- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05897021
Expressive Writing on Minority Stressors Among Sexual Minority Veterans (EWMS)
Expressive Writing to Reduce Depressive and Anxiety Symptoms Among Sexual Minority Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brian P Marx, PhD
- Phone Number: (857) 364-6071
- Email: brian.marx@va.gov
Study Contact Backup
- Name: Kelly L Harper, PhD
- Phone Number: (857) 364-4417
- Email: kelly.harper@va.gov
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02130-4817
- Recruiting
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
Contact:
- Brian P Marx, PhD
- Phone Number: (857) 364-6071
- Email: brian.marx@va.gov
-
Contact:
- Kelly L Harper, PhD
- Phone Number: 857-364-4417
- Email: kelly.harper@va.gov
-
Principal Investigator:
- Kelly L Harper, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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 based on endorsement of at least one item on a modified version of the Everyday Discrimination Scale (EDS) that is contributing to distress per Veteran report ('yes' on EDS item 11)
- be stable on psychotropic medication for at least 4 weeks if on a psychotropic medication
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Expressive Writing on Minority Stressors
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.
|
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.
|
Placebo Comparator: Neutral Writing
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
Time Frame: Veterans will complete the Client Satisfaction Questionnaire at the post-treatment (3-4 weeks after beginning treatment) assessment
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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).
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Veterans will complete the Client Satisfaction Questionnaire at the post-treatment (3-4 weeks after beginning treatment) assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety symptom severity based on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up
|
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. |
baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up
|
Depressive symptom severity on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up
|
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. |
baseline, post-treatment (3-4 weeks after beginning treatment), and 3-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kelly L Harper, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHBC-008-22F
- IK2CX002629 (U.S. NIH Grant/Contract: VA Clinical Science Research & Development)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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