Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19

NCT04635618 | Unknown

• 1 other identifier: 20200213_Treatment
• Study Type: interventional
• Target: 999
• Locations: 1 country
• Sites: 1

Brief Summary

The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control. 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 Disorder; COVID; Emotional Distress; Depression; Anxiety; Irritable Mood

Outcome Measures

Primary Outcomes (1)

• Symptom Reduction at 1-month

  Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.

  1-month

Secondary Outcomes (4)

• Symptom Reduction at 3 and 6-months follow-up

  3 and 6-month

• Remission Levels in distress scales

  1, 3 and 6-months

• Service Satisfaction

  1-month

• Improvement in Quality of Life

  1, 3 and 6-months

Study Arms (3)

Intervention I: Cognitive Behavioral Brief-Telepsychotherapy

EXPERIMENTAL

Four sessions of cognitive-behavioral therapy (CBT) conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content and content related to CBT technique.

Behavioral: Cognitive Behavioral Brief-Telepsychotherapy

Intervention II: Brief Interpersonal Telepsychotherapy

EXPERIMENTAL

Four sessions of interpersonal therapy (IPT) conducted by video call by a psychologist, accompanied by the sending of 2 to 3 minute videos with psychoeducational content and content related to the ITP technique.

Behavioral: Brief Interpersonal Telepsychotherapy

Active Comparator: Telepsychoeducation group

ACTIVE COMPARATOR

One single session of psychoeducation conducted through a video call by a psychologist, accompanied by sending videos of 2 to 3 minutes with psychoeducational content for 4 weeks.

Behavioral: Telepsychoeducation

Interventions

Cognitive Behavioral Brief-Telepsychotherapy BEHAVIORAL

Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos

Intervention I: Cognitive Behavioral Brief-Telepsychotherapy

Brief Interpersonal Telepsychotherapy BEHAVIORAL

Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos

Intervention II: Brief Interpersonal Telepsychotherapy

Telepsychoeducation BEHAVIORAL

A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks

Active Comparator: Telepsychoeducation group

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 high levels of emotional distress
• T score higher than 70 on the PROMIS Anxiety Scale
• T score higher than 70 on the PROMIS Depression Scale
• T score higher than 70 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, 90035-903, Brazil

Location

Related Publications (2)

• 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

• Martins DS, Viduani A, Dreher CB, Salum G, Manfro GG. Examining therapeutic alliance, adherence, and dropout in brief telepsychotherapy: A qualitative study. J Couns Psychol. 2025 Nov;72(6):699-709. doi: 10.1037/cou0000806. Epub 2025 Jun 2.

  PMID: 40455512 DERIVED

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Three-arm randomized clinical trial , including professionals and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak randomized 1:1:1: to the Cognitive Behavioral Brief-Telepsychotherapy group (B-CBT, four sessions), Brief Interpersonal Telepsychotherapy (B-IPT, four sessions) or Telepsychoeducation group (a single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks).

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 19, 2020
• Study Start: November 5, 2020
• Primary Completion: July 13, 2021
• Study Completion: July 20, 2021
• Last Updated: November 19, 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)