COVID-19DigiCOVIDNCT05231018
A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization.
A study testing Psychotherapy in people with COVID-19 and Mental Health Impairment, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
This study presents a digital mental-health protocol designed to offer remote, personalized support to former or current COVID-19 patients. A total of 100 subjects will be enrolled. Participation is voluntary, and an extended informed-consent form is signed before any evaluation, assessment or voice/video call. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Mental Health Impairment, Telemedicine
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2020to 31 Dec 2022
- 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
- Age 18-80
- A positive COVID-19 test at the moment of enrolment for subjects in the 'patients' group
- Adequate sensory and motor abilities, without impairments in vision, hearing and handling devices
- Access to Internet wireless technologies.
- A good level of Italian in terms of speaking, reading and writing.
Who cannot join
- Present of past medical history of schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, current substance abuse, all according to the diagnostic and statistical manual fifth edition (DSM-5) (American Psychiatric Association, 2013).
- With a diagnosis of cognitive impairment and/or dementia (e.g., mild cognitive impairment, Alzheimer's disease, Parkinson's disease);
- Intellectual disability defined by a total IQ < 70 in Test di Intelligenza Breve (TIB) (Sartori et al., 1997) or Standard Progressive Raven Matrices (John \& Raven, 2003)
- Severe present medical conditions that could interfere with participation.
- Present or past suicidal ideation or commitment.
- Significant impairment in the use of digital and technological devices, in questionnaires and test completions, comprehension or with lack of a compliant behavior in the earliest evaluations.
- Being enrolled in other clinical trials assessing any psychological, or experimental pharmacological treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Feasibility and Efficacy of a Telepsychiatric Approach for or COVID19+ Patients, with Particular Attention to Neurocognitive Evaluations and Clinical Questionnaires, Administered Remotely Before and and After Our Treatment Plan.
This study presents a digital mental-health protocol designed to offer remote, personalized support to former or current COVID-19 patients.
A total of 100 subjects will be enrolled. Participation is voluntary, and an extended informed-consent form is signed before any evaluation, assessment or voice/video call. Consent forms are collected remotely for those who have been discharged and are currently in remission and in-person for subjects hospitalized in a COVID-19-ward of either pneumology, internal medicine or infectious disease departments.
Read more
Efforts will be made to assess all participants who have completed the minimum required intervention activities: for DigiCOVID, minimum required intervention activities include attending psychotherapy sessions at least 4 times. As the main goal of this project is to evaluate the feasibility, acceptability and usability of DigiCOVID, the investigators will conduct an analysis of the following primary outcome measures in all ITT participants:
- Assessment of completion rate. Based on our previous studies, the investigators expect that ≥80% of participants will complete the battery of online self-reports:
- Usability ratings obtained post-DigiCOVID via a 7-point Likert-scale questionnaire (mean rating of all responses). This is a brief and embedded post-study questionnaire on program satisfaction, clarity, and perceived benefits. Participants will rate each sentence on the following 7-point Likert scale: 1 = Completely Agree; 2 = Mostly Agree; 3 = Somewhat Agree; 4 = Undecided; 5 = Somewhat Disagree; 6 = Mostly Disagree; 7 = Completely Disagree. Based on our previous studies, the investigators hypothesize exit survey ratings of at least ≥4.5 ±1.5 on the 7-point Likert scale items;
- Reported side effects (raw score). Based on our previous findings, the investigators expect 0 adverse events due to program use;
- Overall program completion rate. Based on previous findings, the investigators hypothesize full program completion in ≥70% study participants.
The secondary outcome measures will be collected at baseline and immediately after the treatment for all participants. The investigators designed DigiCOVID to improve mental wellbeing. Therefore, the investigators will measure the impact of the intervention by looking at pre-post changes in the following outcome measures: the General Health Questionnaire (GHQ-12) (Goldberg, 1988) , the Impact of Event Scale-Revised (IES-R) (Weiss \& Marmar, 1997), the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006), the Insomnia Severity Index (ISI) (Morin et al., 2011), and the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001). The investigators expect to observe a significant improvement across all these secondary outcome measures in COVID-19 patients. To verify these experimental hypotheses, the investigators will conduct the analysis based on the pre-intervention (baseline) and post-intervention data using parametric and non parametric statistical tests. The criterion for statistical significance is p < 0.05. Results with p < 0.1 will be described as trends.
- Conditions
- COVID-19, Mental Health Impairment, Telemedicine
- Being tested
- Psychotherapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
8-sessions psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | The population of interest includes COVID-19 patients previously or currently hospitalized at the Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, according to inclusion and exclusion criteria. Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of completion rate
On the basis of previous studies, ≥80% of participants are expected to complete the battery of online self-reports
Measured: 2 years
Usability ratings obtained post-DigiCOVID via a 7-point Likert-scale questionnaire
General feasibility tested with a brief and embedded post-study questionnaire on program satisfaction, clarity, and perceived benefits
Measured: 2 years
Reported side effects
On the basis of previous findings, zero side effects are expected.
Measured: 2 years
Program completion rate
About 70% of participants are expected to complete the study.
Measured: 2 years
Secondary outcomes (5)
Improvement in mental wellbeing according to the General Health Questionnaire (GHQ-12) (Goldberg, 1988)
Measurements of the impact of the intervention by looking at pre-post changes in the General Health Questionnaire (GHQ-12) (Goldberg, 1988).
Measured: 2 years
Improvement in mental wellbeing according to , the Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997)
Measurements of the impact of the intervention by looking at pre-post changes in the Impact of Event Scale-Revised (IES-R) (Weiss \& Marmar, 1997).
Measured: 2 years
Improvement in mental wellbeing according to the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006)
Measurements of the impact of the intervention by looking at pre-post changes in the the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006).
Measured: 2 years
Improvement in mental wellbeing according to the Insomnia Severity Index (ISI) (Morin et al., 2011)
Measurements of the impact of the intervention by looking at pre-post changes in the the Insomnia Severity Index (ISI) (Morin et al., 2011).
Measured: 2 years
Improvement in mental wellbeing according to the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001).
Measurements of the impact of the intervention by looking at pre-post changes in the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start28 Oct 2020
- Primary completion1 Dec 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Brambilla, Principal investigator, Università degli Studi di Milano, Fondazione Policlinico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231018
- Sponsor's protocol ID
- DigiCOVID
- Acronym
- DigiCOVID
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cantu F, Biagianti B, Lisi I, R Zanier E, Bottino N, Fornoni C, Gallo F, Ginex V, Tombola V, Zito S, Colombo E, Stocchetti N, Brambilla P. Psychotherapeutic and Psychiatric Intervention in Patients With COVID-19 and Their Relatives: Protocol for the DigiCOVID Trial. JMIR Res Protoc. 2022 Nov 16;11(11):e39080. doi: 10.2196/39080.
PubMed 36228130
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Feasibility and Efficacy of a Telepsychiatric Approach for or COVID19+ Patients, with Particular Attention to Neurocognitive Evaluations and Clinical Questionnaires, Administered Remotely Before and and After Our Treatment Plan.
- ClinicalTrials.gov ID
- NCT05231018
- Acronym / sponsor ID
- DigiCOVID / DigiCOVID
- Conditions
- COVID-19, Mental Health Impairment, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Feb 2022 (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.
This study presents a digital mental-health protocol designed to offer remote, personalized support to former or current COVID-19 patients.
A total of 100 subjects will be enrolled. Participation is voluntary, and an extended informed-consent form is signed before any evaluation, assessment or voice/video call. Consent forms are collected remotely for those who have been discharged and are currently in remission and in-person for subjects hospitalized in a COVID-19-ward of either pneumology, internal medicine or infectious disease departments.
Efforts will be made to assess all participants who have completed the minimum required intervention activities: for DigiCOVID, minimum required intervention activities include attending psychotherapy sessions at least 4 times. As the main goal of this project is to evaluate the feasibility, acceptability and usability of DigiCOVID, the investigators will conduct an analysis of the following primary outcome measures in all ITT participants:
- Assessment of completion rate. Based on our previous studies, the investigators expect that ≥80% of participants will complete the battery of online self-reports:
- Usability ratings obtained post-DigiCOVID via a 7-point Likert-scale questionnaire (mean rating of all responses). This is a brief and embedded post-study questionnaire on program satisfaction, clarity, and perceived benefits. Participants will rate each sentence on the following 7-point Likert scale: 1 = Completely Agree; 2 = Mostly Agree; 3 = Somewhat Agree; 4 = Undecided; 5 = Somewhat Disagree; 6 = Mostly Disagree; 7 = Completely Disagree. Based on our previous studies, the investigators hypothesize exit survey ratings of at least ≥4.5 ±1.5 on the 7-point Likert scale items;
- Reported side effects (raw score). Based on our previous findings, the investigators expect 0 adverse events due to program use;
- Overall program completion rate. Based on previous findings, the investigators hypothesize full program completion in ≥70% study participants.
The secondary outcome measures will be collected at baseline and immediately after the treatment for all participants. The investigators designed DigiCOVID to improve mental wellbeing. Therefore, the investigators will measure the impact of the intervention by looking at pre-post changes in the following outcome measures: the General Health Questionnaire (GHQ-12) (Goldberg, 1988) , the Impact of Event Scale-Revised (IES-R) (Weiss \& Marmar, 1997), the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006), the Insomnia Severity Index (ISI) (Morin et al., 2011), and the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001). The investigators expect to observe a significant improvement across all these secondary outcome measures in COVID-19 patients. To verify these experimental hypotheses, the investigators will conduct the analysis based on the pre-intervention (baseline) and post-intervention data using parametric and non parametric statistical tests. The criterion for statistical significance is p < 0.05. Results with p < 0.1 will be described as trends.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Other: PsychotherapyThe population of interest includes COVID-19 patients previously or currently hospitalized at the Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, according to inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- A positive COVID-19 test at the moment of enrolment for subjects in the 'patients' group
- Adequate sensory and motor abilities, without impairments in vision, hearing and handling devices
- Access to Internet wireless technologies.
- A good level of Italian in terms of speaking, reading and writing.
Key exclusion criteria (7 listed)
- Present of past medical history of schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, current substance abuse, all according to the diagnostic and statistical manual fifth edition (DSM-5) (American Psychiatric Association, 2013).
- With a diagnosis of cognitive impairment and/or dementia (e.g., mild cognitive impairment, Alzheimer's disease, Parkinson's disease);
- Intellectual disability defined by a total IQ < 70 in Test di Intelligenza Breve (TIB) (Sartori et al., 1997) or Standard Progressive Raven Matrices (John \& Raven, 2003)
- Severe present medical conditions that could interfere with participation.
- Present or past suicidal ideation or commitment.
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 |
|---|---|---|
| Psychotherapy8-sessions psychotherapy | Other | Psychotherapy |
Primary outcome
Assessment of completion rate
Time frame: 2 years
On the basis of previous studies, ≥80% of participants are expected to complete the battery of online self-reports
Usability ratings obtained post-DigiCOVID via a 7-point Likert-scale questionnaire
Time frame: 2 years
General feasibility tested with a brief and embedded post-study questionnaire on program satisfaction, clarity, and perceived benefits
Reported side effects
Time frame: 2 years
On the basis of previous findings, zero side effects are expected.
Program completion rate
Time frame: 2 years
About 70% of participants are expected to complete the study.
5 secondary outcomes
Improvement in mental wellbeing according to the General Health Questionnaire (GHQ-12) (Goldberg, 1988)
Time frame: 2 years
Improvement in mental wellbeing according to , the Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997)
Time frame: 2 years
Improvement in mental wellbeing according to the General Anxiety Disorder-7 (GAD-7) (Robert L Spitzer et al., 2006)
Time frame: 2 years
Improvement in mental wellbeing according to the Insomnia Severity Index (ISI) (Morin et al., 2011)
Time frame: 2 years
Improvement in mental wellbeing according to the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001).
Time frame: 2 years
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 27 Dec 2024.
- Derived from this study: PubMed 36228130Cantu F, Biagianti B, Lisi I, R Zanier E, Bottino N, Fornoni C, Gallo F, Ginex V, Tombola V, Zito S, Colombo E, Stocchetti N, Brambilla P. Psychotherapeutic and Psychiatric Intervention in Patients With COVID-19 and Their Relatives: Protocol for the DigiCOVID Trial. JMIR Res Protoc. 2022 Nov 16;11(11):e39080. doi: 10.2196/39080.
- Individual participant dataSharing planned: Undecided
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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.
Paolo Brambilla principal investigator
Università degli Studi di Milano, Fondazione Policlinico di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with COVID-19 and Mental Health Impairment, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 5 inclusion and 7 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 27 Dec 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 Italy. 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?
Assessment of completion rate (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231018, which also lists 1 linked publication.
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 27 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.