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A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels of emotional distress in Brazil.
Note: This study was approved by the Ethics and Research Committee of the Hospital de ClÃnicas 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.
TITLE: "A pragmatic superiority randomized controlled trial comparing Telepsychoeducation plus personalized videos vs. Telepsychoeducation without personalized videos for the prevention of future emotional distress in professionals and students from essential services with low to moderate levels 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Telepsychoeducation with personalized videos | Experimental | 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. |
|
| Comparator: Telepsychoeducation without personalized videos | Active Comparator | One psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telepsychoeducation with personalized videos | Behavioral | 1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident Cases in 6 months | Proportion of participants with a T score equal or above 70 in any of three emotional distress subscales (Patient-Reported Outcomes Measurement Information System - or PROMIS - of Depression, Anxiety and Anger) | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Incident cases | Proportion of participants with a T score equal or above 60 in any of the emotional distress scales (PROMIS - of Depression, Anxiety and Anger) | 1, 3 an 6-months |
| Service Satisfaction |
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Inclusion Criteria (must present all of the following):
Professionals and students from essential services suffering from low to moderate emotional distress
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Salum, MD, PhD | Hospital de ClÃnicas de Porto Alegre, Porto Alegre/Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41499179 | Derived | Damiano RF, Abreu M, Dreher CB, Bryan CJ, Miguel EC, Fleck M, Manfro GG, Salum GA. Risk Factors for Suicide Attempts and Psychiatric Hospitalization Among Brazilian Health Care Professionals. J Clin Psychiatry. 2025 Dec 31;87(1):25m15858. doi: 10.4088/JCP.25m15858. | |
| 40194849 | Derived | 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. |
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Plan to share study protocol, SAP, ICF, CRS, analytic code and individual-based variables.
Avaliable six months after study completion (antecipated - January 2022)
Researchers and civil society
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Two-group randomized clinical trial including health professionals and health students suffering from low to moderate levels of anxiety, depression and irritability symptoms during the COVID-19 outbreak, randomized randomized 1:1 to the Telepsychoeducation with personalized videos (2 sessions with a psychologist plus 2 videos a week for 4 weeks chosen based on symptom presentation) or Telepsychoeducation without personalized videos (2 sessions with a psychologist focused on reassurane and aspects of the outbreak).
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| Telepsychoeducation without personalized videos | Behavioral | 1 session with a psychologist focused on reassurance and aspects of the outbreak |
|
Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)
| 2-weeks |
| 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 |
| 35772625 | Derived | 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. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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