Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19
NCT ID: NCT04635618
Last Updated: 2020-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
999 participants
INTERVENTIONAL
2020-11-05
2021-07-20
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Cognitive Behavioral Brief-Telepsychotherapy
Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos
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.
Brief Interpersonal Telepsychotherapy
Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos
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.
Telepsychoeducation
A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks
Interventions
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Cognitive Behavioral Brief-Telepsychotherapy
Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos
Brief Interpersonal Telepsychotherapy
Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos
Telepsychoeducation
A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Giovanni Abrahao Salum Junior
Principal Investigator
Principal Investigators
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Giovanni Salum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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References
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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 Jun 2. doi: 10.1037/cou0000806. Online ahead of print.
Other Identifiers
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20200213_Treatment
Identifier Type: -
Identifier Source: org_study_id