Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619-900, Brazil
NCT Number: NCT05349877
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.
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Notify Me16 year–100 year
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90619-900, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Write, continuously for 20 minutes, about values the participant think is important to overcome experiences of minority stress.
Write, continuously for 20 minutes, about their daily routine, without expressing feelings and deep thoughts about it.
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
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.
Time frame: Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).
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.
Pontificia Universidade Católica do Rio Grande do Sul
Other
Efficacy of a Brief, Self-guided, On-line, Writing Intervention to Improve Mental Health Outcomes Among Sexual and Gender Minorities: a Randomized Controlled Trial.
Acronym: ESCREVA-SE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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