An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. Health systems are facing major challenges: In addition to the risks for physical health, the COVID-19 pandemic also represents a burden for mental health [1]. Pandemic-related stressors such as quarantine, social isolation/distancing, unemployment, financial losses, caregiver stress, and confrontation with illness and death can have a negative impact on mental health [1]. For example, in a study on the severe acute respiratory syndrome (SARS) pandemic, approximately 40% of the study population experienced increased stress related to work, finances and family and 16% showed signs of posttraumatic stress [2]. Preliminary research on the psychological impact of the COVID-19 pandemic indicates increased levels of psychological distress in the general population [3, 4]. Symptoms of anxiety, depression, and self-reported stress are suggested psychological reactions to the COVID-19 pandemic [5, 6].

Although pandemics comprise a multitude of stressors that may strain mental health, not everybody is experiencing psychological distress in response. Moreover, individuals might differ in the amount and kind of stressors they are exposed to, and therefore, some individuals might be at higher risk for mental health problems [7]. Some of the stressors that occur during a pandemic can be considered critical life events (e.g., death of loved ones and job loss) and require adjustment to changed life circumstances [8]. A lack of adjustment can lead to psychological distress, for example expressed in a change of one’s psychological condition. This can include experiencing depressive and anxiety symptoms [9]. Furthermore, maladaptive adjustment to critical life events might eventually lead to full-blown mental disorders like adjustment disorders (AjD) or depression [10‐12].

Some recommendations for interventions targeting psychological distress due to the COVID-19 pandemic have been made: Firstly, cognitive behavioral therapy (CBT), in particular the restructuring of thought patterns and cognitive thinking traps, as well as activity planning and relaxation techniques are considered suitable interventions [6, 13]. Secondly, digital aids such as internet-based self-help interventions are encouraged, as they do not require physical contact and are easily scalable [6, 14, 15].

The efficacy of internet-based self-help interventions for various psychological problems is established [16, 17]. However, internet-based interventions can differ in their design, especially in the degree of therapist support that they offer. While some internet-based interventions offer contact with a therapist (guided self-help) other interventions are completely automated (unguided self-help). Moreover, guided self-help interventions can differ in the intensity of provided contact. On the one hand, guided self-help programs yield higher effect-sizes and have higher retention rates than unguided self-help programs [18, 19]. On the other hand, unguided self-help programs have the advantage that they are less costly and better scalable [20]. One promising approach, possibly combining the benefits of both guided and unguided self-help programs, is the use of guidance on demand [21]. Guidance on demand implies that support from a therapist is only established when requested by a participant. An internet-based self-help program for increased self-criticism with guidance on demand showed promising results [22]. Nonetheless, an internet-based self-help program for symptoms of anxiety and/or depression based on problem-solving therapy with guidance on demand had the same effect as the unguided version of the same program [23]. Likewise, an internet-based self-help program for tinnitus-related distress based on CBT with guidance on demand did not differ in its effectiveness from the unguided version of that program [24].

To the best of our knowledge, there is no study that has evaluated an internet-based self-help intervention for psychological distress due to COVID-19 in the general population yet. However, an internet-based self-help intervention for patients diagnosed with COVID-19 experiencing psychological distress has been evaluated in a small randomized controlled trial (RCT) [25]. The internet-based self-help intervention consisted of audio-recorded instructions focusing on relaxation, self-care, and a rising sense of security, which were uploaded online. Over a 2-week period, participants in the intervention group listened to the instructions via their mobile phone and performed a daily task, which took about 50 min. The intervention addressed COVID-19 patients with mild-to-moderate depression and/or anxiety symptoms. The average age of the 26 participants was 44.7 years; 62% were male and 38% were female. Ninety-two percent of the participants experienced at least mild depression symptoms and 62% experienced at least mild anxiety symptoms. Participants in the intervention group showed a significant reduction in depression and anxiety symptoms compared to the control group [25] .

Against this background, we developed an internet-based self-help intervention with guidance on demand called ROCO. This intervention specifically addresses individuals experiencing psychological distress due to the COVID-19 pandemic. Hence, the study aims to evaluate the efficacy and feasibility of the internet-based self-help program ROCO for people with psychological distress due to the COVID-19 pandemic.

The specific objectives of the study are:

The study is a parallel group RCT comparing an internet-based self-help intervention combined with care as usual (CAU) to a waiting control condition with only CAU. The study flowchart is displayed in Fig. 1. Participants in the waiting control condition receive access to the intervention 3 weeks after the baseline questionnaire. Eligible participants are randomly allocated to one of the two conditions in a 1:1 allocation ratio.

The aim of the RCT is to show the superiority of the internet-based self-help intervention combined with CAU to only CAU at the 3-week post assessment. Additionally, there will be 2 follow-up measurements after 6, respectively 18 weeks after the baseline questionnaire. Since at the time of the follow-up measurements both groups have used the internet-based self-help intervention, the groups can no longer be compared. However, we use these follow-up measurements to assess the sustainability of potential treatment gains, i.e., to examine whether the short-term effects of the internet-based self-help intervention are maintained within groups. In addition, the follow-up measurements will be used to explore predictors of the sustainability of potential treatment effects.

The single study center is located at the University of Bern, Switzerland. All data is collected online using questionnaires programmed in Qualtrics [26]. Data is collected in German-speaking areas (i.e., Switzerland, Germany, Austria, and Liechtenstein).

All interested persons must provide full written informed consent and are required to complete a baseline-screening questionnaire prior to randomization to assess eligibility.

Inclusion criteria are:

Exclusion criteria are:

Not applicable as no ancillary studies are performed.

The efficacy of the intervention is to be established. This is why we have chosen a waiting control condition as comparator. However, both the participants in the waiting control condition as well as in the intervention condition receive CAU, whereby CAU can range from no treatment at all to psychotherapy and/or drug therapy. Participants in the waiting control condition receive access to the internet-based self-help program after a waiting period of 3 weeks. We decided to give participants in the waiting control condition access to the program after only 3 weeks since, due to the pressing situation surrounding the COVID-19 pandemic, we wanted to give all participants access to psychological support as fast as possible. However, this has the implication that only short-term effects of the intervention can be assessed.

The intervention is a 3-week internet-based self-help program with guidance on demand called ROCO. The self-help program consists of 6 thematic modules including texts, videos, graphics, exercises, and for each module a weekly task. The 6 thematic modules are supplemented by an introduction and a conclusion. For a detailed description, see Table 1. Furthermore, the self-help program comprises a page with information on what to do in an acute crisis, including a list with emergency contacts, as well as a page named Toolbox, where the weekly tasks are listed. Participants also can track their symptoms on a page named Mood-Tracker.

Participants are encouraged to work through two of the 6 thematic modules per week. One module takes between 40 to 80 min to complete. However, participants can determine the timing and order of the modules themselves. The first module includes information about possible psychological consequences and challenges concerning the situation surrounding COVID-19. In the second module, participants receive information concerning ways to deal with difficult feelings that may arise due to the current situation. The third module focuses on restructuring thought patterns and cognitive thinking traps and the fourth module on promoting resilience and coping skills. The fifth module consists of information about sleep hygiene and relaxation techniques. Finally, the last module addresses self-care and personal growth.

As the self-help program offers guidance on demand, participants have the possibility to contact a psychologist, but there is no scheduled contact per se. Participants can require guidance via chat function in the self-help program. They are informed that a psychologist will answer their request within 3 working days. Otherwise, the self-help program is unguided.

Since internet-based self-help is not suited as a treatment for acute suicidality, participants reporting an acute crisis during treatment are referred to an appropriate treatment. This will be recorded and reported as an adverse event.

Participants have the possibility to enable reminders within the self-help program. They can choose whether the reminder is sent via e-mail or text message after a certain time of inactivity. In the reminder, participants are encouraged to log into the self-help program again. We have further adopted a guidance on demand approach, since some form of support appears to increase adherence [19].

Participants receiving the intervention, as well as participants in the waiting control condition are allowed to start any concomitant treatment at any time during the trial. However, participants must indicate at each measurement time whether they use concomitant psychological or psychiatric treatment (e.g., psychotherapy or drug therapy).

The University of Bern will provide insurance for any harm suffered as a result from this trial.

All assessments are carried out online via self-observation questionnaires. The baseline measurement is at t₀, the post-measurement t₁ is at 3 weeks, the first follow-up measurement t₂ is at 6 weeks, and the second follow-up measurement t₃ is at 18 weeks after the baseline. Validated German versions of the questionnaires are used. For an overview of all outcome measures and corresponding measurement time points, see Fig. 2.

(Figure 2).

To specify the sample size needed for the different analyses, we conducted a power analysis based on a probability level of 0.05 and a power of 0.80 with G*Power [53] for a repeated-measures ANOVA with a within-between-interaction. To test the efficacy of the self-help program compared to the control condition, we expected a small-to-medium between group effect size of d = 0.35 and a correlation between the factors of at least r = 0.4. The expected effect size is based on the results of meta-analyses on the effectiveness of unguided internet-based self-help programs targeting depressive symptoms [17, 54]. We decided to base the expected effect size on unguided internet-based self-help programs as it is yet to be determined if a guidance on demand approach yields higher effect sizes than unguided self-help [23, 24] . Power analysis indicated a necessary sample size of 80 individuals. In consideration of a possible attrition rate between 5.4 and 45.5% at post-assessment, we aim to recruit between 80 and 120 participants at baseline [17].

Participants are recruited from the general population via the study web page. This study web page is advertised on various websites, internet forums and social media. The study web page includes information about the self-help program and the study. People interested in participating can leave their e-mail address on the study homepage and will then be sent the detailed participant information per e-mail.

Eligible participants will be randomly allocated to either the intervention or the waiting control condition with a 1:1 allocation ratio as per a computer generated randomization schedule using randomly permuted block sizes by Randomization.​com [55].

The allocation schedule was generated by an independent researcher and is unknown to the investigators. Allocation takes place after the baseline assessment has been completed. Since the allocated condition is not known until the interested individual has been recruited into the trial, allocation concealment is ensured.

All interested individuals who give written informed consent for participation and who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized. Staff members responsible for recruitment and data management will ask the independent researcher to randomize respective individuals. In return, the independent researcher informs the staff members per e-mail about the allocation. Finally, the staff members inform the individual about the assigned condition per e-mail.

The staff members are not blinded to the allocation. However, all assessments are performed online with self-report questionnaires. Since participants either receive direct access to the self-help program or have a waiting period, participants are neither blinded to their allocation.

Not applicable since no blinding is performed.

All data is assessed online by means of questionnaires programmed in Qualtrics [26]. In addition, data on the use of the self-help program (e.g., number of logins or processed pages) is collected within the self-help program.

The participants are asked by e-mail to complete the online questionnaires. If participants fail to complete a questionnaire, they will be reminded by e-mail to do so: for post measurement, they will be reminded after 5 and 10 days and for follow-up measurements after 7 and 14 days. All participants are asked to complete the online questionnaire at each point of measurement, regardless of protocol adherence or any previously uncompleted online questionnaires.

Data quality is ensured through several mechanisms, including referential data rules, valid values, range checks, and consistency checks. The option to choose a value from a list of valid codes and a description of the meaning of the code will be available where applicable. Checks are applied at the time of data entry into a specific field. All data collected is stored on a firewall-encrypted back-upped server of the University of Bern with strictly regulated access only for researchers directly involved in the study.

All data concerning participant information will be stored in locked file cabinets only accessible for staff members. All collected data will only be traceable by a code. All files containing names or other personal identifiers, such as the informed consent forms, will be stored separately from data containing this code number.

Not applicable since no biological specimens are used.

Moreover, we will exploratory analyze possible predictors, mediators, and moderators for the relationship between the internet-based self-help program and the outcomes. The significance level is set at 5%. Analyses will be conducted using SPSS and R.

Not applicable since no interim analyses are planned.

Not applicable since no additional analyses such as subgroup analyses are planned.

Statistical analyses will be carried out according to the intention-to-treat approach and therefore will include all randomized participants. The extent of missing data will be analyzed. We will explore missing data patterns and determine the type of missing data (missing completely at random, missing at random, not missing at random). We will use multiple imputation to substitute missing values and will conduct sensitivity analyses for both the datasets with and without the imputed data.

There are no plans for granting public access to the full protocol, participant-level dataset, and statistical code.

There is no trial steering committee. The composition of the coordinating center is as follows:

As to the best of our knowledge, the internet-based self-help program in itself does not bear risks for the participants. Therefore, a data monitoring committee is not required. The principal investigator, the co-principal investigator and the PhD students warrant for data and participant safety.

In this trial, adverse events are defined as unintended negative developments in the participants, which may occur at the time of the use of the internet-based self-help program, but do not have to be causally related to its use. Those unintended negative developments in the participants include acute suicidality and hospitalization. Such adverse events and the corresponding actions taken will be documented in the case report form.

The research management of the Faculty of Human Sciences at the University of Bern, an independent research control unit, warrants the auditing. There will be on site monitoring visits on a regular basis. The monitoring visits are documented in a monitoring report form. The data monitoring committee controls study procedures such as the site progress and enrollment, obtaining participant informed consent, randomization, or the reporting of adverse events.

Important protocol amendments will be reported to the relevant parties (i.e., the Cantonal Ethics committee Bern, the trial participants and trial registries) by e-mail. Substantial amendments are only implemented after approval of the Cantonal Ethics committee Bern. All non-substantial amendments are communicated to the Cantonal Ethics committee Bern within the Annual Safety Report.

Trial participants and the general population are informed about the results of the study by means of a results report.