Mental DisorderNCT04635618
Psychotherapy Strategies for the Treatment of Professionals and Students From Essential Services With High Levels of Emotional Distress in the Context of COVID-19
A study testing Cognitive Behavioral Brief-Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation in people with Mental Disorder and COVID, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Disorder, COVID, Emotional Distress
- What is being tested?
- Cognitive Behavioral Brief-Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 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 high levels of emotional distress
- 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
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, 90035-903
About this study
Official 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 in the Context of COVID-19
The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control.
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
PRAGMATIC TREATMENT TRIAL
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
- Mental Disorder, COVID, Emotional Distress, Depression, Anxiety, Irritable Mood
- Being tested
- Cognitive Behavioral Brief-Telepsychotherapy, Brief Interpersonal Telepsychotherapy, Telepsychoeducation
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Brief-TelepsychotherapyBehavioural
Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos
Brief Interpersonal TelepsychotherapyBehavioural
Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos
TelepsychoeducationBehavioural
A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention I: Cognitive Behavioral Brief-Telepsychotherapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Brief-Telepsychotherapy |
| Intervention II: Brief Interpersonal Telepsychotherapy | Experimental | 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. Receives: Behavioral: Brief Interpersonal Telepsychotherapy |
| Active Comparator: Telepsychoeducation group | Active comparator | 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. Receives: Behavioral: Telepsychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Reduction at 1-month
Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.
Measured: 1-month
Secondary outcomes (4)
Symptom Reduction at 3 and 6-months follow-up
Proportion of participants with a 50% reduction in T-scores at 3 and 6-months follow-up in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline measured
Measured: 3 and 6-month
Remission Levels in distress scales
Remission levels (proportion of patients with T-score of 50 or below) in distress scales (PROMIS of Depression, Anxiety and Anger)
Measured: 1, 3 and 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: 1-month
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 posted19 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 (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm randomized clinical trial , including professionals and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak 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).
- Masking
- None (open label)
- Enrolment
- 999 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
- NCT04635618
- Sponsor's protocol ID
- 20200213_Treatment
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 19 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 41499179Martins 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 Nov;72(6):699-709. doi: 10.1037/cou0000806. Epub 2025 Jun 2.
PubMed 40455512
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 in the Context of COVID-19
- ClinicalTrials.gov ID
- NCT04635618
- Acronym / sponsor ID
- 20200213_Treatment
- Conditions
- Mental Disorder, COVID, Emotional Distress, Depression, Anxiety, Irritable Mood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 999 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
- 19 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.
The study consists in a pragmatic superiority randomized controlled trial comparing different strategies of psychotherapy for professionals and students from essential services with high levels of emotional distress during the COVID-19 pandemic in Brazil. Therapeutic strategies to be evaluated are Brief Cognitive Behavioral Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation, as an active control.
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
PRAGMATIC TREATMENT TRIAL
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm randomized clinical trial , including professionals and students from essential services suffering from high levels of anxiety, depression, and irritability symptoms during the COVID-19 outbreak 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention I: Cognitive Behavioral Brief-Telepsychotherapy | Experimental | Behavioral: Cognitive Behavioral Brief-TelepsychotherapyFour 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. |
| Intervention II: Brief Interpersonal Telepsychotherapy | Experimental | Behavioral: Brief Interpersonal TelepsychotherapyFour 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. |
| Active Comparator: Telepsychoeducation group | Active comparator | Behavioral: TelepsychoeducationOne 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. |
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 high levels of emotional distress
- 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
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 |
|---|---|---|
| Cognitive Behavioral Brief-TelepsychotherapyFour sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos | Behavioural | Intervention I: Cognitive Behavioral Brief-Telepsychotherapy |
| Brief Interpersonal TelepsychotherapyFour sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos | Behavioural | Intervention II: Brief Interpersonal Telepsychotherapy |
| TelepsychoeducationA single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks | Behavioural | Active Comparator: Telepsychoeducation group |
Primary outcome
Symptom Reduction at 1-month
Time frame: 1-month
Proportion of participants with a 50% reduction in T-scores at 1-month in the scales Patient-Reported Outcomes Measurement Information System (PROMIS) of Depression, Anxiety and Anger that were scored above 70 at baseline.
4 secondary outcomes
Symptom Reduction at 3 and 6-months follow-up
Time frame: 3 and 6-month
Remission Levels in distress scales
Time frame: 1, 3 and 6-months
Service Satisfaction
Time frame: 1-month
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 19 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 40455512Martins 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 Nov;72(6):699-709. doi: 10.1037/cou0000806. Epub 2025 Jun 2.
- 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 Cognitive Behavioral Brief-Telepsychotherapy, Brief Interpersonal Telepsychotherapy and Telepsychoeducation in people with Mental Disorder 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 19 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?
Symptom Reduction at 1-month (time frame: 1-month). 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 NCT04635618, which also lists 2 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 19 Nov 2020.