Pilot Feasibility Study of Remote Problem Management Plus for Adults Affected by COVID-19

Problem Management Plus (PM+) is recommended as part of the World Health Organization Mental
Health Gap Action Program for communities affected by adversity. It is a low-intensity,
scalable manualized intervention that was designed according to a task-sharing model of care.
PM+ has four core features that make the intervention suitable for populations exposed to
adversities in low-resource settings. First, it is a brief intervention (five sessions);
second, it can be delivered by paraprofessionals (trained, non-specialist workers, lay or
peer providers under the supervision of a mental health professional), using the principle of
task shifting/task sharing; third, it is designed as a trans-diagnostic intervention to
address a range of client-identified emotional (e.g. depression, anxiety, traumatic stress,
general stress) and practical problems; and, fourth, it is designed for communities affected
by any kind of adversity (e.g. violence, disasters) in low-income countries. The intervention
was originally developed for adults affected by humanitarian crises and tested in low-income
countries. A number of randomized controlled trials in Kenya, Pakistan, Nepal, as well as the
Netherlands have indicated that PM+ delivered by non-specialist helpers is effective in
decreasing symptoms of psychological distress (including depression, anxiety and
post-traumatic stress disorder symptoms) and improving functioning; however, empirical
evidence of the feasibility and efficacy of the remote training and delivery of PM+ is
limited.

In May 2020, the United Nations released a policy brief emphasizing inclusion of mental
health and psychosocial support (MHPSS) in national response plans including scaling up
access to remote support (UN, 2020). The brief was released in response to emerging concerns
of the negative mental health and psychosocial impacts arising from the health and societal
consequences of COVID-19. Extant population-based research is showing high rates of anxiety,
depression, and general distress in the US, while at the same time MHPSS provision has been
disrupted or halted due to social distancing measures. Remote delivery forms of PM+ may serve
as an important mechanism to facilitate access to care during the ongoing pandemic and into
the future. Furthermore, there is very limited research with PM+ in high-income countries
where specialized mental health interventions are available, but where access for certain
populations or during periods of public health crisis is limited due to systemic and
practical barriers. Even in high income countries, only 22.4% of those with depression
receive minimally adequate care; however, 64.9% of those with depression perceive a need for
treatment. The treatment gap may be considerably higher among marginalized groups and
economically disadvantaged communities. COVID-19 continues to bring on widespread mental
health disparities, particularly among vulnerable and underserved communities that are
disproportionately affected by COVID-19. Brief, low-intensity interventions designed to be
implemented by non-specialists represent a promising and scalable approach to minimize this
treatment gap in under-served US populations by partnering with community-based organizations
(CBO) to train and supervise staff already involved in social and public health services. An
important first step before investing resources in training and implementation with CBOs is
to evaluate the feasibility, acceptability and effectiveness of remotely delivered PM+ with
relevant community samples.

This is the first study to evaluate remotely delivered PM+ implemented by helpers whose
training and supervision was conducted entirely online, as well as one of the first trials
evaluating PM+ with community samples in the US. The aims of this pilot feasibility study are
to a) assess interest from perspective beneficiaries by partnering with community-based
organizations in New York City to recruit participants; b) to gather and evaluate information
about the feasibility, acceptability and safety of the intervention, in particular when
implemented via remote delivery; c) to identify whether the clinical and content adaptations
that were made during the remote training, adaptation and conduct of initial practice cases
are appropriate for the setting; and d) to assess possible problems of recruitment, delivery
of the intervention and retention to ensure that procedures are adequate for a cluster
randomized control trial. Additionally, the investigators will employ a single-arm,
uncontrolled design in order to begin to examine the effectiveness and impact of remotely
delivered PM+ among community members in New York City who are experiencing symptoms of
common mental health problems. Lastly, trainees' knowledge and perceived self-efficacy in a)
foundational helping skills based on common therapeutic factors and b) intervention-specific
competencies will be evaluated pre-training, post-training and post-supervision.