Expressive Writing on Minority Stressors Among Sexual Minority Veterans

NCT05897021 | Recruiting DMC

• 2 other identifiers: MHBC-008-22FIK2CX002629
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depressive Symptoms; Anxiety

Keywords

Sexual Minorities; Veterans; Depressive Symptoms; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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).

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

Secondary Outcomes (2)

• Depressive symptom severity on the Patient Health Questionnaire-9 (PHQ-9)

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

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

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

Study Arms (2)

Expressive Writing on Minority Stressors

EXPERIMENTAL

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.

Behavioral: Expressive Writing on Minority Stressors

Neutral Writing

PLACEBO COMPARATOR

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.

Behavioral: Neutral Writing

Interventions

Expressive Writing on Minority Stressors BEHAVIORAL

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.

Expressive Writing on Minority Stressors

Neutral Writing BEHAVIORAL

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.

Neutral Writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Kelly L Harper, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly L Harper, PhD

CONTACT

(857) 364-4417; kelly.harper@va.gov

Brian P Marx, PhD

CONTACT

(857) 364-6071; brian.marx@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors will be independent from the Study Team and will be blind to participants' treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: March 20, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)