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Expressive Writing for Depression and Anxiety (EWMS Trial)

N/A

Recruiting

Led By Kelly L Harper, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed through study completion at the end of phase ii of the study (i.e., end of the 4th year)

Summary

This trial will evaluate a writing intervention aimed at reducing depressive and anxiety symptoms in sexual minority Veterans. It has potential to improve the quality of care for a vulnerable population.

Who is the study for?

This trial is for sexual minority Veterans experiencing significant depression or anxiety, who have faced discrimination due to their sexuality. They must score above 10 on specific mental health scales and identify as non-heterosexual. Those with severe substance use disorders, cognitive impairments, suicidal plans/intent, or unstable mania/psychosis cannot participate.

What is being tested?

The study tests a brief expressive writing intervention aimed at reducing distress from sexual minority stressors versus neutral writing. It involves three sessions designed for sexual minority Veterans to see if it can lessen symptoms of depression and anxiety.

What are the potential side effects?

While not explicitly listed in the provided information, expressive writing interventions may sometimes lead to temporary increases in distress due to recalling stressful events but are generally considered low-risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed through study completion at the end of phase ii of the study (i.e., end of the 4th year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed through study completion at the end of phase ii of the study (i.e., end of the 4th year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed through study completion at the end of phase ii of the study (i.e., end of the 4th year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Expressive Writing on Minority StressorsExperimental Treatment1 Intervention

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.

Group II: Neutral WritingPlacebo Group1 Intervention

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.

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