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

• ClinicalTrials.gov Identifier: NCT04632082
• Recruitment Status: Enrolling by invitation
• First Posted: November 17, 2020
• Last Update Posted: November 20, 2020
• Sponsor: Hospital de Clinicas de Porto Alegre
• Information provided by (Responsible Party): Giovanni Abrahao Salum Junior, Hospital de Clinicas de Porto Alegre

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mental Health Wellness 1; COVID; Emotional Distress; Depressive Symptoms; Anxiety Symptoms; Irritability; Telepsychotherapy	Behavioral: Telepsychoeducation with personalized videos; Behavioral: Telepsychoeducation without personalized videos	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-group randomized clinical trial including health professionals and health students suffering from low to moderate levels of anxiety, depression and irritability symptoms during the COVID-19 outbreak, randomized randomized 1:1 to the Telepsychoeducation with personalized videos (2 sessions with a psychologist plus 2 videos a week for 4 weeks chosen based on symptom presentation) or Telepsychoeducation without personalized videos (2 sessions with a psychologist focused on reassurane and aspects of the outbreak).
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: November 5, 2020
• Estimated Primary Completion Date: July 13, 2021
• Estimated Study Completion Date: July 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incident Cases in 6 months [ Time Frame: 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)

Secondary Outcome Measures :

1. Incident cases [ Time Frame: 1, 3 an 6-months ]
   Proportion of participants with a T score equal or above 60 in any of the emotional distress scales (PROMIS - of Depression, Anxiety and Anger)
2. Service Satisfaction [ Time Frame: 2-weeks ]
   Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)
3. Improvement in Quality of Life [ Time Frame: 1, 3 and 6-months ]
   Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande Do Sul, Brazil

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Giovanni Salum, MD, PhD; Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil

More Information

• Responsible Party: Giovanni Abrahao Salum Junior, Principal Investigator, Hospital de Clinicas de Porto Alegre
• ClinicalTrials.gov Identifier: NCT04632082
• Other Study ID Numbers: 20200213_Prevention
• First Posted: November 17, 2020
• Last Update Posted: November 20, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Behavioral Symptoms