Posttraumatic Stress Disorder Clinical Trial
— WWOfficial title:
A Randomized Controlled Trial of Writing Wrongs: An Adapted Expressive Writing Intervention for Microaggressions Experienced by Minoritized Students
NCT number | NCT06276725 |
Other study ID # | 23-606 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 18, 2024 |
Est. completion date | April 1, 2025 |
Racial and ethnic based stressors, such as microaggressions, are pervasive, distressing, and result in lasting negative repercussions for minoritized students at predominantly white institutions (PWIs). These racial and ethnic based stressors are experienced in addition to the universally experienced stressors of higher education. Negative repercussions of microaggressions include increased drop out or transfer rates, distress, fatigue resulting in decreased academic performance, and depression and posttraumatic stress symptoms. Expressive writing (EW) may be a scalable intervention for addressing the negative repercussions resulting from microaggressions experienced by minoritized students at PWIs. Previous research suggests that EW for stressful life events results in benefits such as reduced depression and posttraumatic stress symptoms, improved coping strategies, and reduced activity restriction. Despite such benefits, EW was not designed to specifically address microaggressions in a minoritized student population. Informed by the ADAPT-ITT model, our research group conducted a pilot study with similar procedures. This pilot study demonstrated the acceptability of an adapted version of the EW intervention titled Writing Wrongs (WW), as well as recommended future modifications for WW. In the current study we aim to conduct a randomized-controlled trial to establish the efficacy of WW in alleviating clinical symptoms. We hypothesize that WW will improve symptoms of racial and discriminatory trauma and symptoms of depression, anxiety, and posttraumatic stress over time and compared to an assessment-only condition. We will conduct exploratory analyses to examine short-term changes in affect within and across sessions and across conditions. We will recruit minoritized students enrolled at a PWI. Participants will complete a pre-intervention assessment prior to being randomized into the two conditions. Participants in the intervention condition will engage in three sessions of WW and complete measures of clinical symptoms across multiple time points (i.e., pre-intervention, immediately after the final writing session, one week after the final session). Participants in the assessment-only condition will be administered the same measures at the same timepoints and given access to the WW after completing the study. If found to be efficacious, WW has the potential to be widely disseminated to minoritized college students who experience microaggressions.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | April 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Auburn University Full-time Student - Identifies with a Racial/Ethnic Minoritized Group Exclusion Criteria: - Under age 18 |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University | Auburn | Alabama |
Lead Sponsor | Collaborator |
---|---|
Auburn University | Medical University of South Carolina |
United States,
Andersson MA, Conley CS. Optimizing the perceived benefits and health outcomes of writing about traumatic life events. Stress Health. 2013 Feb;29(1):40-9. doi: 10.1002/smi.2423. Epub 2012 Mar 9. — View Citation
Baikie, K. A., & Wilhelm, K. (2005). Emotional and physical health benefits of expressive writing. Advances in Psychiatric Treatment, 11(5), 338-346. https://doi.org/10.1192/apt.11.5.338
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. — View Citation
Brydon, C. (2023). Adapting expressive writing for minoritized students at predominantly White institutions who experience microaggressions. [unpublished master's thesis] Auburn University.
Cokley, K., McClain, S., Enciso, A., & Martinez, M. (2013). An Examination of the Impact of Minority Status Stress and Impostor Feelings on the Mental Health of Diverse Ethnic Minority College Students. Journal of Multicultural Counseling and Development, 41(2), 82-95. https://doi.org/10.1002/j.2161-1912.2013.00029.x
Connor KM, Davidson JR. SPRINT: a brief global assessment of post-traumatic stress disorder. Int Clin Psychopharmacol. 2001 Sep;16(5):279-84. doi: 10.1097/00004850-200109000-00005. — View Citation
Cox, J. M. (2020). On Shaky Ground: Black Authenticity at Predominantly White Institutions. Social Currents, 7(2), 173-189. https://doi.org/10.1177/2329496519897605
Forkmann T, Spangenberg L, Rath D, Hallensleben N, Hegerl U, Kersting A, Glaesmer H. Assessing suicidality in real time: A psychometric evaluation of self-report items for the assessment of suicidal ideation and its proximal risk factors using ecological momentary assessments. J Abnorm Psychol. 2018 Nov;127(8):758-769. doi: 10.1037/abn0000381. Epub 2018 Oct 8. — View Citation
Grayson, P. (1998). A Fast and Bumpy Ride. Journal of College Student Psychotherapy, 13(1), 3-13. https://doi.org/10.1300/J035v13n01_02
Hernandez RJ, Villodas MT. Overcoming racial battle fatigue: The associations between racial microaggressions, coping, and mental health among Chicana/o and Latina/o college students. Cultur Divers Ethnic Minor Psychol. 2020 Jul;26(3):399-411. doi: 10.1037/cdp0000306. Epub 2019 Sep 26. — View Citation
Kim PY, Kendall DL, Cheon HS. Racial microaggressions, cultural mistrust, and mental health outcomes among asian american college students. Am J Orthopsychiatry. 2017;87(6):663-670. doi: 10.1037/ort0000203. Epub 2016 Aug 15. — View Citation
Lovibond, S. H., & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scale (2nd ed.). Psychology Foundation.
Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available. — View Citation
Ryder AG, Alden LE, Paulhus DL. Is acculturation unidimensional or bidimensional? A head-to-head comparison in the prediction of personality, self-identity, and adjustment. J Pers Soc Psychol. 2000 Jul;79(1):49-65. doi: 10.1037//0022-3514.79.1.49. — View Citation
Sloan DM, Marx BP, Epstein EM, Dobbs JL. Expressive writing buffers against maladaptive rumination. Emotion. 2008 Apr;8(2):302-6. doi: 10.1037/1528-3542.8.2.302. — View Citation
Sue DW, Capodilupo CM, Torino GC, Bucceri JM, Holder AM, Nadal KL, Esquilin M. Racial microaggressions in everyday life: implications for clinical practice. Am Psychol. 2007 May-Jun;62(4):271-86. doi: 10.1037/0003-066X.62.4.271. — View Citation
Torres-Harding SR, Andrade AL, Romero Diaz CE. The Racial Microaggressions Scale (RMAS): a new scale to measure experiences of racial microaggressions in people of color. Cultur Divers Ethnic Minor Psychol. 2012 Apr;18(2):153-164. doi: 10.1037/a0027658. — View Citation
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation
Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. (2013). Life Events Checklist for DSM-5 (LEC-5) - PTSD: National Center for PTSD. https://www.ptsd.va.gov/professional/assessment/te-measures/life_events_checklist.asp
Williams, M.T., Osman, M., Gallo, J., Pereira, D.P., Gran-Ruaz, S., Strauss, D., Lester, L., George, J.R., Edelman, J., & Litman, L. (2022). A clinical scale for the assessment of racial trauma. Practice Innovations, 7(3), 223-240. https://doi.org/10.1037/pri0000178
Williams, M.T., Printz, D.M.B., & DeLapp, R.C.T. (2018). Assessing racial trauma with the Trauma Symptoms of Discrimination Scale. Psychology of Violence, 8(6), 735-747. https://doi.org/10.1037/vio0000212
Wingood GM, DiClemente RJ. The ADAPT-ITT model: a novel method of adapting evidence-based HIV Interventions. J Acquir Immune Defic Syndr. 2008 Mar 1;47 Suppl 1:S40-6. doi: 10.1097/QAI.0b013e3181605df1. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Negative Affect | Positive and Negative Affect Scale - Negative Affect Subscale; range: 10-50; higher score is higher negative affect. | Change in negative affect across 3 sessions (each 24hrs apart) and within sessions (an average of 25 mins apart) | |
Other | Positive Affect | Positive and Negative Affect Scale - Positive Affect Subscale; range: 10-50; higher score is higher positive affect. | Change in positive affect across 3 sessions (each 24hrs apart) and within sessions (an average of 25 mins apart) | |
Other | Acceptability of Writing Wrongs | Evaluation Form | Immediate post-intervention on average 3 days after initiation of intervention | |
Primary | Racial and Discriminatory Trauma | Trauma Symptoms of Discrimination Scale; range: 0-63; higher score is greater distress associated with discrimantory experiences | Change in Trauma Symptoms of Discrimination Scale from pre-intervention to session 1 (24 hrs apart), to session 2 (24hrs from session 1), to session 3 (post-intervention, 24 hrs from session 2), and to one week follow-up (one-week from session 3) | |
Primary | Daily Racial and Discrimination Trauma | Racial Trauma Scale - Short Form; range: 9-36; higher score is greater severity of trauma symptoms specific to racial discrimination. | Change in Racial Trauma Scale - Short from pre-intervention to session 1 (24 hrs apart), to session 2 (24hrs from session 1), to session 3 (post-intervention, 24 hrs from session 2), and to one week follow-up (one-week from session 3) | |
Secondary | Depression | Depression Anxiety and Stress Scale - Depression Subscale; range: 0-21; higher score is greater severity of depressive symptoms | Change in Depression Anxiety and Stress Scale - Depression subscale from pre-intervention to post-intervention (on average 3 days apart), to one-week follow-up (one week after post-intervention). | |
Secondary | Anxiety | Depression Anxiety and Stress Scale - Anxiety Subscale; range: 0-21; higher score is greater severity of anxiety symptoms | Change in Depression Anxiety and Stress Scale - Anxiety subscale from pre-intervention to post-intervention (on average 3 days apart), to one-week follow-up (one week after post-intervention). | |
Secondary | Stress | Depression Anxiety and Stress Scale - Stress Subscale; ; range: 0-21; higher score is greater severity of stress symptoms | Change in Depression Anxiety and Stress Scale - Stress subscale from pre-intervention to post-intervention (on average 3 days apart), to one-week follow-up (one week after post-intervention). | |
Secondary | Posttraumatic Stress | Posttraumatic Stress Disorder Checklist for DSM-5; range: 0-100; higher score is greater severity of posttraumatic stress symptoms. | Change in Posttraumatic Stress Disorder Checklist for DSM-5 from pre-intervention to post-intervention (on average 3 days apart), to one-week follow-up (one week after post-intervention). | |
Secondary | Daily Depression | Ecological Momentary Assessment - Depression Subscale; range: 0-8; higher score is greater depression severity. | Change in Ecological Momentary Assessment - Depression Subscale from session 1, to session 2, to session 3 (post-intervention) | |
Secondary | Daily Anxiety | Ecological Momentary Assessment - Anxiety Subscale; range: 0-8; higher score is greater anxiety severity. | Change in Ecological Momentary Assessment - Anxiety Subscale from session 1 to session 2 (an average of 24 hrs apart), to session 3 (post-intervention; (an average of 24 hrs apart) | |
Secondary | Daily Posttraumatic Stress | Short Posttraumatic Stress Disorder Rating Interview - Self Report Form; range: 0-32; higher score is greater posttraumatic stress symptom severity. | Change in 1 Short Posttraumatic Stress Disorder Rating Interview from session 1 to session 2 (an average of 24 hrs apart), to session 3 (post-intervention; (an average of 24 hrs apart) |
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