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

A Pragmatic Superiority Randomized Controlled Trial Comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the Reduction of Emotional Distress During COVID-19 Outbreak in Professionals and Students From Essential Services With a High Level of Emotional Distress in Brazil in the Context of COVID-19

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety; COVID; Emotional Distress; Mental Disorder; Irritable Mood
• Intervention / Treatment: Behavioral: Cognitive Behavioral Brief-Telepsychotherapy; Behavioral: Brief Interpersonal Telepsychotherapy; Behavioral: Telepsychoeducation

Detailed Description

PRAGMATIC TREATMENT TRIAL

TITLE: "A pragmatic superiority randomized controlled trial comparing Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation for the reduction of emotional distress during COVID-19 outbreak in professionals and students from essential services with a high level 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 interventions to reduce the burden caused by mental disorders during a pandemic outbreak of these proportions.

OBJECTIVE: To test the effectiveness of two modalities of Brief-Telepsychotherapy (Cognitive Behavioral and Interpersonal) to the reduction of symptoms of emotional distress (anxiety, depression, and irritability) in professionals and students from essential services with a high level of those symptoms in Brazil during the COVID-19 outbreak.

DESIGN, SETTING, AND PARTICIPANTS Thee-arm randomized clinical trial. Participants were recruited in Brazil from the national service of telehealth provided by the ministry of health. Participants included professional and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak. High levels of symptoms were defined by either of the following: (1) T score higher than 70 on the PROMIS Anxiety Scale; (2) T score higher than 70 on the PROMIS Depression Scale; (3) T score higher than 70 on the PROMIS Anger Scale.

INTERVENTIONS: All participants will be 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).

MAIN OUTCOMES AND MEASURES: The primary outcome will be the proportion of participants with a 50% reduction in T-scores in all the scales that were scored above 70 at baseline at 1-month. Secondary outcomes (1) the same measure of the primary outcome but measured at 3-month and 6-months follow-up; (2) mean score change in individual scales, quality of life and remission levels (proportion of patients with T-score of 50 or below in all of the four emotional distress subscales); (3) the same measure of the primary outcome but measured at midpoint (after the second session or 2-weeks); and (4) service satisfaction and net-promoter score at the end of the treatment.

EXPECTED RESULTS: To detect a 15% group difference between each group, an alpha of 0.017 (3 comparisons, 0,05/3), power of 90%, and 20% loss to follow up, we would need a total of 333 participants per group.

• Study Type: Interventional
• Enrollment (Anticipated): 999
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Moderate to severe suicide risk assessed by a psychiatrist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention I: Cognitive Behavioral Brief-Telepsychotherapy; 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; Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos
EXPERIMENTAL: Intervention II: Brief Interpersonal Telepsychotherapy; 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; Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos
ACTIVE_COMPARATOR: Active Comparator: Telepsychoeducation group; 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; A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Symptom Reduction at 3 and 6-months follow-up	Proportion of participants with a 50% reduction in T-scores at 3 and 6-months follow-up in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline measured	3 and 6-month
Remission Levels in distress scales	Remission levels (proportion of patients with T-score of 50 or below) in distress scales (PROMIS of Depression, Anxiety and Anger)	1, 3 and 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)	1-month

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre

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 18, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 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: Mental Disorders
• Other Study ID Numbers: 20200213_Treatment

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; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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