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

NCT04632082 | Unknown

• 1 other identifier: 20200213_Prevention
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incident cases

  1, 3 an 6-months

• Service Satisfaction

  2-weeks

• Improvement in Quality of Life

  1, 3 and 6-months

Study Arms (2)

Intervention: Telepsychoeducation with personalized videos

EXPERIMENTAL

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

Comparator: Telepsychoeducation without personalized videos

ACTIVE COMPARATOR

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

Interventions

Telepsychoeducation with personalized videos BEHAVIORAL

1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation

Intervention: Telepsychoeducation with personalized videos

Telepsychoeducation without personalized videos BEHAVIORAL

1 session with a psychologist focused on reassurance and aspects of the outbreak

Comparator: Telepsychoeducation without personalized videos

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Moderate to severe suicide risk assessed by a psychiatrist

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (3)

• Damiano RF, Abreu M, Dreher CB, Bryan CJ, Miguel EC, Fleck M, Manfro GG, Salum GA. Risk Factors for Suicide Attempts and Psychiatric Hospitalization Among Brazilian Health Care Professionals. J Clin Psychiatry. 2025 Dec 31;87(1):25m15858. doi: 10.4088/JCP.25m15858.

  PMID: 41499179 DERIVED

• Salum GA, Spanemberg L, Costa MA, Simioni AR, Gosmann NP, Hartmann de Souza L, Cuijpers P, Pine DS, Brunoni AR, Katz N, Umpierre RN, Kristensen CH, Manfro GG, Fleck MP, Dreher CB. Single-session intervention with and without video support to prevent the worsening of emotional distress among healthcare workers during the SARS-CoV-2 pandemic: a randomised clinical trial. BMJ Ment Health. 2025 Apr 7;28(1):e301416. doi: 10.1136/bmjment-2024-301416.

  PMID: 40194849 DERIVED

• 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.

  PMID: 35772625 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Giovanni Salum, MD, PhD

  Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 17, 2020
• Study Start: November 5, 2020
• Primary Completion: July 13, 2021
• Study Completion: July 20, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Avaliable six months after study completion (antecipated - January 2022)
• Access Criteria: Researchers and civil society

Locations

BR (1)