Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04635618 |
| Other study ID # |
20200213_Treatment |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 5, 2020 |
| Est. completion date |
July 20, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
Hospital de Clinicas de Porto Alegre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
