Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19
Study Details
Study Description
Brief Summary
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Telepsychoeducation with personalized videos
1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
|
| Active Comparator: 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. |
Behavioral: Telepsychoeducation without personalized videos
1 session with a psychologist focused on reassurance and aspects of the outbreak
|
Outcome Measures
Primary Outcome Measures
- Incident Cases in 6 months [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)
Secondary Outcome Measures
- Incident cases [1, 3 an 6-months]
Proportion of participants with a T score equal or above 60 in any of the emotional distress scales (PROMIS - of Depression, Anxiety and Anger)
- Service Satisfaction [2-weeks]
Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)
- Improvement in Quality of Life [1, 3 and 6-months]
Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)
Eligibility Criteria
Criteria
Inclusion Criteria (must present all of the following):
Professionals and students from essential services suffering from low to moderate emotional distress
-
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:
- Moderate to severe suicide risk assessed by a psychiatrist
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil |
Sponsors and Collaborators
- Hospital de Clinicas de Porto Alegre
Investigators
- Principal Investigator: Giovanni Salum, MD, PhD, Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20200213_Prevention