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短期干预改善性和性别少数群体心理健康的功效:随机对照试验。 (ESCREVA-SE)

简短、自导、在线、书面干预改善性和性别少数群体心理健康结果的功效:一项随机对照试验。

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.

研究概览

研究类型

介入性

注册 (实际的)

306

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90619-900
        • Pontifícia Universidade Católica do Rio Grande do Sul

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 100年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Disagrees with the consent form.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Expressive writing

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.

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.

实验性的:Self-affirmation

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.

Write, continuously for 20 minutes, about values the participant think is important to overcome experiences of minority stress.

安慰剂比较:Placebo

Participants will be instruct to write about their daily routine, during 20 minutes daily in D1, D3, and D5 of the same week.

Write, continuously for 20 minutes, about their daily routine, without expressing feelings and deep thoughts about it.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from baseline depression at 3 and 6 moths after the intervention.
大体时间: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.

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.
大体时间: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.

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.
大体时间: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.

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.
大体时间: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.

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.
大体时间: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.

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.
大体时间: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.

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.
大体时间: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.

Baseline (T0), three months after the intervention (T2), and six the intervention (T3).

次要结果测量

结果测量
措施说明
大体时间
Change from baseline on resilience at 1 week, and 3 and 6 moths after the intervention.
大体时间: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.

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.
大体时间: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.

Baseline (T0), one week after the intervention (T1), three months after the intervention (T2), and six the intervention (T3).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年8月15日

初级完成 (实际的)

2022年12月30日

研究完成 (实际的)

2026年9月19日

研究注册日期

首次提交

2022年3月11日

首先提交符合 QC 标准的

2022年4月22日

首次发布 (实际的)

2022年4月27日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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