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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Other | 8-sessions psychotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of completion rate | On the basis of previous studies, ≥80% of participants are expected to complete the battery of online self-reports | 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 | 2 years |
| Reported side effects | On the basis of previous findings, zero side effects are expected. | 2 years |
| Program completion rate | About 70% of participants are expected to complete the study. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Improvement in mental wellbeing according to , the Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Brambilla | Università degli Studi di Milano, Fondazione Policlinico di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paolo Brambilla | Milan | Italy | 20100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36228130 | Derived | 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. |
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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). |
| 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). | 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). | 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). | 2 years |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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