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

NCT06522776 | Completed DMC

• 1 other identifier: C34-21
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

  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.

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

Study Arms (1)

Remote cognitive behavioral therapy

EXPERIMENTAL

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

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.

Remote cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jesus Rivero, MD: lead

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Depression; Acute Kidney Injury

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jesús Rivero, MD

  INER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 26, 2024
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)