COVID-19REPICOV-AKINCT06522776
Remote Psychological Intervention for COVID-19 Survivors With AKI and Caregivers (REPICOV-AKI)
A study testing Cognitive behavioral therapy in people with COVID-19 and Anxiety, run by Jesus Rivero, MD at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Anxiety, Depressive Symptoms
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors of severe COVID-19 who had AKI during hospitalization
- Informal primary caregivers
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Respiratory Diseases
Mexico City, Mexico City, 14080
About this study
Official title: Effectiveness of Brief Remote Psychological Intervention for COVID-19 Survivors With Acute Kidney Injury and Their Informal Primary Caregivers
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
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- COVID-19, Anxiety Disorders, Depression, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: From the date of one week later after hospital discharge at the hospital until the date of the end intervention, in average one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesus Rivero, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jesus Rivero, MD, Instituto Nacional de Enfermedades Respiratorias
- Investigators
- Jesús Rivero, MD, Principal investigator, INER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522776
- Sponsor's protocol ID
- C34-21
- Acronym
- REPICOV-AKI
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Brief Remote Psychological Intervention for COVID-19 Survivors With Acute Kidney Injury and Their Informal Primary Caregivers
- ClinicalTrials.gov ID
- NCT06522776
- Acronym / sponsor ID
- REPICOV-AKI / C34-21
- Conditions
- COVID-19, Anxiety, Depressive Symptoms, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jesus Rivero, MDOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapyA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Survivors of severe COVID-19 who had AKI during hospitalization
- Informal primary caregivers
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive 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. | Behavioural | Remote cognitive behavioral therapy |
Primary outcome
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).
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús Rivero, MD principal investigator
INER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with COVID-19 and Anxiety, run by Jesus Rivero, MD at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.