Depression Clinical Trial
Official title:
App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: A Randomized Control Trial
Verified date | May 2023 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the United States, people of color (POC) are disproportionally affected by stressors related to race/ethnicity compared with their non-Latinx White (NLW). Considering POC exposed to race-related stress are at high risk of developing a mental health disorder, there is a clear need for treatments that allow individuals to cope effectively with these stressors. Among many evidence-based treatments available, mindfulness-based interventions (MBIs) may be particularly well suited to help POC cope. MBIs are hypothesized to be effective via increases in mindfulness and self-compassion, as well as reductions in experiential avoidance, rumination, and emotion suppression. Despite their effectiveness, MBIs rarely reach POC. As such, innovative strategies such as self-directed app-based intervention may reduce the treatment gap. Considering the lack of research examining the effectiveness of MBIs among POC, especially those who experience elevated levels of race-related stress, this study will employ a randomized control trial (RCT) approach to examine whether receiving an app-based MBI engages the hypothesized mechanisms of change (i.e., mindfulness, self-compassion, experiential avoidance, rumination, emotion suppression) among POC. Similarly, the study will test whether the intervention leads to decreases in the negative mental health outcomes more often associated with exposure to race-related stress (i.e., stress, anxiety, depression). Acceptability, adherence, and satisfaction also will be analyzed to explore whether a non-culturally adapted MBI is still relevant for POC who face race-related stress. Results from this trial will contribute to the nascent data on MBI acceptability and effectiveness with POC. To the investigators' knowledge, this study will also be the first to include a sample of POC recruited based on elevated levels of race-related stress, a high-risk population that is not commonly targeted in MBI research.
Status | Completed |
Enrollment | 155 |
Est. completion date | December 2, 2022 |
Est. primary completion date | December 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Individuals interested in participating in this study will complete an online screening questionnaire using Qualtrics, a platform that is smartphone compatible. For study inclusion, participants are required to: 1. Identify as a member of a people of color (POC) group 2. Report experiencing elevated levels of race-related stress (i.e., a score of 55 in the IRRS-B or a score of 12 in the MDM) 3. Speak and read English, 4. Not receive psychological services currently 5. Not have practiced mindfulness meditation for more than two hours in the month prior to study commencement 6. Own a smartphone with access to the internet 7. Be willing to install the MBI app and accept daily notifications and text reminders 8. Be at least 18 years old Screening Measures: Race-Related Stress. The 22-item Index of Race-Related Stress-Brief (IRRS-B) measures multiple sources of race-related stress, including Individual, Institutional, and Cultural. Participants rate items on a scale ranging from 0 (This Never Happened to Me) to 4 (This Event Happened and I was Extremely Upset), with higher scores indicating more race-related stress. The IRRS-B was developed with a POC sample (i.e., Blacks), showing adequate reliability (a = .78) for both Cultural and Individual subscales and acceptable reliability (a = .69) for the Institutional subscale. For study inclusion, participants need to obtain a score of 55, which represents elevated race-related stress. Perceived Discrimination. The 8-item Multicultural Discrimination Module (MDM) measures perceived discrimination. Participants rate items on a scale ranging from 1 (Never) to 4 (Often) with higher scores indicating more levels of perceived discrimination. The MDM was developed using a U.S. population-based sample (approximately 40% POC) and has shown good internal consistency (a = .81 - .88) in a previous study. For study inclusion, participants need to obtain a score of 12, which represents the 75th percentile of the population distribution. Exclusion Criteria: - NA |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
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University of California, Los Angeles |
United States,
Acabchuk, R. L., Simon, M. A., Low, S., Brisson, J. M., & Johnson, B. T. (2021). Measuring Meditation Progress with a Consumer-Grade EEG Device: Caution from a Randomized Controlled Trial. Mindfulness, 12(1), 68-81. https://doi.org/10.1007/s12671-020-01497-1
Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660. — View Citation
Aguilera A, Bruehlman-Senecal E, Demasi O, Avila P. Automated Text Messaging as an Adjunct to Cognitive Behavioral Therapy for Depression: A Clinical Trial. J Med Internet Res. 2017 May 8;19(5):e148. doi: 10.2196/jmir.6914. — View Citation
Aguilera A, Munoz RF. Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Prof Psychol Res Pr. 2011 Dec 1;42(6):472-478. doi: 10.1037/a0025499. — View Citation
Alkhaldi G, Hamilton FL, Lau R, Webster R, Michie S, Murray E. The Effectiveness of Prompts to Promote Engagement With Digital Interventions: A Systematic Review. J Med Internet Res. 2016 Jan 8;18(1):e6. doi: 10.2196/jmir.4790. — View Citation
Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23. — View Citation
Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567. — View Citation
Benish SG, Quintana S, Wampold BE. Culturally adapted psychotherapy and the legitimacy of myth: a direct-comparison meta-analysis. J Couns Psychol. 2011 Jul;58(3):279-89. doi: 10.1037/a0023626. — View Citation
Beshai S, Bueno C, Yu M, Feeney JR, Pitariu A. Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk. Behav Res Ther. 2020 Nov;134:103724. doi: 10.1016/j.brat.2020.103724. Epub 2020 Sep 10. — View Citation
Biggers A, Spears CA, Sanders K, Ong J, Sharp LK, Gerber BS. Promoting Mindfulness in African American Communities. Mindfulness (N Y). 2020 Oct;11(10):2274-2282. doi: 10.1007/s12671-020-01480-w. Epub 2020 Aug 21. — View Citation
Bor J, Venkataramani AS, Williams DR, Tsai AC. Police killings and their spillover effects on the mental health of black Americans: a population-based, quasi-experimental study. Lancet. 2018 Jul 28;392(10144):302-310. doi: 10.1016/S0140-6736(18)31130-9. Epub 2018 Jun 21. — View Citation
Borghouts J, Eikey E, Mark G, De Leon C, Schueller SM, Schneider M, Stadnick N, Zheng K, Mukamel D, Sorkin DH. Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions: Systematic Review. J Med Internet Res. 2021 Mar 24;23(3):e24387. doi: 10.2196/24387. — View Citation
Brake CA, Sauer-Zavala S, Boswell JF, Gallagher MW, Farchione TJ, Barlow DH. Mindfulness-Based Exposure Strategies as a Transdiagnostic Mechanism of Change: An Exploratory Alternating Treatment Design. Behav Ther. 2016 Mar;47(2):225-38. doi: 10.1016/j.beth.2015.10.008. Epub 2015 Nov 7. — View Citation
Brondolo E, Brady Ver Halen N, Pencille M, Beatty D, Contrada RJ. Coping with racism: a selective review of the literature and a theoretical and methodological critique. J Behav Med. 2009 Feb;32(1):64-88. doi: 10.1007/s10865-008-9193-0. Epub 2009 Jan 6. — View Citation
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. — View Citation
Bruehlman-Senecal E, Aguilera A, Schueller SM. Mobile Phone-Based Mood Ratings Prospectively Predict Psychotherapy Attendance. Behav Ther. 2017 Sep;48(5):614-623. doi: 10.1016/j.beth.2017.01.002. Epub 2017 Jan 9. — View Citation
Bunge E, Cook HM, Bond M, Williamson RE, Cano M, Barrera AZ, Leykin Y, Munoz RF. Comparing Amazon Mechanical Turk with unpaid internet resources in online clinical trials. Internet Interv. 2018 Apr 15;12:68-73. doi: 10.1016/j.invent.2018.04.001. eCollection 2018 Jun. — View Citation
Carter, E. R., & Murphy, M. C. (2015). Group-based Differences in Perceptions of Racism: What Counts, to Whom, and Why? Social and Personality Psychology Compass, 9(6), 269-280. https://doi.org/10.1111/spc3.12181
Carter, R. T., Johnson, V. E., Kirkinis, K., Roberson, K., Muchow, C., & Galgay, C. (2019). A Meta-Analytic Review of Racial Discrimination: Relationships to Health and Culture. Race and Social Problems, 11(1), 15-32. https://doi.org/10.1007/s12552-018-9256-y
Castellanos, R., Yildiz Spinel, M., Phan, V., Orengo-Aguayo, R., Humphreys, K. L., & Flory, K. (2020). A Systematic Review and Meta-Analysis of Cultural Adaptations of Mindfulness-Based Interventions for Hispanic Populations. Mindfulness, 11(2), 317-332. https://doi.org/10.1007/s12671-019-01210-x
Chae DH, Yip T, Martz CD, Chung K, Richeson JA, Hajat A, Curtis DS, Rogers LO, LaVeist TA. Vicarious Racism and Vigilance During the COVID-19 Pandemic: Mental Health Implications Among Asian and Black Americans. Public Health Rep. 2021 Jul-Aug;136(4):508-517. doi: 10.1177/00333549211018675. Epub 2021 May 25. — View Citation
Chiesa A, Malinowski P. Mindfulness-based approaches: are they all the same? J Clin Psychol. 2011 Apr;67(4):404-24. doi: 10.1002/jclp.20776. Epub 2011 Jan 19. — View Citation
Clarke J, Draper S. Intermittent mindfulness practice can be beneficial, and daily practice can be harmful. An in depth, mixed methods study of the "Calm" app's (mostly positive) effects. Internet Interv. 2019 Nov 16;19:100293. doi: 10.1016/j.invent.2019.100293. eCollection 2020 Mar. — View Citation
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. — View Citation
Cook BL, Trinh NH, Li Z, Hou SS, Progovac AM. Trends in Racial-Ethnic Disparities in Access to Mental Health Care, 2004-2012. Psychiatr Serv. 2017 Jan 1;68(1):9-16. doi: 10.1176/appi.ps.201500453. Epub 2016 Aug 1. — View Citation
Cooper D, Yap K, Batalha L. Mindfulness-based interventions and their effects on emotional clarity: A systematic review and meta-analysis. J Affect Disord. 2018 Aug 1;235:265-276. doi: 10.1016/j.jad.2018.04.018. Epub 2018 Apr 5. — View Citation
Cotter, E. W., & Jones, N. (2020). A Review of Latino/Latinx Participants in Mindfulness-Based Intervention Research. Mindfulness, 11(3), 529-553. https://doi.org/10.1007/s12671-019-01266-9
Craig C, Hiskey S, Spector A. Compassion focused therapy: a systematic review of its effectiveness and acceptability in clinical populations. Expert Rev Neurother. 2020 Apr;20(4):385-400. doi: 10.1080/14737175.2020.1746184. Epub 2020 Apr 10. — View Citation
Cramer H, Hall H, Leach M, Frawley J, Zhang Y, Leung B, Adams J, Lauche R. Prevalence, patterns, and predictors of meditation use among US adults: A nationally representative survey. Sci Rep. 2016 Nov 10;6:36760. doi: 10.1038/srep36760. — View Citation
Crandall A, Cheung A, Young A, Hooper AP. Theory-Based Predictors of Mindfulness Meditation Mobile App Usage: A Survey and Cohort Study. JMIR Mhealth Uhealth. 2019 Mar 22;7(3):e10794. doi: 10.2196/10794. — View Citation
Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28. — View Citation
Crowe M, Inder M, Porter R. Conducting qualitative research in mental health: Thematic and content analyses. Aust N Z J Psychiatry. 2015 Jul;49(7):616-23. doi: 10.1177/0004867415582053. Epub 2015 Apr 21. — View Citation
Cummings JR, Allen L, Clennon J, Ji X, Druss BG. Geographic Access to Specialty Mental Health Care Across High- and Low-Income US Communities. JAMA Psychiatry. 2017 May 1;74(5):476-484. doi: 10.1001/jamapsychiatry.2017.0303. — View Citation
DeLuca, S. M., Kelman, A. R., & Waelde, L. C. (2018). A Systematic Review of Ethnoracial Representation and Cultural Adaptation of Mindfulness- and Meditation-Based Interventions. Psychological Studies, 63(2), 117-129. https://doi.org/10.1007/s12646-018-0452-z
Economides M, Martman J, Bell MJ, Sanderson B. Improvements in Stress, Affect, and Irritability Following Brief Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial. Mindfulness (N Y). 2018;9(5):1584-1593. doi: 10.1007/s12671-018-0905-4. Epub 2018 Mar 1. — View Citation
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. — View Citation
Fuchs C, Lee JK, Roemer L, Orsillo SM. Using Mindfulness- and Acceptance-Based Treatments With Clients From Nondominant Cultural and/or Marginalized Backgrounds: Clinical Considerations, Meta-Analysis Findings, and Introduction to the Special Series. Cogn Behav Pract. 2013 Feb;20(1):1-12. doi: 10.1016/j.cbpra.2011.12.004. — View Citation
Fung J, Kim JJ, Jin J, Chen G, Bear L, Lau AS. A Randomized Trial Evaluating School-Based Mindfulness Intervention for Ethnic Minority Youth: Exploring Mediators and Moderators of Intervention Effects. J Abnorm Child Psychol. 2019 Jan;47(1):1-19. doi: 10.1007/s10802-018-0425-7. — View Citation
Gal E, Stefan S, Cristea IA. The efficacy of mindfulness meditation apps in enhancing users' well-being and mental health related outcomes: a meta-analysis of randomized controlled trials. J Affect Disord. 2021 Jan 15;279:131-142. doi: 10.1016/j.jad.2020.09.134. Epub 2020 Oct 7. — View Citation
Galante J, Friedrich C, Dawson AF, Modrego-Alarcon M, Gebbing P, Delgado-Suarez I, Gupta R, Dean L, Dalgleish T, White IR, Jones PB. Mindfulness-based programmes for mental health promotion in adults in nonclinical settings: A systematic review and meta-analysis of randomised controlled trials. PLoS Med. 2021 Jan 11;18(1):e1003481. doi: 10.1371/journal.pmed.1003481. eCollection 2021 Jan. — View Citation
Gamez W, Chmielewski M, Kotov R, Ruggero C, Suzuki N, Watson D. The brief experiential avoidance questionnaire: development and initial validation. Psychol Assess. 2014 Mar;26(1):35-45. doi: 10.1037/a0034473. Epub 2013 Sep 23. — View Citation
Green CA, Duan N, Gibbons RD, Hoagwood KE, Palinkas LA, Wisdom JP. Approaches to Mixed Methods Dissemination and Implementation Research: Methods, Strengths, Caveats, and Opportunities. Adm Policy Ment Health. 2015 Sep;42(5):508-23. doi: 10.1007/s10488-014-0552-6. — View Citation
Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348. — View Citation
Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31. Erratum In: Clin Psychol Rev. 2016 Nov;49:119. — View Citation
Guendelman S, Medeiros S, Rampes H. Mindfulness and Emotion Regulation: Insights from Neurobiological, Psychological, and Clinical Studies. Front Psychol. 2017 Mar 6;8:220. doi: 10.3389/fpsyg.2017.00220. eCollection 2017. — View Citation
Hall GC, Ibaraki AY, Huang ER, Marti CN, Stice E. A Meta-Analysis of Cultural Adaptations of Psychological Interventions. Behav Ther. 2016 Nov;47(6):993-1014. doi: 10.1016/j.beth.2016.09.005. Epub 2016 Sep 30. — View Citation
Hanley, A. W., Abell, N., Osborn, D. S., Roehrig, A. D., & Canto, A. I. (2016). Mind the Gaps: Are Conclusions about Mindfulness Entirely Conclusive? Journal of Counseling and Development, 94(1), 103-113. https://doi.org/10.1002/jcad.12066
Hawley, L. L., Schwartz, D., Bieling, P. J., Irving, J., Corcoran, K., Farb, N. A. S., Anderson, A. K., & Segal, Z. V. (2014). Mindfulness Practice, Rumination and Clinical Outcome in Mindfulness-Based Treatment. Cognitive Therapy and Research, 38(1), 1-9. https://doi.org/10.1007/s10608-013-9586-4
Hayes, A. M., & Feldman, G. (2004). Clarifying the Construct of Mindfulness in the Context of Emotion Regulation and the Process of Change in Therapy. Clinical Psychology: Science and Practice, 11(3), 255-262. https://doi.org/10.1093/clipsy/bph080
Hendricks, D. S., Lavery, M. R., Bouillon, L. E., & Gotfried, R. S. (2020). Evaluating the Effectiveness of a Mindfulness App Among Academic Advisors. Journal of Technology in Behavioral Science, 5(2), 149-155. https://doi.org/10.1007/s41347-019-00122-w
Hermes ED, Lyon AR, Schueller SM, Glass JE. Measuring the Implementation of Behavioral Intervention Technologies: Recharacterization of Established Outcomes. J Med Internet Res. 2019 Jan 25;21(1):e11752. doi: 10.2196/11752. — View Citation
Hernandez-Ramos R, Aguilera A, Garcia F, Miramontes-Gomez J, Pathak LE, Figueroa CA, Lyles CR. Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach. JMIR Form Res. 2021 Apr 29;5(4):e25299. doi: 10.2196/25299. — View Citation
Hinton, D. E., Pich, V., Hofmann, S. G., & Otto, M. W. (2013). Acceptance and Mindfulness Techniques as Applied to Refugee and Ethnic Minority Populations With PTSD: Examples From "Culturally Adapted CBT." Cognitive and Behavioral Practice, 20(1), 33-46. https://doi.org/10.1016/j.cbpra.2011.09.001
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. — View Citation
Huberty J, Eckert R, Larkey L, Kurka J, Rodriguez De Jesus SA, Yoo W, Mesa R. Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials. JMIR Form Res. 2019 Apr 29;3(2):e12662. doi: 10.2196/12662. — View Citation
Huey SJ Jr, Polo AJ. Evidence-based psychosocial treatments for ethnic minority youth. J Clin Child Adolesc Psychol. 2008 Jan;37(1):262-301. doi: 10.1080/15374410701820174. — View Citation
Jayewardene WP, Lohrmann DK, Erbe RG, Torabi MR. Effects of preventive online mindfulness interventions on stress and mindfulness: A meta-analysis of randomized controlled trials. Prev Med Rep. 2016 Nov 14;5:150-159. doi: 10.1016/j.pmedr.2016.11.013. eCollection 2017 Mar. — View Citation
Kachan D, Olano H, Tannenbaum SL, Annane DW, Mehta A, Arheart KL, Fleming LE, Yang X, McClure LA, Lee DJ. Prevalence of Mindfulness Practices in the US Workforce: National Health Interview Survey. Prev Chronic Dis. 2017 Jan 5;14:E01. doi: 10.5888/pcd14.160034. — View Citation
Karekla, M., Kasinopoulos, O., Neto, D. D., Ebert, D. D., Van Daele, T., Nordgreen, T., Höfer, S., Oeverland, S., & Jensen, K. L. (2019). Best Practices and Recommendations for Digital Interventions to Improve Engagement and Adherence in Chronic Illness Sufferers. European Psychologist, 24(1), 49-67. https://doi.org/10.1027/1016-9040/a000349
Kazdin AE. Annual Research Review: Expanding mental health services through novel models of intervention delivery. J Child Psychol Psychiatry. 2019 Apr;60(4):455-472. doi: 10.1111/jcpp.12937. Epub 2018 Jun 13. — View Citation
Kazdin, A. E. (2015). Technology-Based Interventions and Reducing the Burdens of Mental Illness: Perspectives and Comments on the Special Series. Cognitive and Behavioral Practice, 22(3), 359-366. https://doi.org/10.1016/j.cbpra.2015.04.004
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation
Lau, A. (2006). Making the Case for Selective and Directed Cultural Adaptations of Evidence-Based Treatments: Examples From Parent Training. Clinical Psychology: Science and Practice, 13(4), 295-310. https://doi.org/10.1111/j.1468-2850.2006.00042.x
Laurie J, Blandford A. Making time for mindfulness. Int J Med Inform. 2016 Dec;96:38-50. doi: 10.1016/j.ijmedinf.2016.02.010. Epub 2016 Mar 2. — View Citation
Lecomte T, Potvin S, Corbiere M, Guay S, Samson C, Cloutier B, Francoeur A, Pennou A, Khazaal Y. Mobile Apps for Mental Health Issues: Meta-Review of Meta-Analyses. JMIR Mhealth Uhealth. 2020 May 29;8(5):e17458. doi: 10.2196/17458. — View Citation
Lee RT, Perez AD, Boykin CM, Mendoza-Denton R. On the prevalence of racial discrimination in the United States. PLoS One. 2019 Jan 10;14(1):e0210698. doi: 10.1371/journal.pone.0210698. eCollection 2019. — View Citation
Leong FT, Kalibatseva Z. Cross-cultural barriers to mental health services in the United States. Cerebrum. 2011 Mar;2011:5. Epub 2011 Mar 23. — View Citation
Linardon J, Cuijpers P, Carlbring P, Messer M, Fuller-Tyszkiewicz M. The efficacy of app-supported smartphone interventions for mental health problems: a meta-analysis of randomized controlled trials. World Psychiatry. 2019 Oct;18(3):325-336. doi: 10.1002/wps.20673. — View Citation
Linardon J, Fuller-Tyszkiewicz M. Attrition and adherence in smartphone-delivered interventions for mental health problems: A systematic and meta-analytic review. J Consult Clin Psychol. 2020 Jan;88(1):1-13. doi: 10.1037/ccp0000459. Epub 2019 Nov 7. — View Citation
Linardon J. Can Acceptance, Mindfulness, and Self-Compassion Be Learned by Smartphone Apps? A Systematic and Meta-Analytic Review of Randomized Controlled Trials. Behav Ther. 2020 Jul;51(4):646-658. doi: 10.1016/j.beth.2019.10.002. Epub 2019 Nov 26. — View Citation
Littleton H, Grills AE, Kline KD, Schoemann AM, Dodd JC. The From Survivor to Thriver program: RCT of an online therapist-facilitated program for rape-related PTSD. J Anxiety Disord. 2016 Oct;43:41-51. doi: 10.1016/j.janxdis.2016.07.010. Epub 2016 Aug 5. — View Citation
Martinez JH, Eustis EH, Arbid N, Graham-LoPresti JR, Roemer L. The role of experiential avoidance in the relation between racial discrimination and negative mental health outcomes. J Am Coll Health. 2022 Feb-Mar;70(2):461-468. doi: 10.1080/07448481.2020.1754221. Epub 2020 May 5. — View Citation
Miller MJ, Keum BT, Thai CJ, Lu Y, Truong NN, Huh GA, Li X, Yeung JG, Ahn LH. Practice recommendations for addressing racism: A content analysis of the counseling psychology literature. J Couns Psychol. 2018 Nov;65(6):669-680. doi: 10.1037/cou0000306. Epub 2018 Aug 9. — View Citation
Miranda R, Polanco-Roman L, Tsypes A, Valderrama J. Perceived discrimination, ruminative subtypes, and risk for depressive symptoms in emerging adulthood. Cultur Divers Ethnic Minor Psychol. 2013 Oct;19(4):395-403. doi: 10.1037/a0033504. — View Citation
Mojtabai R, Olfson M, Sampson NA, Jin R, Druss B, Wang PS, Wells KB, Pincus HA, Kessler RC. Barriers to mental health treatment: results from the National Comorbidity Survey Replication. Psychol Med. 2011 Aug;41(8):1751-61. doi: 10.1017/S0033291710002291. Epub 2010 Dec 7. — View Citation
Nagayama Hall GC, Hong JJ, Zane NW, Meyer OL. Culturally-Competent Treatments for Asian Americans: The Relevance of Mindfulness and Acceptance-Based Psychotherapies. Clin Psychol (New York). 2011 Sep 1;18(3):215-231. doi: 10.1111/j.1468-2850.2011.01253.x. — View Citation
Neary M, Schueller SM. State of the Field of Mental Health Apps. Cogn Behav Pract. 2018 Nov;25(4):531-537. doi: 10.1016/j.cbpra.2018.01.002. Epub 2018 Mar 5. — View Citation
Newman, B., Merolla, J. L., Shah, S., Lemi, D. C., Collingwood, L., & Ramakrishnan, S. K. (2020). The Trump Effect: An Experimental Investigation of the Emboldening Effect of Racially Inflammatory Elite Communication. British Journal of Political Science, 1-22. https://doi.org/10.1017/S0007123419000590
Oei, T. P. S., & Green, A. L. (2008). The Satisfaction With Therapy and Therapist Scale--Revised (STTS-R) for group psychotherapy: Psychometric properties and confirmatory factor analysis. Professional Psychology: Research and Practice, 39(4), 435-442. https://doi.org/10.1037/0735-7028.39.4.435
Olano HA, Kachan D, Tannenbaum SL, Mehta A, Annane D, Lee DJ. Engagement in mindfulness practices by U.S. adults: sociodemographic barriers. J Altern Complement Med. 2015 Feb;21(2):100-2. doi: 10.1089/acm.2014.0269. — View Citation
Paradies Y, Ben J, Denson N, Elias A, Priest N, Pieterse A, Gupta A, Kelaher M, Gee G. Racism as a Determinant of Health: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 23;10(9):e0138511. doi: 10.1371/journal.pone.0138511. eCollection 2015. — View Citation
Parkerson HA, Thibodeau MA, Brandt CP, Zvolensky MJ, Asmundson GJ. Cultural-based biases of the GAD-7. J Anxiety Disord. 2015 Apr;31:38-42. doi: 10.1016/j.janxdis.2015.01.005. Epub 2015 Feb 7. — View Citation
Pascoe EA, Smart Richman L. Perceived discrimination and health: a meta-analytic review. Psychol Bull. 2009 Jul;135(4):531-54. doi: 10.1037/a0016059. — View Citation
Patel JS, Oh Y, Rand KL, Wu W, Cyders MA, Kroenke K, Stewart JC. Measurement invariance of the patient health questionnaire-9 (PHQ-9) depression screener in U.S. adults across sex, race/ethnicity, and education level: NHANES 2005-2016. Depress Anxiety. 2019 Sep;36(9):813-823. doi: 10.1002/da.22940. Epub 2019 Jul 29. — View Citation
Proulx J, Croff R, Oken B, Aldwin CM, Fleming C, Bergen-Cico D, Le T, Noorani M. Considerations for Research and Development of Culturally Relevant Mindfulness Interventions in American Minority Communities. Mindfulness (N Y). 2018 Apr;9(2):361-370. doi: 10.1007/s12671-017-0785-z. Epub 2017 Aug 16. — View Citation
Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8. — View Citation
Ramos G, Brookman-Frazee L, Kodish T, Rodriguez A, Lau AS. Community providers' experiences with evidence-based practices: The role of therapist race/ethnicity. Cultur Divers Ethnic Minor Psychol. 2021 Jul;27(3):471-482. doi: 10.1037/cdp0000357. Epub 2020 May 11. — View Citation
Ramos, G., & Chavira, D. A. (2019). Use of Technology to Provide Mental Health Care for Racial and Ethnic Minorities: Evidence, Promise, and Challenges. Cognitive and Behavioral Practice. https://doi.org/10.1016/j.cbpra.2019.10.004
Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016 Jul-Sep;7(3):144-6. doi: 10.4103/2229-3485.184823. — View Citation
Rushin, S., & Edwards, G. S. (2018). The Effect of President Trump's Election on Hate Crimes. SSRN Electronic Journal. https://doi.org/10.2139/ssrn.3102652
Schmitt MT, Branscombe NR, Postmes T, Garcia A. The consequences of perceived discrimination for psychological well-being: a meta-analytic review. Psychol Bull. 2014 Jul;140(4):921-48. doi: 10.1037/a0035754. Epub 2014 Feb 17. — View Citation
Schroder J, Sautier L, Kriston L, Berger T, Meyer B, Spath C, Kother U, Nestoriuc Y, Klein JP, Moritz S. Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. J Affect Disord. 2015 Nov 15;187:136-41. doi: 10.1016/j.jad.2015.08.044. Epub 2015 Aug 28. — View Citation
Schröder, J., Berger, T., Meyer, B., Lutz, W., Hautzinger, M., Späth, C., Eichenberg, C., Klein, J. P., & Moritz, S. (2017). Attitudes Towards Internet Interventions Among Psychotherapists and Individuals with Mild to Moderate Depression Symptoms. Cognitive Therapy and Research, 41(5), 745-756. https://doi.org/10.1007/s10608-017-9850-0
Schueller, S. M., Hunter, J. F., Figueroa, C., & Aguilera, A. (2019). Use of Digital Mental Health for Marginalized and Underserved Populations. Current Treatment Options in Psychiatry, 6(3), 243-255. https://doi.org/10.1007/s40501-019-00181-z
Schumer MC, Lindsay EK, Creswell JD. Brief mindfulness training for negative affectivity: A systematic review and meta-analysis. J Consult Clin Psychol. 2018 Jul;86(7):569-583. doi: 10.1037/ccp0000324. — View Citation
Shariff-Marco S, Breen N, Landrine H, Reeve BB, Krieger N, Gee GC, Williams DR, Mays VM, Ponce NA, Alegria M, Liu B, Willis G, Johnson TP. MEASURING EVERYDAY RACIAL/ETHNIC DISCRIMINATION IN HEALTH SURVEYS: How Best to Ask the Questions, in One or Two Stages, Across Multiple Racial/Ethnic Groups? Du Bois Rev. 2011 Spring;8(1):159-177. doi: 10.1017/S1742058X11000129. Epub 2011 Apr 15. — View Citation
Smith JL, Allen JW, Haack C, Wehrmeyer K, Alden K, Lund MB, Mascaro JS. The Impact of App-Delivered Mindfulness Meditation on Functional Connectivity and Self-Reported Mindfulness Among Health Profession Trainees. Mindfulness (N Y). 2021;12(1):92-106. doi: 10.1007/s12671-020-01502-7. Epub 2020 Oct 7. — View Citation
Smith TB, Rodriguez MD, Bernal G. Culture. J Clin Psychol. 2011 Feb;67(2):166-75. doi: 10.1002/jclp.20757. — View Citation
Sobczak, L. R., & West, L. M. (2013). Clinical Considerations in Using Mindfulness- and Acceptance-Based Approaches With Diverse Populations: Addressing Challenges in Service Delivery in Diverse Community Settings. Cognitive and Behavioral Practice, 20(1), 13-22. https://doi.org/10.1016/j.cbpra.2011.08.005
Sommers-Spijkerman M, Austin J, Bohlmeijer E, Pots W. New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-analysis of Randomized Controlled Trials. JMIR Ment Health. 2021 Jul 19;8(7):e28168. doi: 10.2196/28168. — View Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Strohmaier, S., Jones, F. W., & Cane, J. E. (2021). Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety, and Stress: a Randomized Controlled Experiment. Mindfulness, 12(1), 198-214. https://doi.org/10.1007/s12671-020-01512-5
Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116-119. doi: 10.1136/eb-2018-102891. Epub 2018 Jun 5. — View Citation
Treynor, W., Gonzalez, R., & Nolen-Hoeksema, S. (2003). Ruminative reconsiderd: A psychometric analysis. Cognitive Therapy and Research, 27(3), 247-259. https://doi.org/10.1023/A:1023910315561
Utsey, S. O. (1999). Development and Validation of a Short Form of the Index of Race-Related Stress (IRRS)-Brief Version. Measurement and Evaluation in Counseling and Development, 32(3), 149-167. https://doi.org/10.1080/07481756.1999.12068981
van der Velden AM, Kuyken W, Wattar U, Crane C, Pallesen KJ, Dahlgaard J, Fjorback LO, Piet J. A systematic review of mechanisms of change in mindfulness-based cognitive therapy in the treatment of recurrent major depressive disorder. Clin Psychol Rev. 2015 Apr;37:26-39. doi: 10.1016/j.cpr.2015.02.001. Epub 2015 Feb 11. — View Citation
Vines AI, Ward JB, Cordoba E, Black KZ. Perceived Racial/Ethnic Discrimination and Mental Health: a Review and Future Directions for Social Epidemiology. Curr Epidemiol Rep. 2017 Jun;4(2):156-165. doi: 10.1007/s40471-017-0106-z. Epub 2017 Apr 27. — View Citation
Waldron, E. M., Hong, S., Moskowitz, J. T., & Burnett-Zeigler, I. (2018). A Systematic Review of the Demographic Characteristics of Participants in US-Based Randomized Controlled Trials of Mindfulness-Based Interventions. Mindfulness, 9(6), 1671-1692. https://doi.org/10.1007/s12671-018-0920-5
Williams DR. Stress and the Mental Health of Populations of Color: Advancing Our Understanding of Race-related Stressors. J Health Soc Behav. 2018 Dec;59(4):466-485. doi: 10.1177/0022146518814251. — View Citation
Wu Y, Levis B, Riehm KE, Saadat N, Levis AW, Azar M, Rice DB, Boruff J, Cuijpers P, Gilbody S, Ioannidis JPA, Kloda LA, McMillan D, Patten SB, Shrier I, Ziegelstein RC, Akena DH, Arroll B, Ayalon L, Baradaran HR, Baron M, Bombardier CH, Butterworth P, Carter G, Chagas MH, Chan JCN, Cholera R, Conwell Y, de Manvan Ginkel JM, Fann JR, Fischer FH, Fung D, Gelaye B, Goodyear-Smith F, Greeno CG, Hall BJ, Harrison PA, Harter M, Hegerl U, Hides L, Hobfoll SE, Hudson M, Hyphantis T, Inagaki M, Jette N, Khamseh ME, Kiely KM, Kwan Y, Lamers F, Liu SI, Lotrakul M, Loureiro SR, Lowe B, McGuire A, Mohd-Sidik S, Munhoz TN, Muramatsu K, Osorio FL, Patel V, Pence BW, Persoons P, Picardi A, Reuter K, Rooney AG, Santos IS, Shaaban J, Sidebottom A, Simning A, Stafford L, Sung S, Tan PLL, Turner A, van Weert HC, White J, Whooley MA, Winkley K, Yamada M, Benedetti A, Thombs BD. Equivalency of the diagnostic accuracy of the PHQ-8 and PHQ-9: a systematic review and individual participant data meta-analysis - ERRATUM. Psychol Med. 2020 Dec;50(16):2816. doi: 10.1017/S0033291719002137. Epub 2019 Aug 19. No abstract available. — View Citation
Zvolensky MJ, Jardin C, Garey L, Robles Z, Sharp C. Acculturative stress and experiential avoidance: relations to depression, suicide, and anxiety symptoms among minority college students. Cogn Behav Ther. 2016 Nov;45(6):501-17. doi: 10.1080/16506073.2016.1205658. Epub 2016 Jul 22. — View Citation
* Note: There are 111 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in acceptability and appropriateness of the intervention | The 16-item Attitudes towards Psychological Online Interventions (APOI) measures experiences with digital interventions. Participants rate items on a scale ranging from 1 (Totally Agree) to 5 (Totally Disagree) with higher scores indicating more perceived acceptability and appropriateness. The APOI has shown good reliability (a = .83) and validity in previous studies. | Through study completion, 1-2 months | |
Other | Change in treatment adherence | Number of meditations completed, total time meditated in minutes, and number of days with at least one meditation with will be used as behavioral measures of treatment adherence. This information is tracked by the app. | Through study completion, 1-2 months | |
Other | Change in treatment satisfaction | The 7-item Satisfaction with Therapy (ST) subscale of the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measures treatment satisfaction. Participants rate items on a scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) with higher scores showing more treatment satisfaction. The ST subscale has shown excellent reliability (a = .92) and validity in a digital intervention study with a racially/ethnically diverse sample. | Through study completion, 1-2 months | |
Primary | Change in stress | The 10-item Perceived Stress Scale (PSS) measures stress. Participants rate items on a scale ranging from 0 (Never) to 4 (Very Often) with higher scores indicating more stress. The PSS has shown good reliability (a = .84 - .86) and validity, and it is commonly used in MBI research. | Through study completion, 1-2 months | |
Primary | Change in anxiety | The General Anxiety Disorder (GAD-7) measures anxiety symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe anxiety symptoms. The GAD-7 has shown good internal consistency (a = .89 - .90) and validity in POC samples. | Through study completion, 1-2 months | |
Primary | Change in depression | The 8-item Patient Health Questionnaire (PHQ-8) measures depressive symptoms. Participants rate items on a scale ranging from 0 (Not at all) to 3 (Nearly Every Day) with higher scores indicating more severe depressive symptoms.The PHQ-8 omits an item assessing suicidal ideation and self-harm included in the original PHQ-9, which makes it more adequate for self-guided digital intervention research. Furthermore, metanalytic work suggests that the PHQ-8 is practically equivalent to the original measure. The PHQ-8 has good reliability (a = .86 - .89) and has shown validity across different racial/ethnic groups. | Through study completion, 1-2 months | |
Secondary | Change in mindfulness | The 15-item Mindful Attention Awareness Scale (MAAS) measures mindfulness trait. Participants rate items using a scale ranging from 1 (Almost Always 1) to 6 (Almost Never) with higher scores indicating more mindfulness. The MAAS has shown good internal consistency (a = .80 - .87) during its development. | Through study completion, 1-2 months | |
Secondary | Change in self-Compassion | The 12-item Self-Compassion Scale, Short Form (SCS-SF) measures self-compassion trait. Participants rate items using a scale ranging from 1 (Almost Never) to 5 (Almost Always) with higher scores indicating more self-compassion. The SCS-SF has shown good internal consistency (a = .86) and validity in a sample with significant POC representation. | Through study completion, 1-2 months | |
Secondary | Change in experiential avoidance | The 15-item Brief Experiential Avoidance Questionnaire (BEAQ) measures experiential avoidance. Participants rate their responses in a scale ranging from 1 (Strongly Disagree) to 6 (Strongly Agree) with higher scores indicating higher experiential avoidance. The BAEQ has shown good internal consistency (a = .80 - .86) and construct validity. | Through study completion, 1-2 months | |
Secondary | Change in rumination | The 5-item Brooding subscale of the short version of the Ruminative Response Scale (RRS-SF) measures rumination. Participants rate their responses in a scale ranging from 1 (Almost Never) to 4 (Almost Always) with higher scores indicating more rumination. The RRS-SF Brooding subscale has shown adequate internal consistency (a = .79) and validity in studies with POC samples that experience discrimination. | Through study completion, 1-2 months | |
Secondary | Change in emotion suppression | The 4-item Expressive Suppression of the Emotion Regulation Questionnaire (ERQ) measures emotion suppression. Participants rate their responses on a scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree) with higher scores indicating more emotion suppression. The Expressive Suppression subscale of the ERQ has shown an adequate reliability (a = .68 - .76) and validity in samples with significant POC representation. | Through study completion, 1-2 months |
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