Expressive Writing Intervention Study

NCT05782868 | Completed

• 3 other identifiers: 2022-1711NUR/ACAD SVCS/ACAD SVCSProtocol Version 11/28/2022
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Distress, Emotional

Keywords

transgender; nonbinary

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

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

  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 psychological well-being

  Baseline to 3 months

• Effects of expressive writing intervention on mental health

  Baseline to 3 months

• Change in Gender Minority Stress and Resilience (GMSR)

  Baseline to 3 months

Study Arms (3)

TNB Identity Affirmation (IA) Condition

EXPERIMENTAL

Participants in the IA only intervention condition will receive the same prompt for all four days of writing, a design used in expressive writing interventions to allow for deeper and continued reflection into specific thoughts and emotions.

Other: Expressive writing in response to vignette

IA + Strengthening Social Connections (SSC) Condition

EXPERIMENTAL

For participants in the IA+SSC condition, participants will complete the IA intervention on the first three days. On the fourth day, participants will be directed to compose a brief letter.

Other: Expressive writing in response to vignette; Other: Letter of Gratitude

Control Condition

EXPERIMENTAL

Expressive writing assignment, without prompts.

Other: Expressive writing about events of the day

Interventions

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.

IA + Strengthening Social Connections (SSC) Condition; TNB Identity Affirmation (IA) Condition

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.

Control Condition

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.

IA + Strengthening Social Connections (SSC) Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Elliot A Tebbe, PhD, LP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 24, 2023
• Study Start: September 8, 2023
• Primary Completion: May 21, 2024
• Study Completion: June 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will be made available for a period of 5 years post data collection.
• Access Criteria: PhD prepared researcher, holds a current appointment in an institution of higher education.

Locations

US (1)