Depressive Symptoms Clinical Trial
Official 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 From Essential Services With Low to Moderate Levels of Emotional Distress in Brazil in the Context of COVID-19
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. Note: This study was approved by the Ethics and Research Committee of the Hospital de Clínicas de Porto Alegre and is originally registered at Plataforma Brasil, a Brazilian study registration platform (under CAAE: 30608420.5.0000.5327). Recruitment began in May 28th 2020.
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. ;
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