Project QueST 2023: Queer Survivors of Trauma

NCT ID: NCT05569915

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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This study aims to provide a novel method for adapting and testing evidence-based expressive writing (EW) treatments for trauma-exposed sexual minority women (SMW) and gender diverse individuals. The investigators will (1) describe the development and components of the proposed EW treatments, (2) discuss our plan for evaluating acceptability and feasibility of the proposed study, (3) identify steps for characterizing preliminary efficacy of EW treatments in reducing PTSD symptom severity and hazardous drinking levels compared to control, and (4) highlight our strategy for preliminarily evaluating mediators and moderators of treatment efficacy.

Conditions

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Stress Disorders, Post-Traumatic Drinking Heavy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Trauma Expressive Writing

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.

Group Type EXPERIMENTAL

Trauma Expressive Writing

Intervention Type 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.

Stigma Expressive Writing

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.

Group Type EXPERIMENTAL

Stigma Expressive Writing

Intervention Type 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.

Control

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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.

Interventions

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Trauma Expressive Writing

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

Intervention Type BEHAVIORAL

Stigma Expressive Writing

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* failing an inclusion criterion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Syracuse University

OTHER

Sponsor Role lead

Responsible Party

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Jillian Scheer

Assistant Professor, Cobb-Jones Professor Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jillian R Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Syracuse University

Locations

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Syracuse University

Syracuse, New York, United States

Site Status

Countries

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United States

References

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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

Reference Type 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

Reference Type 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

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 33764114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30407029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25682718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34802777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16389062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16250744 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11785588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11519772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11914441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21319899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6668417 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 6622612 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 20013458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16285214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17437384 (View on PubMed)

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.

Reference Type RESULT
PMID: 26691504 (View on PubMed)

Other Identifiers

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20-306

Identifier Type: -

Identifier Source: org_study_id

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