Effectiveness of self-help plus (SH+) in reducing anxiety and post-traumatic symptomatology among care home workers during the COVID-19 pandemic: a randomized controlled trial

Abstract

This article describes a randomized controlled trial to evaluate the effectiveness of a supervised online delivery of self-help plus (SH+), during the second wave of COVID-19 contagions in Northern Italy. The SH+ is a psychological intervention developed by the World Health Organization to increase a person's ability to deal with stress. In this trial, it was tested primarily as a tool to reduce anxiety and post-traumatic symptomatology in workers of residential nursing and care homes. In order to partial out non-specific effects of the intervention, the SH+ was compared to an equally supervised and structured alternative activity. Secondarily, in view of future emergencies, the potential of SH+ as a tool to reduce perceived stress, increase subjective well-being and foster individual resilience was explored. At post-intervention, the preregistered analysis revealed no difference in self-reported anxiety and/or post-traumatic symptomatology between the group receiving the SH+ and the group engaged in an alternative activity. Some specific and positive effects of the SH+ intervention were only found on self-reported intervention effectiveness and engagement in exploratory analyses. These findings raise the question whether the previously documented effectiveness of the SH+ on self-reported symptomatology and on the prevention of psychiatric conditions could be attributed mostly to non-specific rather than specific factors connected with participant enrolment in a psychological intervention. Indeed, the effects of the SH+ had been previously compared only to the effects of not being engaged in any alternative activity (often described in the literature as 'treatment as usual'-or 'enhanced treatment as usual', when some relevant information is given to the control group as a one-off). Given the negative findings of this study, before the SH+ is implemented in clinical practice, further studies should be conducted to examine its short- and long-term beneficial effects, by means of randomized studies that employ alternative but similarly structured interventions as control conditions, aiming to minimize the confounding effect of non-specific factors.

Keywords: PTSD; anxiety; care homes; nursing homes; randomized controlled trial; self-help plus.

Figure 1.

RCT flow diagram. The red dotted rectangle signposts the primary outcome data lock. The trial took 20, instead of the expected 18, weeks due to a two-week delay in the start of post-test 2. This delay was necessary to maintain parallel testing across NCH during the holiday season (see footnote 2).

Figure 2.

CONSORT flow diagram showing the number of participants included in the randomization and analyses, and the number of dropouts per intervention at follow-ups.

Figure 3.

The figure shows the percentage of at least mild symptoms of anxiety and/or post-traumatic stress, separately for the two arms of the RCT, across time (baseline, post-intervention follow-up and 14-week follow-up). The figure shows data from randomized participants who logged in at least once.