Mental Health Wellness 1NCT04632082
Telepsychoeducation for the Prevention of Emotional Distress in Professionals and Students From Essential Services in the Context of COVID-19
A study testing Telepsychoeducation with personalized videos and Telepsychoeducation without personalized videos in people with Mental Health Wellness 1 and COVID, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health Wellness 1, COVID, Emotional Distress
- What is being tested?
- Telepsychoeducation with personalized videos and Telepsychoeducation without personalized videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2020to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe suicide risk assessed by a psychiatrist
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official 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 From Essential Services With Low to Moderate Levels of Emotional Distress in Brazil in the Context of COVID-19
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.
Read the 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.
- Conditions
- Mental Health Wellness 1, COVID, Emotional Distress, Depressive Symptoms, Anxiety Symptoms, Irritability
- Being tested
- Telepsychoeducation with personalized videos, Telepsychoeducation without personalized videos
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepsychoeducation with personalized videosBehavioural
1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
Telepsychoeducation without personalized videosBehavioural
1 session with a psychologist focused on reassurance and aspects of the outbreak
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telepsychoeducation with personalized videos |
| 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. Receives: Behavioral: Telepsychoeducation without personalized videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6-months
Secondary outcomes (3)
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)
Measured: 1, 3 an 6-months
Service Satisfaction
Service satisfaction measured by the net-promoter score at the end of the treatment (proportion of promoters - scores of 9 or 10)
Measured: 2-weeks
Improvement in Quality of Life
Mean score change in quality of life scale (PROMIS General Life Satisfaction Scale or GLSS)
Measured: 1, 3 and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start5 Nov 2020
- Primary completion13 Jul 2021 (estimated)
- Study completion20 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Abrahao Salum Junior, Hospital de Clinicas de Porto Alegre
- Investigators
- Giovanni Salum, MD, PhD, Principal investigator, Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632082
- Sponsor's protocol ID
- 20200213_Prevention
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share study protocol, SAP, ICF, CRS, analytic code and individual-based variables.
Publications
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.
PubMed 41499179Salum 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.
PubMed 40194849Costa 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.
PubMed 35772625
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 From Essential Services With Low to Moderate Levels of Emotional Distress in Brazil in the Context of COVID-19
- ClinicalTrials.gov ID
- NCT04632082
- Acronym / sponsor ID
- 20200213_Prevention
- Conditions
- Mental Health Wellness 1, COVID, Emotional Distress, Depressive Symptoms, Anxiety Symptoms, Irritability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 13 Jul 2021 (estimated)
- Study completion
- 20 Jul 2021 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention: Telepsychoeducation with personalized videos | Experimental | Behavioral: Telepsychoeducation with personalized videosOne 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 | Behavioral: Telepsychoeducation without personalized videosOne psychoeducation session administered by a therapist by video call, with interventions focused on promoting protective factors and reducing common risk factors for psychopathology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Moderate to severe suicide risk assessed by a psychiatrist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telepsychoeducation with personalized videos1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation | Behavioural | Intervention: Telepsychoeducation with personalized videos |
| Telepsychoeducation without personalized videos1 session with a psychologist focused on reassurance and aspects of the outbreak | Behavioural | Comparator: Telepsychoeducation without personalized videos |
Primary outcome
Incident Cases in 6 months
Time frame: 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)
3 secondary outcomes
Incident cases
Time frame: 1, 3 an 6-months
Service Satisfaction
Time frame: 2-weeks
Improvement in Quality of Life
Time frame: 1, 3 and 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 41499179Damiano 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.
- Derived from this study: PubMed 40194849Salum 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.
- Derived from this study: PubMed 35772625Costa 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.
- Individual participant dataSharing planned: Yes. Plan to share study protocol, SAP, ICF, CRS, analytic code and individual-based variables.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Salum, MD, PhD principal investigator
Hospital de Clínicas de Porto Alegre, Porto Alegre/Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepsychoeducation with personalized videos and Telepsychoeducation without personalized videos in people with Mental Health Wellness 1 and COVID, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Cases in 6 months (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.