Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19
NCT ID: NCT04632082
Last Updated: 2020-11-20
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
2200 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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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 preventive interventions to reduce the burden caused by mental disorders after the occurrence of a pandemic outbreak in these proportions.
OBJECTIVE: To compare the effectiveness of Telepsychoeducation with personalized videos to Telepsychoeducaton without personalized videos for the prevention of severe symptoms of emotional distress (anxiety, depression and irritability) in health professionals with a low to moderate level of those symptoms in Brazil during the COVID-19 outbreak.
DESIGN, SETTING, AND PARTICIPANTS Two-group randomized clinical trial. Participants were recruited in Brazil from the national service of telehealth provided by the ministry of health. Participants included health professionals suffering from low to moderate levels of anxiety, depression and irritability symptoms during the COVID-19 outbreak. Low to moderate levels of symptoms were defined by all of the following: (1) z score lower than 1.5 on the PROMIS Anxiety Scale; (2) z score lower than 1.5 on the PROMIS Depression Scale; (3) z score lower than 1.5 on the PROMIS Anger Scale.
INTERVENTIONS: All participants were randomized to the Telepsychoeducation with personalized videos (1 session with a psychologist plus 1 videos a week for 4 weeks, chosen based on symptom presentation) or Telepsychoeducation without personalized videos (1 session with a psychologist focused on reassurance and aspects of the outbreak).
MAIN OUTCOMES AND MEASURES: The primary outcome will be the proportion of participants with a T score equal or above 70 in any of the emotional distress scales (anxiety, depression or irritability) in 6 months. Secondary outcomes (1) mean score change in individual scales at 1, 3 and 6 months; (2) proportion of participants with a T score equal or above 60 in any of the emotional distress scales at 1, 3 and 6 months; and (3) service satisfaction and net-promoter score at the end of the treatment.
EXPECTED RESULTS: To detect a 5% group difference between each group, an alpha of 0.05, power of 90% and 20% loss to follow up, in a 1:1 randomization, we would need a total of 1100 participants per group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention: Telepsychoeducation with personalized videos
One psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology. The intervention is complemented by the sending of 4 videos of 2 to 3 minutes, with psychoeducational content, sent each week by the therapist.
Telepsychoeducation with personalized videos
1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
Comparator: Telepsychoeducation without personalized videos
One psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology.
Telepsychoeducation without personalized videos
1 session with a psychologist focused on reassurance and aspects of the outbreak
Interventions
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Telepsychoeducation with personalized videos
1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
Telepsychoeducation without personalized videos
1 session with a psychologist focused on reassurance and aspects of the outbreak
Eligibility Criteria
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Inclusion Criteria
* z score lower than 1.5 on the PROMIS Anxiety Scale
* z score lower than 1.5 on the PROMIS Depression Scale
* z score lower than 1.5 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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Salum GA, Spanemberg L, Costa MA, Simioni AR, Gosmann NP, Hartmann de Souza L, Cuijpers P, Pine DS, Brunoni AR, Katz N, Umpierre RN, Kristensen CH, Manfro GG, Fleck MP, Dreher CB. Single-session intervention with and without video support to prevent the worsening of emotional distress among healthcare workers during the SARS-CoV-2 pandemic: a randomised clinical trial. BMJ Ment Health. 2025 Apr 7;28(1):e301416. doi: 10.1136/bmjment-2024-301416.
Costa MA, Kristensen CH, Dreher CB, Manfro GG, Salum GA. Habituating to pandemic anxiety: Temporal trends of COVID-19 anxiety over sixteen months of COVID-19. J Affect Disord. 2022 Sep 15;313:32-35. doi: 10.1016/j.jad.2022.06.077. Epub 2022 Jun 27.
Other Identifiers
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20200213_Prevention
Identifier Type: -
Identifier Source: org_study_id