Clinical trial NCT05782868: Expressive Writing Intervention Study
Official title: Promoting Well-Being Through Identity Affirmation and Social Connection in TNB Adults: An Expressive Writing Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress, Emotional
Keywords: transgender
nonbinary
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Assess the feasibility of expressive writing intervention through qualitative data
timeFrame: One week post-baseline
measure: Assess the feasibility of expressive writing intervention by recording the number of attended writing sessions for each participant.
timeFrame: One week post-baseline
measure: Assess the acceptability of expressive writing intervention through qualitative data
timeFrame: One week post-baseline
measure: Effect of missed sessions on Positive and Negative Affect Scale (PANAS)
timeFrame: One week post-baseline
measure: Assess the fidelity of expressive writing intervention
timeFrame: One week post-baseline
measure: Amount of time spent writing
timeFrame: One week post-baseline
Secondary outcomes:
measure: Change in resilience as determined by scores on the Brief Resilience Scale (BRS)
timeFrame: Baseline to 3 months
measure: Change in state of depression, anxiety, and stress as determined by their scores on the Depression, Anxiety, and Stress Scale
timeFrame: Baseline to 3 months
measure: Change in psychological well-being
timeFrame: Baseline to 3 months
measure: Effects of expressive writing intervention on mental health
timeFrame: Baseline to 3 months
measure: Change in Gender Minority Stress and Resilience (GMSR)
timeFrame: Baseline to 3 months
measure: Change in satisfaction with life
timeFrame: Baseline to 3 months
measure: Change in perception of social support
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Elliot A Tebbe, PhD, LP
role: PRINCIPAL_INVESTIGATOR
References: