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Completed

NCT Number: NCT05782868

Expressive Writing Intervention Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Expressive writing in response to vignette

Other

Participants will read a vignette, which describes the experience and response of a young adult who experiences rejection from a close friend after a first disclosure of their gender identity. Participants will then be asked to write in response to three prompts: 1) identify expressions of internalized transphobia in the vignette character, 2) reflect on times the participant has experienced similar feelings, 3) identify thoughts and feelings that promote and support a positive and affirming identity in contrast to negative emotions and thoughts.

Expressive writing about events of the day

Other

Participants in the control condition will be asked to write about the events of their day and thoughts and feelings that occurred in response to those events.

Letter of Gratitude

Other

Participants will be directed to compose a brief letter of gratitude to an individual to whom they have not previously expressed gratitude, and who has provided meaningful and affirming support to them as a TNB person.

Primary outcomes

  1. Assess the feasibility of expressive writing intervention through qualitative data

    Time frame: 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?

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

    Time frame: 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).

  3. Assess the acceptability of expressive writing intervention through qualitative data

    Time frame: 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?

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

    Time frame: 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.

  5. Assess the fidelity of expressive writing intervention

    Time frame: 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.

  6. Amount of time spent writing

    Time frame: 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.

Secondary outcomes

  1. Change in resilience as determined by scores on the Brief Resilience Scale (BRS)

    Time frame: Baseline to 3 months

    Using the Brief Resilience Scale, participants will indicate the extent to which they agree with several statements on a scale of 1 to 5, where 1 = strongly disagree and 5 = strongly agree. A higher score indicates lower resilience.

  2. Change in state of depression, anxiety, and stress as determined by their scores on the Depression, Anxiety, and Stress Scale

    Time frame: Baseline to 3 months

    Using the Depression Anxiety Stress Scale (DASS), participants will indicate their negative emotional states of depression, anxiety and stress on a 0-3 scale, with higher scores indicating greater degree of depression, anxiety, or stress.

  3. Change in psychological well-being

    Time frame: Baseline to 3 months

    Using the Psychological Well-Being Scale (PWB), participants will indicate their level of well-being on an 18 item scale, with a range of 1 to 7, where higher scores indicate greater levels of psychological well-being.

  4. Effects of expressive writing intervention on mental health

    Time frame: Baseline to 3 months

    Neuro-QoL short form: Two subscales with 7 (general concerns) and 8 items (fatigue), respectively. Rated on a 1-5 scale, with higher scores indicating lower levels of quality of life in each domain.

  5. Change in Gender Minority Stress and Resilience (GMSR)

    Time frame: Baseline to 3 months

    GMSR: Three subscales with 8 (Pride), 8 (Internalized transphobia), and 5 (community connectedness) items respectively. Rated on a 1-5 scale with higher scores indicating higher levels of pride, internalized transphobia, and community connectedness.

  6. Change in satisfaction with life

    Time frame: Baseline to 3 months

    Participants will indicate agreement with 5 items on a 1 to 7 scale, with higher scores indicating greater satisfaction with life.

  7. Change in perception of social support

    Time frame: Baseline to 3 months

    Using TNB Social Support, participants will report number of contacts, as well as degree of closeness with each contact on a scale of 1 to 7, with higher scores indicating greater perception of social support.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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