RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to Coronavirus-19: Study Protocol of a Randomized Controlled Trial
Phase: NA
Conditions: Psychological Disease
Sponsor: Catholic University of the Sacred Heart

 
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RinasciMENTE. An Internet-Based Self-Help Intervention to Cope with Psychological Distress 
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Due to COVID-19: A Study Protocol for a Randomized Controlled Trial 
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NCT04907903 
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Version: 02/02/2022 
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ABSTRACT 
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Background This study aims to evaluate the feasibility and effectiveness of the RinasciMENTE 
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program, an Internet-based self-help intervention based on Cognitive Behavioral Therapy (CBT) 
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principles and techniques in supporting individuals experiencing psychological impairments during 
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the COVID-19 pandemic. A randomized controlled trial (RCT) design with random allocation at the 
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level of individual will be conducted to compare the impact of the RinasciMENTE program with a 
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waiting list control in improving the psychological functioning of the general population during the 
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COVID-19 pandemic.  
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Methods A minimum sample of 128 participants experiencing mild/subthreshold levels of 
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psychological symptoms during the COVID-19 pandemic will be recruited. After the initial 
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screening, participants will be randomly assigned to either the experimental group or the control 
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condition. The program will last 2 months, during which participants will receive 8 weekly CBT 
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treatment modules. The impact of the RinasciMENTE program on selected primary and secondary 
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psychological outcomes will be tested at the end of the intervention (2 months), 6- and 12-month 
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follow-up.  
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Discussion We expect people to show an increased level of psychological functioning, and to acquire 
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the skills and self-confidence necessary to deal with the psychological consequences of the COVID-
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19 outbreak and its related social isolation during and following the pandemic. 
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Trial registration ClinicalTrials.gov NCT0497903 Registered on 28 May 2021. 
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Keywords: COVID-19, Internet-based intervention, Self-help, Cognitive-behavioral therapy, 
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Psychological distress, Randomized controlled trial, Clinical psychology. 
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BACKGROUND 
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In the hope of reducing the transmission of Coronavirus Disease 2019 (COVID-19) governments 
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around the world have implemented unprecedentedly strict preventive measures, such as home 
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confinement, mobility restrictions, and social distancing (1, 2). However, the COVID-19 pandemic 
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and the resulting economic recession (3) have negatively affected the mental health of many people 
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(4). The most common mental disorders emerging were anxiety and depression, obsessive-
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compulsive symptoms, insomnia, and post-traumatic stress disorder symptoms (5-9). These were not 
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only a direct consequence of the pandemic but also largely driven by the effects of prolonged social 
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isolation. Although necessary to limit the spread of the epidemic, social isolation resulted in increased 
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sedentary lifestyle (2) and other COVID-19-related stressors including fears of infection, frustration 
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and boredom, and lack of in-person contacts (10, 11). Italy was one of the most affected countries 
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during the outbreak, initially accounting for over 223.000 infected individuals and more than 31.000 
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deaths (12). In May 2021, 4.111.110 people resulted having contracted the virus, and 122.833 of them 
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died as a consequence (13, 14). 
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In this scenario, it is crucial to assess the level of psychological distress and to provide ad hoc 
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psychological interventions to support the individuals’ wellbeing in both the general population (15, 
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16) and at-risk groups (17, 18) during the COVID-19 pandemic.  
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Accordingly, evidence from previous epidemics highlights the risk for long-term mental health issues 
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(19) and emphasizes the need for continued support during and after the pandemic (20). 
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Many health organizations have already committed resources to support the mental well-being of the 
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individuals, adapting existing standard programs to meet evolving demands caused by COVID-19 
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(21). In this regard, cognitive-behavioral techniques including restructuring of cognitive bias, as well 
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as activity planning and relaxation, have been shown particularly useful in addressing psychological 
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distress (22-25). 
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Cognitive-behavioral therapy (CBT) is a time-sensitive, structured, present-oriented psychotherapy 
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aimed at helping people identify and change thinking and behavior patterns that are harmful or 
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ineffective, replacing them with more accurate thoughts and functional behaviors. 
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Still, given that face-to-face treatment is not always viable in these circumstances  (26) a new way to 
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deliver psychological treatments is urgently required, and a potentially practical solution is to deliver 
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therapy remotely (14, 27-30). 
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Many systematic reviews and randomized controlled trials (RCTs) demonstrated the utility and the 
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efficacy of Internet-based interventions in supporting people experiencing psychological problems 
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(31-33).  
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Advantages include improved access for individuals (26) who have variable schedules, an important 
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workload, or who are afraid of being contaminated through face-to-face contacts (34-36), as well as 
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cost-effectiveness compared to face-to-face treatment.  
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Due to its features, CBT well-suits many aspects of distance therapy. First, it is a talking therapy, and 
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this aspect can be relatively easily retained remotely. It also emphasizes the importance of the person 
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making changes and working on specific tasks between sessions to bring about the change (37); this 
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is perfectly consistent with working remotely. Moreover, with distance therapy, the patient may be 
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less likely to attribute the progress to the therapist and more likely to have an improved sense of self-
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efficacy (38). One of the goals of CBT is to "become your therapist" by learning skills people can use 
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on their own after treatment to keep feeling well. 
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Research shows that CBT delivered digitally (iCBT) is effective in reducing symptoms of social 
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anxiety disorder (39, 40), generalized anxiety disorder (41, 42), panic disorder (43), major depressive 
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disorder (44-46), obsessive-compulsive disorder (47) and insomnia (48) in both guided and unguided 
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self-help programs. Specifically, a review of 30 studies found that CBT-based self-help interventions 
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significantly reduced both anxiety and depression. Studies also show that people tend to maintain 
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their progress over time, which is very encouraging (49). Furthermore, since patients can return to 
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the program at their convenience to access treatment information, this may facilitate learning and 
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retention. 
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Despite a growing interest in the field of web-based psychological interventions, Internet-based CBT 
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self-help programs remain underdeveloped.  
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To fill this important gap in the literature and to properly meet the need of the population, it is crucial 
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to promote and investigate the impact of this Internet-based psychological intervention in increasing 
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individuals’ emotional well-being.  
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For this reason, the present RCT aims to explore the effectiveness of a novel Internet-based CBT self-
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help program specifically developed to address the immediate stress and prevent long-term 
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psychological consequences of the COVID-19 pandemic among Italians both living in the county and 
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abroad. To assess its impact, the effects of the RinasciMENTE program will be compared with a 
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waiting list (WL) condition on selected self-reported measures immediately following the 8-week 
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intervention and at 6- and 12-month follow-up.  
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The primary hypothesis that will be tested is that the program will be feasible and effective in 
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increasing the psychological functioning of the person.  
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The secondary hypothesis will test whether participants assigned to the experimental condition will 
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show a reduced level of stress, anxiety, depression, and fear of COVID-19, as well as improved 
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emotion regulation strategies, self-efficacy, and psychological well-being than those in the WL 
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condition at treatment termination.  
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Moreover, participants in the experimental condition will be expected to present maintained outcomes 
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or further decreased psychological symptoms at 6 and 12-month after the end of the treatment 
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program. 
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METHODS 
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Design 
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The project consists of a prospective, randomized, open, and parallel group-controlled study with two 
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arms: an experimental arm with 8 online weekly CBT self-help sessions, and a waiting list (WL) 
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control arm.  
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Ethical Statement 
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The study was approved by the Ethical Committee of the Catholic University of Milan, Italy (ID: 25-
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21). All procedures performed in the study will be run following the ethical standards of the 
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institutional and/or national research committee and with the Helsinki Declaration and its later 
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amendments or comparable ethical standards.  
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Patients and public involvement 
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Participants from the general population will be recruited through advertisements placed on social 
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media platforms (i.e., Facebook, Instagram, Twitter), and online webinars on the topic. 
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The recruitment materials will include details about the study aim, the treatment delivered, and the 
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conditions for participation, together with the weblink to access the program.  
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Inclusion criteria for the participants into the study will be: (A) being fluent in the Italian language; 
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(B) being over 18 years old; (C) providing online informed consent; and (D) showing 
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mild/subthreshold levels of symptoms at the 12-Item General Health Questionnaire (GHQ-12) - 
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Italian version (50, 51) - the most extensively used screening tool assessing the severity of common 
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mental disorders over the past few weeks using a 4-point Likert-type scale (from 0 to 3). Its total 
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score ranges from 0 to 36, with high scores indicating worse health status. Only participants who 
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score ≥ 15 on the GHQ and show moderate levels of symptoms at the clinical interview will be 
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included in the study. 
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Participants will be excluded from the program if: (A) presenting visual, hearing, or cognitive 
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impairments that will prevent them from receiving and following the intervention; (B) suffering from 
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severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders 
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(DSM 5) (52); (C) lacking basic computer skills or internet access.  
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Respondents will not be excluded if already receiving psychopharmacological therapy or 
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psychological-psychotherapeutic support. 
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Sample size calculation 
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The minimum sample size required to conduct this study was calculated using an a priori sample size 
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calculator (G*Power 3.1.9.2 software) for F tests (53-55). Participants were randomly divided into 
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two groups: (A) iCBT self-help and (B) waiting list control. Moreover, participants will be measured 
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in 3 moments: (1) before the intervention, (2) at the end of intervention (two months later), and (3) 
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after 12 months from treatment termination. Due to the novelty of the study from which to derive 
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realistic estimates of effect sizes, the partial η2 was set a priori to assume a value of 0.02 – small 
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effect size (56, 57) – which provides a Cohen’s f value of 0.143. Moreover, the type I error (α) rate 
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was set at 0.05 (two-sided) and the Power (1 – β) was set at 0.95, and the a priori correlation between 
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repeated measures was set at 0.50, according to general guidelines (56). Lastly, the non-sphericity 
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correction was set to 1. Results showed that there is a 95% chance of correctly rejecting the null 
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hypothesis of no significant effect of the interaction with 128 participants in total (64 for each group). 
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Randomization and blinding 
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The random randomization scheme will be generated using the Web site Randomization.com (58). 
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Allocation concealment will be ensured by the program generating an anonymous code for each 
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participant that will be associated with the randomization sequence. Due to the nature of the 
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intervention, the treatment group allocation cannot be concealed from the participants, nor the 
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research team and assessor of outcomes. Participants will be assigned to one of two conditions within 
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2 working days from their baseline assessment (Figure 1). 
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*** PLEASE INSERT Figure 1: Flow chart of the RinasciMENTE study 
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Measures 
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Demographic and clinical information. Information about age, gender, education, civil status, weight, and 
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high - used to calculate the Body Mass Index (BMI, kg/m2) in presence of dysfunctional eating behaviors 
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- will be self-reported online at baseline. Subjects will be also asked to provide information about the 
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country where they are currently living, their work situation (before and after the COVID-19 pandemic), 
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and the personal experience they made of both COVID-19 pandemic and related preventive measures.  
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The Italian version of the following psychological measures will be also collected at baseline (T0), 
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treatment termination after 2 months (T1), at 6-month (T2), and 12-month (T3) follow-up in the 
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experimental condition only). Please see Figure 2 for a detailed project timeline. 
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*** INSERT GANTT Figure 2: Gantt of the RinasciMENTE study 
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Primary outcome:  
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Outcome Questionnaire (OQ-45) (59) composed by 45 items rated on a 5-point Likert scale (0 = Never – 
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4 = Almost always) assessing the treatment progresses across 3 different domains: Symptom Distress (SD 
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– 25 items: 2, 3, 5, 6, 8, 9, 10, 11, 13, 15, 22, 23, 24, 25, 27, 29, 31, 33, 34, 35, 36, 40, 41, 42 and 45), 
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Interpersonal Relations (IR – 11 items: 1, 7, 16, 17, 18, 19, 20, 26, 30, 37 and 43), and Social Role (SR – 
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9 items: 4, 12, 14, 21, 28, 32, 38, 39 and 44). The OQ-45 total score is calculated by summing the score of 
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the three subscales. Total score (range 0 to 180) is calculated by the sum of the items. 
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Secondary outcomes: 
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Perceived stress scale (PSS) (60), composed of 10 items rated on a 5-point Likert scale (from 0 = never to 
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4 = very often) assessing the degree to which situations in one’s life are appraised as stressful. PSS scores 
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are obtained by reversing responses (i.e., 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) to the four positively stated 
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items (items 4, 5, 7, and 8) and then summing across all scale items. The total score (range 0 to 40) is 
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calculated by the sum of the items. 
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Emotional regulation questionnaire (ERQ) (61), composed of 10 items rated on a 7-point Likert scale 
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(from 1 = strongly disagree to 7 = strongly agree) assessing respondents’ tendency to regulate their 
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emotions in two ways: Cognitive Reappraisal (items 1, 3, 5, 7, 8, and 10) and Expressive Suppression 
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(items 2, 4, 6, and 9). The total score (range 7 to 70) is calculated by the sum of the items. 
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Depression Anxiety Stress Scales-Short Version (DASS-21) (62), composed by 21 statements rated on a 
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4-point Likert scale (from 0 = did not apply to me at all to 3 = applied to me very much) assessing the 
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negative emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 
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items: Depression: dysphoria, hopelessness, devaluation of life, self-deprecation, lack of 
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interest/involvement, anhedonia, and inertia - (Items 3, 5, 10, 13, 16, 17, and 21); Anxiety: autonomic 
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arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect - 
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(Items 2, 4, 7, 9, 15, 19, and 20); Stress: levels of chronic nonspecific arousal, difficulty relaxing, 
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nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient - (Items 1, 6, 8, 
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11, 12, 14, and 18). Sum scores are computed by adding up the scores on the items per (sub)scale and 
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multiplying them by 2. Sum scores for the total DASS-total scale thus range between 0 and 126, and 
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those for each of the subscales may range between 0 and 42. Ranges of scores correspond to levels 
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of symptoms, ranging from “normal” to “extremely serious”. Notably, the DASS-21 has been recently 
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used to investigate the impact of the COVID-19 pandemic on the physical and mental health of 
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different populations worldwide (63-65). 
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Fear of COVID-19 Scale (FCV-19S) (66) composed by 7-item rated on a 5-point scale, ranging from 1 
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(from 1 = strongly disagree to 5 = strongly agree) reflecting cognitive, emotional, behavioral, and 
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physiological manifestations of fear related to COVID-19. The total score (range 7 to 35) is calculated by 
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the sum of the items. All items are positively worded, implying that higher scores indicate greater levels of 
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fear.  
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General Self-efficacy Scale (GSES) (67), composed of 10 items rated on a 4-point Likert scale (from 
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1 = Not at all true to 4 = exactly true) assessing the individuals’ confidence in their ability to cope 
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with a variety of difficult or stressing situations. The total score is calculated by finding the sum of 
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all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more 
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self-efficacy. 
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World Health Organization Quality of Life (WHOQOL)-BREF (68), composed of 26 items rated on 
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a 5-point Likert scale assessing four domains: physical health (7 items on mobility, daily activities, 
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functional capacity, energy, pain, and sleep), psychological health (6 items on self-image, negative 
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thoughts, positive attitudes, self-esteem, mentality, learning ability, memory concentration, religion, 
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and the mental status), social relationships (3 items on personal relationships, social support, and sex 
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life), and environmental health (8 items related to financial resources, safety, health, and social 
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services); it also contains QOL and general health items. The scores (range 25 to 130) are transformed 
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linearly to a 0–100-scale. 
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Moreover, adherence will be measured through indicators such as the percentage of visited pages or the 
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number of accesses.  
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Acceptability will be assessed by registering the participants’ attrition rates and – for the experimental 
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group only - by the use of the System Usability Scale (SUS)(69) composed of 10 statements scored 
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on a 5-point Likert scale (from 1 = strongly disagree to 5 = strongly agree). The final score range from 
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0 to 100, with a score above 68 indicating the absence of usability problems. 
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Procedure 
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Those interested in taking part in the program will be directed to the RinasciMENTE website 
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(https://www.iterapi.se/sites/rinascimente/login) where they will find the written (online) consent, 
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and after the acceptance of this, to each participant will be sent a document with information on the 
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aims and requirements of the study.  
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They will be first asked to complete the GHQ-12 self-report questionnaires. Then, during the 
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following 5 days, they will choose a time slot to be contacted for a clinical semi-structured interview 
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lasting about 45 minutes, led by a certified clinical psychotherapist not involved in the study who will 
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further assess the individual’s eligibility to take part in the study. Additional information about the 
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study and the randomization procedure will be also given to all respondents. 
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Next, the inclusion of each participant in the study and modules comprising the program will be 
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discussed in a group by the professional who will conduct the interview and the research investigators 
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(GP and VB), and the decision will be e-mailed to each participant within a week. Reasons for 
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exclusion will be explained to the persons and – in presence of severe psychological disturbance - 
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individuals will be suggested to ask for professional help.  
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Eligible subjects will be then randomly assigned to either the experimental (iCBT self-help) or control 
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group (WL), and will receive an e-mail with a username and a customized link to create their 
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password allowing them to log into the iterapi platform (70, 71). The iterapi is a safe platform with 
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demonstrated efficacy in reducing symptoms of a wide range of disorders including somatic problems 
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- such as hearing loss (72) and tinnitus (73) - to more traditional forms of psychological suffering, 
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such as anxiety (74) and depression (75). 
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Participants in the experimental group will be required to make their first access to the platform and 
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sign an electronic informed consent form within 24 hours, while those in the control condition will 
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be able to access the online treatment once the experimental group will conclude the intervention 
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(after two months). 
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The platform will be used for communication between the mental health professionals and the 
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participants, for the delivery of the intervention, and the quantitative assessments. 
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Before entering the program, participants in the study will have to complete the self-report 
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questionnaires assessing the above selected primary and secondary outcomes (T0).  
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The treatment will consist of 8 weekly modules, for a total duration of 2 months. Seven modules 
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(Introduction, Behavioral activation, Dysfunctional beliefs, Acceptance, Stress management, 
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Problem resolution and Plan of completion and maintenance) will be maintained for all participants, 
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while one module will be selected tailored on the specific psychological needs of each participant. 
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between the following:  (1) Emotional school; (2) Anxiety and exposition; (3) Constant anxiety; (4) 
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Social anxiety; (5) Panic attack; (6) Sleep quality; (7) Perfectionism; (8) Relaxation; (9) Management 
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of difficult memories. The description of each module is reported in Table 1.   
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*** INSERT Table 1: Description of the RinasciMENTE modules  
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For the entire duration of the intervention, every Thursday participants will receive an e-mail 
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communicating the update of the new material on the platform. Participants who will not access the 
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material or that will not complete the suggested tasks and exercises will receive a weekly reminder 
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containing a brief encouraging message every Monday. 
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At the end of the program (after two months – T1), participants in both conditions will be asked to 
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fill in the baseline questionnaires again. Then, the experimental group will be also assessed after 6- 
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and 12 months from the term of the treatment (T2 and T3) (Figure 1).  
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Statistical analysis  
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Statistical analyses were performed using SPSS software ver. 24.0 (76). 
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First, preliminary analyses will be performed to test the assumptions of both univariate and 
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multivariate normality: if (strong) violations will be detected, robust methods or data transformation 
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will be applied. Dropouts will be excluded from the study. 
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A missing values analysis will be run to see if the values are Missing Completely at Random 
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(MCAR), or if there is some pattern among missing data. If there are no patterns detected, then 
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pairwise or listwise deletion will be done to deal with missing data. However, if the missing values 
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analysis detects a pattern, then imputation will be done. 
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The demographic characteristics will be reported as means and standard deviations for continuous 
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variables, and frequencies and percentages for categorical variables. 
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The chi-square statistic will be used to test the association between treatment groups and socio-
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demographic and variables (i.e., age, gender, education, civil status, job), and correlation analysis 
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will be used to test the association between quantitative variables.  
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The outcomes will be compared in the two treatment conditions using an Intention-To-Treat (ITT) 
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approach. The significance level will be set at 5%. 
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A repeated-measures ANOVA will be used to determine whether there are any between and within 
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groups differences  in the selected outcomes from baseline to treatment termination. , Then  repeated-
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measures within group ANOVA will test outcome differences over time baseline, end of treatment, 
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6- and 12-month follow-up) in the experimental group only (. Corrected effect sizes (Cohen’s d) and 
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significance at 95% confidence interval (95% CI) will be calculated for both between-group and 
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within-group differences, while for the total effect will be calculated the Cohen’s f.  
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DISCUSSION 
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To help and mitigate the impact of the COVID-19 pandemic on selected psychological parameters, 
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the objective of this study is to evaluate the effectiveness of an Internet-based self-help intervention 
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based on CBT principles and techniques, in reducing the level of stress, anxiety, depression, and fear 
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of COVID-19, while increasing emotions self-regulation and perceived self-efficacy of Italians both 
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living in the country and abroad. .  
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The online modality was chosen due to the current multiple barriers for face-to-face psychological 
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interventions (i.e., mobility), and its largely acknowledged advantages, including greater flexibility 
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or the possibility to reach rural or low-income population (77), and Italians living outside the country 
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who look for psychological support in their language. Also, the self-help approach to therapy will be 
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employed to further improve access to treatments and empower users to strengthen their self-
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management ability, while putting less strain on therapeutic resources (78) than conventional 
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treatments do. 
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Expected results  
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The results of this RCT will provide evidence for the feasibility and effectiveness of the 
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RinasciMENTE program in supporting the emotional well-being of the persons. Specifically, people 
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are expected to show reduced levels of stress, anxiety, depression, and fear of COVID-19, as well as 
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improved emotion regulation strategies, and self-efficacy. They are also expected to acquire the skills 
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necessary to deal with the psychological consequences of social isolation during and after the 
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COVID-19 outbreak.   
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Still, among the weaknesses of this study, it must be anticipated possible lack of internet access and 
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digital literacy skills of some people.  
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Non-digital natives (i.e., older people) might, indeed, experience difficulties in the use of digital tools, 
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and social isolation can pose additional challenges to their usage (i.e., chaotic home environments, 
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limited privacy, or unreliable internet connection) (79).  
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The use of online intervention might also prevent effective controlling of confounding variables (i.e. 
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environmental factors) that might impact treatment outcomes (80). 
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The results from this study will help to detect and address any usability problem, as Internet-based 
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interventions, due to their characteristics and format, might be a suitable and feasible solution to 
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mitigate the psychological impact of the virus outbreak and its related containment measures on the 
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mental health status of the general population across the lifespan. Moreover, the findings will 
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contribute to the further adaption of the self-help CBT programs. 
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In line with previous research findings, it is possible to predict that dropout rates may be higher with 
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web-based interventions than in traditional face-to-face therapy (80), especially when self-help 
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programs are used. To overcome this problem, participants in the study will receive a weekly 
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reminder and motivational messages to access the online material. A positive relationship between 
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each respondent and their referral therapist will be also supported, and while on the one hand, the 
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professional remains available in case of need, the subject takes responsibility over the course of the 
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treatment. The learning process is emphasized, so to help the person improve self-management skills 
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and strategies to deal with their emotional problems.  
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Furthermore, the online format brings with it the advantage of allowing us to also support the 
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population of Italians abroad, of which the literature does not report any in-depth analysis. 
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RinascMENTE, therefore, represents the first attempt to provide online psychological support to the 
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segment of the Italian population abroad. 
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CONCLUSION 
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Since the beginning of the COVID-19 pandemic, studies demonstrated a significant clinical and 
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statistically decrease in mental health across populations worldwide. This burden is expected to 
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continue in the aftermath making high demand for timely and pragmatic psychological interventions 
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tailored to the unique and immediate needs of the general public. Preventive measures, fear of being 
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infected, and financial losses give a reason for the implementation and use of digital self-help 
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programs based on CBT principles and techniques – which might offer a range of self-management 
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strategies to cope with emotional difficulties, besides reducing the cost of the health care system (81).  
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DECLARATION 
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Ethics approval and consent to participate  
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The study protocol and informed consent to participate were approved by the Research Ethics 
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Committee of the Catholic University of Milan, Italy (25-21). All participants will sign in the online 
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informed consent to participate before entering the study. 
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Consent for publication 
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Participants will give their consent for the anonymous publication of their data by signing the online 
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informed consent form and information sheets  
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Availability of data and materials  
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All data will be identified only by a code, with personal details kept in a secure online platform with 
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access only by the immediate research team.  
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Competing interests 
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The authors declare that they have no competing interests. 
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Funding  
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The author(s) received no financial support for the research, authorship, and/or publication of this 
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article. 
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Authors’ contributions 
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Conceptualization, V.B, M.S., and G.P.; methodology, G.P., and G.A.; writing—original draft 
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preparation, V.B., and M.S.; writing—review and editing, G.P., G.A., GMM, and G.C.; visualization 
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and supervision, G.P. and G.A.; project administration, G.P., and E.M. All authors have read and 
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agreed to the published version of the manuscript. 
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Authors’ contributions 
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Not applicable 
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Trial status 
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Protocol Version 01 of February 2022 
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Start of recruitment: 21/02/2022 
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REFERENCES 
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