Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services 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 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.

Study Overview

• Status: Unknown
• Conditions: Depressive Symptoms; COVID; Irritability; Mental Health Wellness 1; Anxiety Symptoms; Emotional Distress; Telepsychotherapy
• Intervention / Treatment: Behavioral: Telepsychoeducation with personalized videos; Behavioral: Telepsychoeducation without personalized videos

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 2200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Telepsychoeducation with personalized videos; One psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology. The intervention is complemented by the sending of 4 videos of 2 to 3 minutes, with psychoeducational content, sent each week by the therapist.	Behavioral: Telepsychoeducation with personalized videos; 1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
Active Comparator: Comparator: Telepsychoeducation without personalized videos; One psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology.	Behavioral: Telepsychoeducation without personalized videos; 1 session with a psychologist focused on reassurance and aspects of the outbreak

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

Publications and helpful links

General Publications

• Costa MA, Kristensen CH, Dreher CB, Manfro GG, Salum GA. Habituating to pandemic anxiety: Temporal trends of COVID-19 anxiety over sixteen months of COVID-19. J Affect Disord. 2022 Sep 15;313:32-35. doi: 10.1016/j.jad.2022.06.077. Epub 2022 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): July 13, 2021
• Study Completion (Anticipated): July 20, 2021

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 15, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20200213_Prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Plan to share study protocol, SAP, ICF, CRS, analytic code and individual-based variables.
• IPD Sharing Time Frame: Avaliable six months after study completion (antecipated - January 2022)
• IPD Sharing Access Criteria: Researchers and civil society
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No