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临床试验/NCT05782868
NCT05782868进行中(未招募)不适用

Promoting Well-Being Through Identity Affirmation and Social Connection in TNB Adults: An Expressive Writing Intervention

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2023年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
117
试验地点
2
主要终点
Effect of missed sessions on Positive and Negative Affect Scale (PANAS)

研究概览

简要总结

This study aims to test to what extent an expressive writing intervention may reduce internalized anti-TNB (trans and nonbinary) stigma and promote well-being over time. Trans and/or nonbinary people may take part in this study, and can expect to participate for 3 months.

详细描述

This study aims to decrease internalized transnegativity and to promote positive and affirming thoughts and emotions related to being transgender/nonbinary through a novel four-day expressive writing intervention. Participants will be trans/nonbinary English-speaking adults (18+) who reside in the US. They will be randomized to one of three study conditions (control, affirming identity, affirming identity + strengthening social connection) and will be enrolled in the study for period of 3 months (baseline, four day intervention, Days 7, 30, and 90 follow up).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • transgender or nonbinary
  • access to a phone, computer, and/or device from which they can access the surveys and daily writing session tasks
  • ability to read and write English

排除标准

  • cisgender individuals
  • self-reported severe levels of psychological distress

结局指标

主要结局

Effect of missed sessions on Positive and Negative Affect Scale (PANAS)

时间窗: One week post-baseline

Participants' total scale scores to the Positive and Negative Affect Scale (PANAS), which can range from 10 to 50, with higher scores indicating greater positive affect (positive affect subscale) and lower scores indicating lower levels of negative affect (negative affect subscale), will be analyzed for their correlations with missed sessions and/or participant attrition, as documented through participant attendance scores, described above.

Assess the feasibility of expressive writing intervention through qualitative data

时间窗: One week post-baseline

Collect open-ended text responses to the following question: Considering the logistical and practical side of this study, what was your experience like completing the writing tasks this last week? For example, did you find it easy or challenging to write for the full 20 minutes each session? How was it writing using the device that you did, such as writing in Word and uploading to Qualtrics or writing directly in Qualtrics?

Assess the feasibility of expressive writing intervention by recording the number of attended writing sessions for each participant.

时间窗: One week post-baseline

Analyze any differences in number of attended writing sessions for participants by condition, with each participants' attendance score ranging from 0 (none) to 4 (all).

Assess the fidelity of expressive writing intervention

时间窗: One week post-baseline

Analyze participants' writing to assess the degree to which intervention condition writing instructions were followed. Two members of the research team will assess participants' writing and code for the presence of emotion/affect-related words (yes=1, no=0), focus on gender identity (yes=1, no=0), and advice or encouragement offered (yes=1, no=0). Interrater agreement will be assessed.

Assess the acceptability of expressive writing intervention through qualitative data

时间窗: One week post-baseline

Collect open-ended text responses to the following question: Emotionally, what was your experience like completing the writing sessions this last week? Did you notice any changes in your emotional experience over the course of the week?

Amount of time spent writing

时间窗: One week post-baseline

To assess fidelity of intervention, participants will be asked to self-report how much time they spent writing each day. Qualtrics data will also be examined to assess how many minutes participants spent in the survey.

次要结局

  • Change in resilience as determined by scores on the Brief Resilience Scale (BRS)(Baseline to 3 months)
  • Change in psychological well-being(Baseline to 3 months)
  • Change in state of depression, anxiety, and stress as determined by their scores on the Depression, Anxiety, and Stress Scale(Baseline to 3 months)
  • Change in perception of social support(Baseline to 3 months)
  • Change in Gender Minority Stress and Resilience (GMSR)(Baseline to 3 months)
  • Change in satisfaction with life(Baseline to 3 months)
  • Effects of expressive writing intervention on mental health(Baseline to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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