DepressionESCREVA-SENCT05349877
Efficacy of a Brief Intervention to Improve Sexual and Gender Minorities' Mental Health: Randomized Controlled Trial.
A study testing Expressive writing and Self-affirmation in people with Depression and Anxiety, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health… Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Psychological Distress
- What is being tested?
- Expressive writing and Self-affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2022to 19 Sep 2026
- 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 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Self-identity as sexual and gender minority.
- Being older than 16 years old.
- Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed.
- Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms.
- Currently living in Rio Grande do Sul.
Who cannot join
- Disagrees with the consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619-900
About this study
Official title: Efficacy of a Brief, Self-guided, On-line, Writing Intervention to Improve Mental Health Outcomes Among Sexual and Gender Minorities: a Randomized Controlled Trial.
Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health or illness. Sexual and gender minorities (SGM) face stigma and discrimination aggravating multiple aspects of their lives: from school drop-out to halting health care access. SGM reveal avoiding medical assistance for fear of discrimination while health professionals disclose feeling unprepared to handle SGM health needs. There are two main challenges: 1) developing specific psychological interventions to reduce the impact of stigma and discrimination on SGM' mental health; and 2) training public health professionals to properly address SGM needs. Therefore, the present trial aims to assess the efficacy of a brief, self-guided, on-line, asynchronous and unsupervised psychological intervention in improving SGM' mental health.
- Conditions
- Depression, Anxiety, Psychological Distress, Social Phobia, Post Traumatic Stress Disorder, Suicidal Ideation
- Being tested
- Expressive writing, Self-affirmation, Placebo
- Medical subject headings
- Depression, Anxiety Disorders, Phobia, Social, Stress Disorders, Post-Traumatic, Suicidal Ideation, Unsafe Sex, Social Discrimination, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
Write, continuously for 20 minutes, about deepest emotions and thoughts concerning experiences of minority stress, exploring a particular event and how it has affected the participant.
Self-affirmationBehavioural
Write, continuously for 20 minutes, about values the participant think is important to overcome experiences of minority stress.
PlaceboBehavioural
Write, continuously for 20 minutes, about their daily routine, without expressing feelings and deep thoughts about it.
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing | Experimental | Participants will be invited to join three writing activities, lasting 20 minutes daily in D1, D3, and D5 of the same week. For example, to write about a difficult or painful experience related discrimination and their feelings about it. Receives: Behavioral: Expressive writing |
| Self-affirmation | Experimental | Aiming to build self-efficacy, participants will be invite to writing, during 20 minutes daily in D1, D3, and D5 of the same week, a letter to a sexual and gender minority peer suffering from stigma and discrimination. Receives: Behavioral: Self-affirmation |
| Placebo | Placebo comparator | Participants will be instruct to write about their daily routine, during 20 minutes daily in D1, D3, and D5 of the same week. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline depression at 3 and 6 moths after the intervention.
Assessed using the Center for Epidemiologic Studies - Depression (CES-D). CES-D is composed of 20 items. The final score ranges from 0 to 60 points. Originally, the cutoff point of the CES-D scale to identify the presence of depressive symptoms is equal or higher 16 points. However, when considering Brazilian samples, the cutoff point of equal or higher 12 points was proposed.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline anxiety at 1 week, and 3 and 6 moths after the intervention.
Evaluated using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 questions based in part on the DSM-IV criteria for GAD and reflects the frequency of symptoms during the preceding 2-week period. The GAD-7 requires approximately 1-2 minutes to administer and for each symptom queried provides the following response options: "not at all," "several days," "over half the days" and "nearly every day" and these are scored, respectively, as 0, 1, 2 or 3. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline social phobia at 1 week, and 3 and 6 moths after the intervention.
Evaluated using the Social Avoidance and Distress Scale (SADS). SADS is a 28 item true/false scale that measures measures aspects of social anxiety including distress, discomfort, fear and avoidance. A total score on the SADS is obtained based on the answers to the true/false questions. Higher scores indicate greater social anxiety.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline post-traumatic stress at 1 week, and 3 and 6 moths after the intervention.
Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C). The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The score consists in adding up all items from each of the 17 items for a total severity score (range = 17-85). The cut off 17-29 shows little to no severity, 28-29 suggests some PTSD symptom, 30-44 moderate to moderately high severity of PTSD symptoms, and 45-85 high severity of PTSD symptoms.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline on suicide ideation at 3 and 6 moths after the intervention.
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a clinically-validated screening tool that healthcare providers use to screen for depression, and also to diagnose and monitor the severity of the condition. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Measured: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Change from baseline on substance use at 3 and 6 moths after the intervention.
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8 questions tool that detects substance use and related problems. A 'global continuum of risk score' (or total substance involvement) is calculated by the addition of all items for all substances on the ASSIST and has a maximum score of 208.
Measured: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Change from baseline on sex risk behaviors at 3 and 6 moths after the intervention.
Inquired using yes-no questions concerning unprotected intercourse and multiple sex partners, as well as the Perceived Risk of HIV Scale. Perceived Risk of HIV Scale is a self-report 8-item measure developed to assess how people think and feel about their risk of HIV infection based on their previous sexual behavior and covering several dimensions of perceived HIV risk. Higher scores are associated with a greater number of sex partners, episodes of unprotected sex and having sex while high.
Measured: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Secondary outcomes (2)
Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
Wagnild and Youngs's Resilience Scale that has presented the following scoring for the total score: 25-100 = Very low, 101-115 = Low, 116-130 = On the low end, 131-145 = Moderate, 146-160 = Moderately high, and 161-175 = High.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline on self-esteem at 1 week, and 3 and 6 moths after the intervention.
Rosenberg Self-Esteem Scale. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start15 Aug 2022
- Primary completion30 Dec 2022
- Study completion19 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Randomized, double-blind, clinical trial assessing the efficacy of a brief, unsupervised, self-guided psychological intervention targeting sexual and gender minorities' mental health.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349877
- Sponsor's protocol ID
- PUCRSBR-10098
- Other IDs
- 39059120.0.0000.5336
- Acronym
- ESCREVA-SE
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Brief, Self-guided, On-line, Writing Intervention to Improve Mental Health Outcomes Among Sexual and Gender Minorities: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05349877
- Acronym / sponsor ID
- ESCREVA-SE / PUCRSBR-10098
- Conditions
- Depression, Anxiety, Psychological Distress, Social Phobia, Post Traumatic Stress Disorder, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 19 Sep 2026 (actual)
- First posted
- 27 Apr 2022 (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.
Experiences of violence, from micro to physical aggressions, have a deleterious impact on mental health. According to the Minority Stress Theory, unfavorable social conditions (such as anticipated and experienced discrimination and internalized homophobia), mediated by resilience strategies, can lead to mental health or illness. Sexual and gender minorities (SGM) face stigma and discrimination aggravating multiple aspects of their lives: from school drop-out to halting health care access. SGM reveal avoiding medical assistance for fear of discrimination while health professionals disclose feeling unprepared to handle SGM health needs. There are two main challenges: 1) developing specific psychological interventions to reduce the impact of stigma and discrimination on SGM' mental health; and 2) training public health professionals to properly address SGM needs. Therefore, the present trial aims to assess the efficacy of a brief, self-guided, on-line, asynchronous and unsupervised psychological intervention in improving SGM' mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, clinical trial assessing the efficacy of a brief, unsupervised, self-guided psychological intervention targeting sexual and gender minorities' mental health.
| Arm | Type | Receives |
|---|---|---|
| Expressive writing | Experimental | Behavioral: Expressive writingParticipants will be invited to join three writing activities, lasting 20 minutes daily in D1, D3, and D5 of the same week. For example, to write about a difficult or painful experience related discrimination and their feelings about it. |
| Self-affirmation | Experimental | Behavioral: Self-affirmationAiming to build self-efficacy, participants will be invite to writing, during 20 minutes daily in D1, D3, and D5 of the same week, a letter to a sexual and gender minority peer suffering from stigma and discrimination. |
| Placebo | Placebo comparator | Behavioral: PlaceboParticipants will be instruct to write about their daily routine, during 20 minutes daily in D1, D3, and D5 of the same week. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identity as sexual and gender minority.
- Being older than 16 years old.
- Have a stable on-line connection for, at least, 20 minutes in a place where won't be disturbed.
- Reports, in the baseline survey, previous experiences of discrimination, having depression or anxiety symptoms.
- Currently living in Rio Grande do Sul.
Key exclusion criteria (1 listed)
- Disagrees with the consent form.
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 |
|---|---|---|
| Expressive writingWrite, continuously for 20 minutes, about deepest emotions and thoughts concerning experiences of minority stress, exploring a particular event and how it has affected the participant. | Behavioural | Expressive writing |
| Self-affirmationWrite, continuously for 20 minutes, about values the participant think is important to overcome experiences of minority stress. | Behavioural | Self-affirmation |
| PlaceboWrite, continuously for 20 minutes, about their daily routine, without expressing feelings and deep thoughts about it. | Behavioural | Placebo |
Primary outcome
Change from baseline depression at 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Assessed using the Center for Epidemiologic Studies - Depression (CES-D). CES-D is composed of 20 items. The final score ranges from 0 to 60 points. Originally, the cutoff point of the CES-D scale to identify the presence of depressive symptoms is equal or higher 16 points. However, when considering Brazilian samples, the cutoff point of equal or higher 12 points was proposed.
Change from baseline anxiety at 1 week, and 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Evaluated using the Generalized Anxiety Disorder 7-item (GAD-7). The GAD-7 consists of 7 questions based in part on the DSM-IV criteria for GAD and reflects the frequency of symptoms during the preceding 2-week period. The GAD-7 requires approximately 1-2 minutes to administer and for each symptom queried provides the following response options: "not at all," "several days," "over half the days" and "nearly every day" and these are scored, respectively, as 0, 1, 2 or 3. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases of GAD.
Change from baseline social phobia at 1 week, and 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Evaluated using the Social Avoidance and Distress Scale (SADS). SADS is a 28 item true/false scale that measures measures aspects of social anxiety including distress, discomfort, fear and avoidance. A total score on the SADS is obtained based on the answers to the true/false questions. Higher scores indicate greater social anxiety.
Change from baseline post-traumatic stress at 1 week, and 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C). The PCL-C is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The score consists in adding up all items from each of the 17 items for a total severity score (range = 17-85). The cut off 17-29 shows little to no severity, 28-29 suggests some PTSD symptom, 30-44 moderate to moderately high severity of PTSD symptoms, and 45-85 high severity of PTSD symptoms.
Change from baseline on suicide ideation at 3 and 6 moths after the intervention.
Time frame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a clinically-validated screening tool that healthcare providers use to screen for depression, and also to diagnose and monitor the severity of the condition. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression.
Change from baseline on substance use at 3 and 6 moths after the intervention.
Time frame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8 questions tool that detects substance use and related problems. A 'global continuum of risk score' (or total substance involvement) is calculated by the addition of all items for all substances on the ASSIST and has a maximum score of 208.
Change from baseline on sex risk behaviors at 3 and 6 moths after the intervention.
Time frame: Baseline (T0), three months after the intervention (T2), and six the intervention (T3).
Inquired using yes-no questions concerning unprotected intercourse and multiple sex partners, as well as the Perceived Risk of HIV Scale. Perceived Risk of HIV Scale is a self-report 8-item measure developed to assess how people think and feel about their risk of HIV infection based on their previous sexual behavior and covering several dimensions of perceived HIV risk. Higher scores are associated with a greater number of sex partners, episodes of unprotected sex and having sex while high.
2 secondary outcomes
Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Change from baseline on self-esteem at 1 week, and 3 and 6 moths after the intervention.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing and Self-affirmation in people with Depression and Anxiety, run by Pontificia Universidade Católica do Rio Grande do Sul 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 5 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: finished, as of the sponsor's last update on 24 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline depression at 3 and 6 moths after the intervention. (time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.