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Depressive SymptomsEWMSNCT05897021

Expressive Writing on Minority Stressors Among Sexual Minority Veterans

A study testing Expressive Writing on Minority Stressors and Neutral Writing in people with Depressive Symptoms and Anxiety, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sexual minority stressors (e.g., sexual minority identity-based discrimination) contribute to greater risk for and severity of depression, anxiety, substance use disorders and suicide among sexual minority Veterans. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Symptoms, Anxiety
What is being tested?
Expressive Writing on Minority Stressors and Neutral Writing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
1 siteUnited States
Study dates
20 Mar 2024to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants will be Veterans who:
  • identify as a sexual minority (i.e., identify as gay, lesbian, bisexual, pansexual, queer, or another identity other than heterosexual)
  • endorse clinically significant depressive or anxiety symptoms (score above 10 on the PHQ-9 or GAD-7)
  • report a history of sexuality-based minority stressor exposure that is contributing to distress on phone screening
  • be stable on psychotropic medication for at least 4 weeks if on a psychotropic medication

Who cannot join

  • The exclusion criteria for Veterans in this study are:
  • clear and current suicidal plan and/or intent (assessed via the Columbia Suicide Severity Rating Scale)
  • current presentation of unstable mania and/or psychosis (assessed via the Structured Interview for DSM-5)
  • current substance use disorder, severe (assessed via the Structured Interview for DSM-5)
  • significant cognitive impairment, including evidence of moderate or severe traumatic brain injury, determined by an inability to comprehend baseline screening questionnaires

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kelly L Harper, PhD contact

(857) 364-4417

kelly.harper@va.gov

Brian P Marx, PhD contact

(857) 364-6071

brian.marx@va.gov

United States1 site, 1 recruiting
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Kelly L Harper, PhD, 857-364-4417, kelly.harper@va.gov

    Brian P Marx, PhD, (857) 364-6071, brian.marx@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Expressive Writing to Reduce Depressive and Anxiety Symptoms Among Sexual Minority Veterans

Sexual minority stressors (e.g., sexual minority identity-based discrimination) contribute to greater risk for and severity of depression, anxiety, substance use disorders and suicide among sexual minority Veterans. However, no brief, scalable, one-on-one interventions targeting sexual minority stressor-related distress are available in Veterans Affairs (VA) for sexual minority Veterans. The proposed research will examine the feasibility, acceptability, and preliminary effectiveness of a brief, 3-session expressive writing intervention to target distress related to sexual minority stressor exposure among sexual minority Veterans. The results of this work will advance knowledge about a promising brief and easy to implement intervention focused on reducing depressive and anxiety symptoms among sexual minority Veterans. This proposal aligns with VA's and CSR\&D's commitment to providing equitable services to sexual minority Veterans and the aim of reducing health disparities among underserved Veteran groups.

Read the detailed description

Sexual minority Veterans (e.g., gay, lesbian, bisexual) are one of the highest risk populations for psychiatric disorders due in part to the experience of discrimination and stigma-based stressors (sexual minority stressors). These stressors and the associated stress responses contribute to greater severity of depression and anxiety, which confer risk for negative health outcomes (hazardous substance use and suicide). However, very few interventions target distress related to sexual minority stressors, and even fewer have been tested in Veteran Health Administration (VHA). Brief, easy to implement interventions that target distress related to sexual minority stressors are needed to address the unique mental health concerns of this high risk community of Veterans. Expressive writing is a brief, well-developed paradigm that involves writing about thoughts and emotions related to a stressful experience for at least 15 minutes, 3-5 times based on a structured writing prompt. Over 30 years of research supports expressive writing's effectiveness in reducing stress, depression, and anxiety related to a stressor. Expressive writing on a minority stressor (EWMS) has been shown to reduce depression and anxiety among sexual minority non-Veterans but has never been tested among sexual minority Veterans. The aim of the proposed study is to examine the feasibility, acceptability, and preliminary effectiveness of EWMS, a promising intervention for sexual minority Veterans. Based on consultation with experts in expressive writing and sexual minority Veteran health, EWMS will be adapted for sexual minority Veterans and a VHA clinic setting. EWMS will be implemented as a 3 session, one-on-one intervention with a therapist. The proposed EWMS protocol will be iteratively refined in a case series (n = 10), and then tested in a pilot randomized control trial (RCT; n = 54) comparing EWMS to a neutral writing control condition. Aims of the pilot RCT are: 1) demonstrate feasibility and acceptability of study procedures and EWMS using quantitative and qualitative data; and 2) examine the preliminary effectiveness of EWMS relative to control in reducing depressive and anxiety symptom severity. The proposed research aims are in direct alignment with the applicant's short term and long term training goals. The proposed research and complimentary mentorship and training plans will enable the applicant to: 1) gain expertise in intervention adaptation and clinical trial research; 2) gain expertise in sexual minority health; 3) develop aptitude in implementation theory and processes to inform future implementation of the proposed intervention and other interventions; and 4) achieve career independence. The results of the pilot RCT along with the training and mentorship of this project will inform a Merit award submission comparing EWMS with an active control in a hybrid I implementation-effectiveness trial to test the efficacy of the intervention while collecting information on barriers and facilitators to implementation of the intervention. This proposed research, training, and mentorship plan will provide the applicant with the necessary skills and experience to transition into an independent clinical researcher in VA focused on the development, enhancement, and implementation of interventions for minority related stress among sexual minority Veterans. The research and training will take place at the National Center for Posttraumatic Stress Disorder at the VA Boston Healthcare System under the supportive, collaborative, and accomplished mentorship team, including Drs. Brian Marx (primary mentor), Katherine Iverson (co-mentor), and Nicholas Livingston (co-mentor). These mentors have unique, yet complimentary, areas of expertise and have an established and successful history working together and with the applicant. The research, mentorship, and training proposed will facilitate the applicant's transition into a successful and productive independent VA investigator conducting research that directly aligns with VA's priority to provide equitable, patient-centered services to Veterans.

Being tested
Expressive Writing on Minority Stressors, Neutral Writing
Keywords
Sexual Minorities, Veterans, Depressive Symptoms, Anxiety
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive Writing on Minority StressorsBehavioural

    The EWMS protocol will consist of 3 sessions delivered by a therapist (either in-person or remotely via telehealth platform) to sexual minority Veterans. The intervention will begin with an overview of the intervention, brief psychoeducation about expressive writing, and a review of the potential benefits of expressive writing. The initial session will also consist of psychoeducation on sexual minority stressors and common reactions to these stressors (i.e., universal stress reactions and minority-identity specific reactions) and how this relates to psychological outcomes, such as depression and anxiety, and high-risk behaviors, such as substance use and suicidal ideation. The initial session will be 60 minutes (introduction, psychoeducation, and first writing exercise) and the following two sessions (feedback, writing exercises, and check-ins) will take approximately 40 minutes.

  • Neutral WritingBehavioural

    To be comparable to EWMS, the control intervention will also be a 3-session individual intervention involving engaging in a writing exercise per session. For the control writing exercises, participants will be asked to write for 30 minutes about their daily activities since waking up that day based on Pennebaker's standard writing paradigm (Pennebaker \& Beall, 1987). Individuals in the control condition will also be given information about the purpose of the writing exercises to be comparable to the psychoeducation information provided in EWMS. Similar to EWMS, the clinician will check in with the participant about the writing session, such as asking how the session went and how it felt to do the writing, following the 30 minutes of writing.

Study groups in NCT05897021
Study groupRoleWhat they receive
Expressive Writing on Minority StressorsExperimentalThe EWMS protocol will consist of 3 sessions delivered by a therapist (either in-person or remotely via telehealth platform) to sexual minority Veterans. The intervention will begin with an overview of the intervention, brief psychoeducation about expressive writing, and a review of the potential benefits of expressive writing. The initial session will also consist of psychoeducation on sexual minority stressors and common reactions to these stressors (i.e., universal stress reactions and minority-identity specific reactions) and how this relates to psychological outcomes, such as depression and anxiety, and high-risk behaviors, such as substance use and suicidal ideation. The initial session will be 60 minutes (introduction, psychoeducation, and first writing exercise) and the following two sessions (feedback, writing exercises, and check-ins) will take approximately 40 minutes.
Receives: Behavioral: Expressive Writing on Minority Stressors
Neutral WritingPlacebo comparatorTo be comparable to EWMS, the control intervention will also be a 3-session individual intervention involving engaging in a writing exercise per session. For the control writing exercises, participants will be asked to write for 30 minutes about their daily activities since waking up that day based on Pennebaker's standard writing paradigm (Pennebaker \& Beall, 1987). Individuals in the control condition will also be given information about the purpose of the writing exercises to be comparable to the psychoeducation information provided in EWMS. Similar to EWMS, the clinician will check in with the participant about the writing session, such as asking how the session went and how it felt to do the writing, following the 30 minutes of writing.
Receives: Behavioral: Neutral Writing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the Expressive Writing on Minority Stressors (EWMS) intervention

    Level of feasibility will be assessed by comparable percentage of treatment completion as found in a previous efficacy trial of Expressive Writing on Minority Stressors in a non-Veteran sample (Pachankis et al., 2021). The percentage of treatment completion will be comparable to percentage of treatment completion reported in a previous efficacy trial of EWMS with young adults (89%) (Pachankis et al., 2021).

    Measured: This will be assessed through study completion at the end of Phase II of the Study (i.e., end of the 4th year)

  2. Patient satisfaction with the Expressive Writing on Minority Stressors (EWMS) intervention

    Veterans who are assigned to the EWMS condition will report comparable levels of treatment satisfaction on the Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979) as other efficacy trials using expressive writing paradigms (Sloan et al., 2012).

    Measured: Veterans will complete the Client Satisfaction Questionnaire at the post-treatment (3-4 weeks after beginning treatment) assessment

Secondary outcomes (2)
  1. Depressive symptom severity on the Patient Health Questionnaire-9 (PHQ-9)

    The PHQ is a 9-item self-report measure of depression symptoms, and includes an item assessing suicidal ideation. Administered at baseline, posttreatment, and follow-up.

    Repeated measures analysis of variance (ANOVA) models will be used to detect group mean differences in depression symptom severity at the 3-month follow-up. The investigators will treat time (baseline, post-treatment, 3-month follow-up) as the within variable and group (i.e., EWMS vs. neutral control) as the between variable, and include the interaction of time and condition in the model. If the interaction between time and condition is significant, the investigators will conduct post hoc analysis with a Bonferroni adjustment to compare group mean differences in depressive symptom severity.

    Measured: baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up

  2. Anxiety symptom severity based on the Generalized Anxiety Disorder-7 (GAD-7)

    The GAD7 is a 7-item self-report measure of anxiety symptoms. Administered at baseline, posttreatment, and follow-up.

    Repeated measures analysis of variance (ANOVA) models will be used to detect group mean differences in anxiety symptom severity at the 3-month follow-up. The investigators will treat time (baseline, post-treatment, 3-month follow-up) as the within variable and group (i.e., EWMS vs. neutral control) as the between variable, and include the interaction of time and condition in the model. If the interaction between time and condition is significant, the investigators will conduct post hoc analysis with a Bonferroni adjustment to compare group mean differences in anxiety symptom severity.

    Measured: baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start20 Mar 2024
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In Phase I, all sexual minority Veterans will receive EWMS, which will be iteratively refined based on qualitative interviews at end of treatment, consultation with experts in sexual minority health (Dr. Livingston and SMEs, Drs. Sloan and Pachankis) and discussion amongst mentors (Drs. Marx, Livingston, and Iverson). In Phase II, sexual minority Veterans who are eligible (i.e., clinically significant depression and/or anxiety symptoms and a history of sexual minority stressor exposure that is reported by Veterans to be related to their distress) will be randomized to the EWMS condition or to the neutral control condition. Participants will complete the assigned intervention condition and will be assessed at baseline, post-treatment, and 3 month follow-up.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897021
Sponsor's protocol ID
MHBC-008-22F
Other IDs
IK2CX002629
Acronym
EWMS
Status last verified
Jan 2026
First submitted
1 Jun 2023
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Writing on Minority Stressors and Neutral Writing in people with Depressive Symptoms and Anxiety, run by VA Office of Research and Development 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kelly L Harper, PhD ((857) 364-4417, kelly.harper@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Expressive Writing on Minority Stressors (EWMS) intervention (time frame: This will be assessed through study completion at the end of Phase II of the Study (i.e., end of the 4th year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Feb 2026.

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