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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04632082
• Other study ID #: 20200213_Prevention
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety Symptoms
• COVID
• Depression
• Depressive Symptoms
• Emotional Distress
• Irritability
• Mental Health Wellness 1
• Telepsychotherapy

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