Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19

TITLE: "A pragmatic superiority randomized controlled trial comparing Telepsychoeducation
plus personalized videos vs. Telepsychoeducation without personalized videos for the
prevention of future emotional distress in professionals and students from essential services
with low to moderate levels of emotional distress in Brazil"

IMPORTANCE: COVID-19 outbreak is associated with increased emotional distress (depression,
anxiety and irritability) all over the world. Currently, there are no large randomized trials
testing preventive interventions to reduce the burden caused by mental disorders after the
occurrence of a pandemic outbreak in these proportions.

OBJECTIVE: To compare the effectiveness of Telepsychoeducation with personalized videos to
Telepsychoeducaton without personalized videos for the prevention of severe symptoms of
emotional distress (anxiety, depression and irritability) in health professionals with a low
to moderate level of those symptoms in Brazil during the COVID-19 outbreak.

DESIGN, SETTING, AND PARTICIPANTS Two-group randomized clinical trial. Participants were
recruited in Brazil from the national service of telehealth provided by the ministry of
health. Participants included health professionals suffering from low to moderate levels of
anxiety, depression and irritability symptoms during the COVID-19 outbreak. Low to moderate
levels of symptoms were defined by all of the following: (1) z score lower than 1.5 on the
PROMIS Anxiety Scale; (2) z score lower than 1.5 on the PROMIS Depression Scale; (3) z score
lower than 1.5 on the PROMIS Anger Scale.

INTERVENTIONS: All participants were randomized to the Telepsychoeducation with personalized
videos (1 session with a psychologist plus 1 videos a week for 4 weeks, chosen based on
symptom presentation) or Telepsychoeducation without personalized videos (1 session with a
psychologist focused on reassurance and aspects of the outbreak).

MAIN OUTCOMES AND MEASURES: The primary outcome will be the proportion of participants with a
T score equal or above 70 in any of the emotional distress scales (anxiety, depression or
irritability) in 6 months. Secondary outcomes (1) mean score change in individual scales at
1, 3 and 6 months; (2) proportion of participants with a T score equal or above 60 in any of
the emotional distress scales at 1, 3 and 6 months; and (3) service satisfaction and
net-promoter score at the end of the treatment.

EXPECTED RESULTS: To detect a 5% group difference between each group, an alpha of 0.05, power
of 90% and 20% loss to follow up, in a 1:1 randomization, we would need a total of 1100
participants per group.