Distress, EmotionalNCT05782868
Expressive Writing Intervention Study
A study testing Expressive writing in response to vignette, Expressive writing about events of the day and Letter of Gratitude in people with Distress, Emotional, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress, Emotional
- What is being tested?
- Expressive writing in response to vignette, Expressive writing about events of the day and Letter of Gratitude
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cisgender individuals
- self-reported severe levels of psychological distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Well-Being Through Identity Affirmation and Social Connection in TNB Adults: An Expressive Writing Intervention
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.
Read the 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).
- Conditions
- Distress, Emotional
- Being tested
- Expressive writing in response to vignette, Expressive writing about events of the day, Letter of Gratitude
- Keywords
- transgender, nonbinary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writing in response to vignetteOther
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 dayOther
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 GratitudeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Expressive writing in response to vignette; Other: Letter of Gratitude |
| Control Condition | Experimental | Expressive writing assignment, without prompts. Receives: Other: Expressive writing about events of the day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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).
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One week post-baseline
Secondary outcomes (7)
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start8 Sep 2023
- Primary completion21 May 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distress, EmotionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elliot A Tebbe, PhD, LP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782868
- Sponsor's protocol ID
- 2022-1711
- Other IDs
- NUR/ACAD SVCS/ACAD SVCS, Protocol Version 11/28/2022
- Status last verified
- Sep 2024
- First submitted
- 2 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers may submit a written request to the PI to access de-identified data. The written request should include 1) a short background to describe rationale, 2) a description of the planned analysis, and 3) planned dissemination of findings. The PI reserves the right to approve or disapprove any request. Only de-identified survey data will be shared.
Publications
Tebbe E, Zepnick A, Brown R, Flentje A. Healing from within: A randomized controlled trial of a novel expressive writing intervention among trans and gender expansive adults. Am Psychol. 2026 Sep;81(6):986-1000. doi: 10.1037/amp0001639.
PubMed 42658633
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Well-Being Through Identity Affirmation and Social Connection in TNB Adults: An Expressive Writing Intervention
- ClinicalTrials.gov ID
- NCT05782868
- Acronym / sponsor ID
- 2022-1711
- Conditions
- Distress, Emotional
- Keywords
- transgender, nonbinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TNB Identity Affirmation (IA) Condition | Experimental | Other: Expressive writing in response to vignetteParticipants 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. |
| IA + Strengthening Social Connections (SSC) Condition | Experimental | Other: Expressive writing in response to vignette, Other: Letter of GratitudeFor 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. |
| Control Condition | Experimental | Other: Expressive writing about events of the dayExpressive writing assignment, without prompts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- cisgender individuals
- self-reported severe levels of psychological distress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writing in response to vignetteParticipants 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. | Other | IA + Strengthening Social Connections (SSC) Condition, TNB Identity Affirmation (IA) Condition |
| Expressive writing about events of the dayParticipants 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. | Other | Control Condition |
| Letter of GratitudeParticipants 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. | Other | IA + Strengthening Social Connections (SSC) Condition |
Primary outcome
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?
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).
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?
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.
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.
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.
7 secondary outcomes
Change in resilience as determined by scores on the Brief Resilience Scale (BRS)
Time frame: Baseline to 3 months
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
Change in psychological well-being
Time frame: Baseline to 3 months
Effects of expressive writing intervention on mental health
Time frame: Baseline to 3 months
Change in Gender Minority Stress and Resilience (GMSR)
Time frame: Baseline to 3 months
Change in satisfaction with life
Time frame: Baseline to 3 months
Change in perception of social support
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42658633Tebbe E, Zepnick A, Brown R, Flentje A. Healing from within: A randomized controlled trial of a novel expressive writing intervention among trans and gender expansive adults. Am Psychol. 2026 Sep;81(6):986-1000. doi: 10.1037/amp0001639.
- Individual participant dataSharing planned: Yes. Researchers may submit a written request to the PI to access de-identified data. The written request should include 1) a short background to describe rationale, 2) a description of the planned analysis, and 3) planned dissemination of findings. The PI reserves the right to approve or disapprove any request. Only de-identified survey data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot A Tebbe, PhD, LP principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in response to vignette, Expressive writing about events of the day and Letter of Gratitude in people with Distress, Emotional, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility of expressive writing intervention through qualitative data (time frame: One week post-baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.