Expressive Writing Intervention Study

Distress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05782868
• Other study ID #: 2022-1711
• Secondary ID: NUR/ACAD SVCS/AC
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: August 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional

Intervention

Other:
• Expressive writing in response to vignette
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
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
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasibility of expressive writing intervention through qualitative data	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?	One week post-baseline
Primary	Assess the feasibility of expressive writing intervention by recording the number of attended writing sessions for each participant.	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).	One week post-baseline
Primary	Assess the acceptability of expressive writing intervention through qualitative data	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?	One week post-baseline
Primary	Effect of missed sessions on Positive and Negative Affect Scale (PANAS)	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.	One week post-baseline
Primary	Assess the fidelity of expressive writing intervention	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.	One week post-baseline
Primary	Amount of time spent writing	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.	One week post-baseline
Secondary	Change in resilience as determined by scores on the Brief Resilience Scale (BRS)	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.	Baseline to 3 months
Secondary	Change in state of depression, anxiety, and stress as determined by their scores on the Depression, Anxiety, and Stress Scale	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.	Baseline to 3 months
Secondary	Change in psychological well-being	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.	Baseline to 3 months
Secondary	Effects of expressive writing intervention on mental health	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.	Baseline to 3 months
Secondary	Change in Gender Minority Stress and Resilience (GMSR)	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.	Baseline to 3 months
Secondary	Change in satisfaction with life	Participants will indicate agreement with 5 items on a 1 to 7 scale, with higher scores indicating greater satisfaction with life.	Baseline to 3 months
Secondary	Change in perception of social support	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.	Baseline to 3 months