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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)
Awards & highlights
EWMS Trial 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.Check my eligibility
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.See study design
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.
EWMS Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the Expressive Writing on Minority Stressors (EWMS) intervention
Patient satisfaction with the Expressive Writing on Minority Stressors (EWMS) intervention
Secondary outcome measures
Anxiety symptom severity based on the Generalized Anxiety Disorder-7 (GAD-7)
Depressive symptom severity on the Patient Health Questionnaire-9 (PHQ-9)
EWMS 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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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,199 Total Patients Enrolled
17 Trials studying Anxiety
2,001 Patients Enrolled for Anxiety
Kelly L Harper, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran with significant cognitive issues due to a brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Expressive Writing on Minority Stressors
- Group 2: Neutral Writing
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this clinical trial?
"Presently, clinicaltrials.gov does not show this particular trial actively searching for participants after its initial posting on October 1st 2023 and last update on June 1st 2023. However, there are still 1603 other studies accepting applicants at the present moment."
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