Project QueST 2023: Queer Survivors of Trauma

NCT05569915 | Completed

• 1 other identifier: 20-306
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the initial efficacy of tailored online writing interventions specifically designed for sexual minority women, transgender individuals, and/or nonbinary people to target the primary outcomes: posttraumatic stress disorder (PTSD) symptom severity and hazardous drinking.

Conditions

Stress Disorders, Post-Traumatic; Drinking Heavy

Keywords

sexual trauma; PTSD symptoms; coping; LGBTQ; lesbian; bisexual; Sexual and Gender Minorities; Alcohol-Related Disorders

Outcome Measures

Primary Outcomes (4)

• Change in PTSD symptom severity

  Posttraumatic stress disorder (PTSD) symptoms will be measured with the Psychometric Properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). The PDS-5 is a 24-item self-report measure designed to assess the severity of DSM-5 PTSD symptoms. The 24-item scale comprises a checklist of traumatic event types the individual has experienced, identification of the most distressing traumatic event, and an assessment of PTSD symptoms. The assessment of PTSD symptoms yields a total score and three subscales (re-experiencing, avoidance, and arousal), and a cutoff score of 28 or higher indicates a probable PTSD diagnosis. Items are scored 1 = once a week or less/a little to 4 = 6 or more times a week/severe. At baseline and 3-month follow-up assessments, participants will complete the PDS-5 in reference to the past month. At the one-week follow-up assessment, participants will complete the PDS-5 in reference to the past week.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in hazardous drinking levels

  The Alcohol Use Disorders Identification Test (AUDIT) will be used to measure hazardous drinking levels. The AUDIT is a 10-item screening measure of problematic alcohol use with individual items ranging from 0 to 4. Scores of 8 and higher are thought to reflect hazardous alcohol use. At baseline and 3-month follow-up assessments, participants will complete the AUDIT in reference to the past month.

  Baseline (Pre-intervention) and Three-month Follow-up (3 months post first treatment session)

• Change in drinking quantity

  To assess drinking quantity in the past week, the investigators will ask participants one question that assesses retrospective estimates for number of drinks consumed on average (in a typical week). The investigators will assess change in the total number of drinks consumed on a typical week in the past month from baseline to total number of drinks consumed in the past week at one-week follow-up and from baseline to total number of drinks consumed in a typical week in the past month at 3-months follow-up assessment. At baseline and 3-month follow-up assessments, participants will complete the hazardous drinking quantity question in reference to a typical week during the past month. At the one-week follow-up assessment, participants will complete the hazardous drinking quantity question in reference to the past week.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in heavy drinking frequency

  The investigators will assess the number of heavy drinking days (days where participants assigned female or intersex at birth consume ≥4 standard drinks and participants assigned male at birth consume ≥5 standard drinks). Response options range from 0 = never to 4 = almost every day where higher scores represent greater heavy drinking frequency. The investigators will assess change in frequency of heavy drinking days in the past month from baseline to frequency of heavy drinking days in the past week at one-week follow-up and from baseline to frequency of heavy drinking days in the past month at 3-months follow-up. At baseline and 3-month follow-up assessments, participants will report frequency of heavy drinking days over the past month. At the one-week follow-up assessment, participants will report frequency of heavy drinking days over the past week.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

Secondary Outcomes (19)

• Change in trauma centrality.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in coping.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in sexual minority identity-related experiences

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in perceived stress.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

• Change in depression and anxiety symptoms.

  Baseline (Pre-intervention), Immediate Post-intervention (1 week post first treatment session), and Three-month Follow-up (3 months post first treatment session)

Study Arms (3)

Trauma Expressive Writing

EXPERIMENTAL

In the trauma condition, we ask participants to write about a traumatic experience, prompting them to write their very deepest thoughts and feelings about the most traumatic experience of their entire life or an extremely important stressful, upsetting, or emotional issue that has affected them.

Behavioral: Trauma Expressive Writing

Stigma Expressive Writing

EXPERIMENTAL

In the stigma condition, we ask participants to write about an experience of stigma, prompting them to write about their very deepest thoughts and feelings about the most difficult or painful experience of stigma or bias (e.g., prejudice, bullying, rejection, discrimination) based on one or more of their identities (e.g., race/ethnicity, gender identity, sexual identity, religion) that they have faced.

Behavioral: Stigma Expressive Writing

Control

PLACEBO COMPARATOR

In the control condition, we ask participants to write about their day, prompting them to write about what they did yesterday from the time they got up until the time they went to bed.

Behavioral: Control

Interventions

Trauma Expressive Writing BEHAVIORAL

Participants assigned to the trauma condition will write about an experience of trauma for 15 to 20 minutes per day across five consecutive days.

Trauma Expressive Writing

Stigma Expressive Writing BEHAVIORAL

Participants assigned to the stigma condition will write about an experience of stigma or bias for 15 to 20 minutes per day across five consecutive days.

Stigma Expressive Writing

Control BEHAVIORAL

Participants assigned to the control condition will write about their days for 15 to 20 minutes per day across five consecutive days. This control condition is standard across many expressive writing studies.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women who are assigned female at birth, transgender men or women, and nonbinary people regardless of sex assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being at least 18 years of age
• reporting English fluency
• identifying as sexual minority women, inclusive of gender-diverse people
• living in the United States (US)
• reporting one or more Criterion A traumatic events
• having internet and email access
• not having received inpatient psychiatric support in the past six months

Sponsors & Collaborators

• Yale University: collaborator
• Massachusetts General Hospital: collaborator
• Syracuse University: lead

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

Related Publications (22)

• World Health Organization, Babor, Thomas F., Higgins-Biddle, John C., Saunders, John B. Monteiro, Maristela G. AUDIT: The Alcohol Use Disorders Identification Test: Guidelines for use in primary health care, 2nd ed. World Health Organization. 2001. https://apps.who.int/iris/handle/10665/67205

  BACKGROUND

• Dalenberg C, Carlson E. New versions of the Dissociative Experiences Scale: The DES-R (revised) and the DES-B (brief). Paper presented at the International Society for Traumatic Stress Studies Annual Meeting. 2010;26:203. https://istss.org/meetings-events/meeting-archives/2010-annual-meeting-archives.aspx

  BACKGROUND

• Preece D, Becerra R, Robinson K, Dandy J, Allan A. The psychometric assessment of alexithymia: Development and validation of the Perth Alexithymia Questionnaire. Pers Individ Dif. 2018;132:32-44. doi: 10.1016/j.paid.2018.05.011

  BACKGROUND

• Salomon K, Bosson JK, El-Hout M, Kiebel E, Kuchynka SL, Shepard SL. The Experiences with Ambivalent Sexism Inventory (EASI). Basic Appl Soc Psychol. 2020;42(4):235-253. doi: 10.1080/01973533.2020.1747467

  BACKGROUND

• Tebbe EA, Moradi B, Wilson E, Bell HL, Connelly K, Lenzen A. Development and psychometric evaluation of the Sexual Minority Women's Sexual Objectification Experiences Scale. J Couns Psychol. 2021 Oct;68(5):501-514. doi: 10.1037/cou0000547. Epub 2021 Mar 25.

  PMID: 33764114 BACKGROUND

• Gomez JM. What's the harm? Internalized prejudice and cultural betrayal trauma in ethnic minorities. Am J Orthopsychiatry. 2019;89(2):237-247. doi: 10.1037/ort0000367. Epub 2018 Nov 8.

  PMID: 30407029 BACKGROUND

• Hildebrand M. The Psychometric Properties of the Drug Use Disorders Identification Test (DUDIT): A Review of Recent Research. J Subst Abuse Treat. 2015 Jun;53:52-9. doi: 10.1016/j.jsat.2015.01.008. Epub 2015 Jan 31.

  PMID: 25682718 BACKGROUND

• Carter G, Yu Z, Aryana Bryan M, Brown JL, Winhusen T, Cochran G. Validation of the tobacco, alcohol, prescription medication, and other substance use (TAPS) tool with the WHO alcohol, smoking, and substance Involvement screening test (ASSIST). Addict Behav. 2022 Mar;126:107178. doi: 10.1016/j.addbeh.2021.107178. Epub 2021 Nov 10.

  PMID: 34802777 BACKGROUND

• Berntsen D, Rubin DC. The centrality of event scale: a measure of integrating a trauma into one's identity and its relation to post-traumatic stress disorder symptoms. Behav Res Ther. 2006 Feb;44(2):219-31. doi: 10.1016/j.brat.2005.01.009.

  PMID: 16389062 BACKGROUND

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.

  PMID: 16250744 BACKGROUND

• Neff, K. D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250.

  BACKGROUND

• Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.

  PMID: 11785588 BACKGROUND

• Gandhi SK, Salmon JW, Zhao SZ, Lambert BL, Gore PR, Conrad K. Psychometric evaluation of the 12-item short-form health survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials. Clin Ther. 2001 Jul;23(7):1080-98. doi: 10.1016/s0149-2918(01)80093-x.

  PMID: 11519772 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 BACKGROUND

• Mohr JJ, Kendra MS. Revision and extension of a multidimensional measure of sexual minority identity: the Lesbian, Gay, and Bisexual Identity Scale. J Couns Psychol. 2011 Apr;58(2):234-245. doi: 10.1037/a0022858.

  PMID: 21319899 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

  PMID: 6622612 BACKGROUND

• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment, 26(1), 41-54.

  BACKGROUND

• Verdejo-Garcia A, Lozano O, Moya M, Alcazar MA, Perez-Garcia M. Psychometric properties of a Spanish version of the UPPS-P impulsive behavior scale: reliability, validity and association with trait and cognitive impulsivity. J Pers Assess. 2010 Jan;92(1):70-7. doi: 10.1080/00223890903382369.

  PMID: 20013458 BACKGROUND

• Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.

  PMID: 16285214 BACKGROUND

• Wei M, Russell DW, Mallinckrodt B, Vogel DL. The Experiences in Close Relationship Scale (ECR)-short form: reliability, validity, and factor structure. J Pers Assess. 2007 Apr;88(2):187-204. doi: 10.1080/00223890701268041.

  PMID: 17437384 BACKGROUND

• Foa EB, McLean CP, Zang Y, Zhong J, Powers MB, Kauffman BY, Rauch S, Porter K, Knowles K. Psychometric properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). Psychol Assess. 2016 Oct;28(10):1166-1171. doi: 10.1037/pas0000258. Epub 2015 Dec 21.

  PMID: 26691504 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sexual Trauma; Homosexuality, Female; Bisexuality; Coitus; Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Homosexuality; Sexuality; Sexual Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jillian R Scheer, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cobb-Jones Professor Clinical Psychology

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: June 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion for three years.
• Access Criteria: Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.

Locations

US (1)