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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04632082
Other study ID # 20200213_Prevention
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 5, 2020
Est. completion date July 20, 2021

Study information

Verified date November 2020
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2200
Est. completion date July 20, 2021
Est. primary completion date July 13, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria (must present all of the following): Professionals and students from essential services suffering from low to moderate emotional distress - z score lower than 1.5 on the PROMIS Anxiety Scale - z score lower than 1.5 on the PROMIS Depression Scale - z score lower than 1.5 on the PROMIS Anger Scale Exclusion Criteria: - Moderate to severe suicide risk assessed by a psychiatrist

Study Design


Intervention

Behavioral:
Telepsychoeducation with personalized videos
1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
Telepsychoeducation without personalized videos
1 session with a psychologist focused on reassurance and aspects of the outbreak

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incident Cases in 6 months Proportion of participants with a T score equal or above 70 in any of three emotional distress subscales (Patient-Reported Outcomes Measurement Information System - or PROMIS - of Depression, Anxiety and Anger) 6-months
Secondary Incident cases Proportion of participants with a T score equal or above 60 in any of the emotional distress scales (PROMIS - of Depression, Anxiety and Anger) 1, 3 an 6-months
Secondary Service Satisfaction Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10) 2-weeks
Secondary Improvement in Quality of Life Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS) 1, 3 and 6-months
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