Clinical trial NCT04635618: Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19
Official 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 in the Context of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder
COVID
Emotional Distress
Depression
Anxiety
Irritable Mood
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom Reduction at 1-month
timeFrame: 1-month
Secondary outcomes:
measure: Symptom Reduction at 3 and 6-months follow-up
timeFrame: 3 and 6-month
measure: Remission Levels in distress scales
timeFrame: 1, 3 and 6-months
measure: Service Satisfaction
timeFrame: 1-month
measure: Improvement in Quality of Life
timeFrame: 1, 3 and 6-months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
name: Giovanni Salum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: