A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization.

NCT05231018 | Completed

• 1 other identifier: DigiCOVID
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Assessment of completion rate. Based on our previous studies, the investigators expect that ≥80% of participants will complete the battery of online self-reports:
2. 2.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;
3. 3.Reported side effects (raw score). Based on our previous findings, the investigators expect 0 adverse events due to program use;
4. 4.Overall program completion rate. Based on previous findings, the investigators hypothesize full program completion in ≥70% study participants.

Conditions

COVID-19; Mental Health Impairment; Telemedicine

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Improvement in mental wellbeing according to 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)

  2 years

• Improvement in mental wellbeing according to 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)

  2 years

• Improvement in mental wellbeing according to the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001).

  2 years

Study Arms (1)

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.

Other: Psychotherapy

Interventions

Psychotherapy OTHER

8-sessions psychotherapy

Psychotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Paolo Brambilla

Milan, Italy, 20100, Italy

Location

Related Publications (1)

• 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.

  PMID: 36228130 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Psychotherapy

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

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Paolo Brambilla

  Università degli Studi di Milano, Fondazione Policlinico di Milano

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 9, 2022
• Study Start: October 28, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-11

Locations

IT (1)