).

Sponsors and collaborators

Lead sponsor

Jesus Rivero, MD

Other Gov

Registry information

Official study title

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

Acronym: REPICOV-AKI

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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