ClinicalTrials.gg
Sign In
Status unknownNCT04907903Updated Jul 27, 2022

RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19

An interventional study of internet-based intervention in Psychological Disease, sponsored by Catholic University of the Sacred Heart. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by Catholic University of the Sacred Heart · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.

Read the detailed description

A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).

02

Conditions studied

  • Psychological Disease

Browse trials for

Keywords

  • COVID-19
  • internet-based intervention
  • cognitive-behavioral therapy
03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 128 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.

Browse Catholic University of the Sacred Heart studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years old or over and both gender
  • Italian mother-tongue
  • Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)
  • Internet access and basic informatic ability to navigate the internet platform
  • Must be able to complete a phone interview

Exclusion criteria

Exclusion Criteria:

  • Having severe and mental impairments, psychiatric condition and neurological disorder
  • Not be able to use a computer or do not have internet access
  • Not be able to complete a phone interview
  • Score 15 or more on PHQ-9
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    RinasciMENTE

    Participants will receive the internet-based intervention.

    Other: internet-based intervention

  • No intervention
    Waiting-list

    Participants will no receive the internet-based intervention.

Interventions

  • Otherinternet-based intervention

    Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).

06

What researchers measure

Primary outcomes

  1. Outcome Questionnaire (OQ-45)

    It measures the changes in adult patients thanks to intervention.

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

Secondary outcomes

  1. Perceived stress scale (PSS)

    It evaluates the perceived stress by person

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

  2. Emotional regulation questionnaire (ERQ)

    It measures how respondents regulate their emotions through two dimensions: cognitive revaluation and expressive suppression.

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

  3. Depression Anxiety Stress Scales-Short Version (DASS-21)

    It allows to observe three dimensions (depression, anxiety and stress)

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

  4. Fear of COVID-19 Scale (FCV-19S)

    It evaluates how subjects show fear relative to the recent pandemic of Coronavirus

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

  5. General Self-efficacy Scale (GSES)

    It evaluates the confidence of subjects in their ability to cope with a variety of difficult or stressing situations.

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

  6. World Health Organization Quality of Life (WHOQOL)-BREF

    It detects four dimensions of quality of life: physical health, psychological health, social relations and environment.

    Time frame: Baseline, 2 months follow-up, 12 months follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 2, 2022
  • Informed consent form · Feb 2, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2022; primary completion for Dec 2022, 3 months later.

Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's planned 3 months is below that.

Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2021
First posted
Jun 1, 2021
StartEst.
Sep 1, 2022
Primary completionEst.
Dec 1, 2022
CompletionEst.
Jun 1, 2023
Last update
Jul 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04907903
Lead sponsor
Catholic University of the Sacred Heart
Collaborators
Bar-Ilan University, Israel, Istituto Auxologico Italiano, Linkoeping University, Karolinska Institutet
Responsible party
Vanessa Bertuzzi (PhD Student, Catholic University of the Sacred Heart) — Principal investigator
First posted
Jun 1, 2021
Start date
Sep 1, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Jul 27, 2022

Study contacts

Vanessa Bertuzzi
Contact
vanessa.bertuzzi@unicatt.it
347-4752286

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19 →

Other studies from this sponsor

Catholic University of the Sacred Heart →

Start the discussion