The Challenge of Clinical Research and Suicidality: Participant Feedback on a Safety Protocol

Rachel Vanderkruik, PhD, MSc; Marlene P. Freeman, MD; Katherine A. Dunn, BS; Charlotte A. Clifford, BA; Sona Dimidjian, PhD; Lee S. Cohen, MD

J Clin Psychiatry 2023;84(4):22m14737

ABSTRACT

Objective: Clinical studies of depression have historically excluded participants with suicidal ideation. Research participant safety protocols are critical to allow for the much-needed study of suicide risk. This report summarizes participant feedback about the safety protocol used in a national, remote study of perinatal women with suicidal ideation.

Methods: Upon completion of the study, participants who had triggered the suicidality safety protocol during the study were invited to complete a brief survey with questions about their experiences with the protocol. The survey included 4 Likert-scale questions and 1 open text question where participants could provide feedback, suggestions, and comments to the research team. Participant feedback survey data were collected between October 2021 and April 2022, and this research was funded by the National Institute of Mental Health.

Results: Of the 45 participants enrolled in the UPWARD-S study, 16 triggered the safety protocol. All eligible participants (N = 16) completed the survey. Among respondents, most were at least neutral to very comfortable with the call from the study psychiatrist (75% [n = 12]) and reported that the call had a “positive impact” on their well-being (69% [n = 11]). After the call with the study psychiatrist, 50% of participants (n = 8) reported that they increased engagement with treatment for depression, and the other 50% reported no change in treatment. We also report on themes from the qualitative feedback regarding suggestions of how to modify or improve the safety protocol.

Conclusions: Learning from the experiences of research participants will provide unique insight into satisfaction with, and impact of, the implemented suicidality safety protocol. Findings from this study could inform the refinement and implementation of safety protocols used in depression studies as well as future research on the impact of such protocols.

Continue Reading...

Did you know members enjoy unlimited free PDF downloads as part of their subscription? Subscribe today for instant access to this article and our entire library in your preferred format. Alternatively, you can purchase the PDF of this article individually.

Subscribe Now

Already a member? Login

Purchase PDF for $40

Members enjoy free PDF downloads on all articles. Join today

References (11)

Cai H, Xie X-M, Zhang Q, et al. Prevalence of suicidality in major depressive disorder: a systematic review and meta-analysis of comparative studies. Front Psychiatry. 2021;12:690130. PubMed CrossRef
Ballard ED, Snider SL, Nugent AC, et al. Active suicidal ideation during clinical antidepressant trials. Psychiatry Res. 2017;257:303–308. PubMed CrossRef
Courtet P, Nobile B. Inclusion of suicidal individuals in research studies. J Clin Psychiatry. 2020;81(3):20com13276. PubMed CrossRef
Iltis AS, McCall WV, Deria R. Suicidality, depression, and the FDA: health inequities and the ethical conduct of research. J Clin Psychiatry. 2020;81(2):19m13050. PubMed CrossRef
Bentley KH, Maimone JS, Kilbury EN, et al. Practices for monitoring and responding to incoming data on self-injurious thoughts and behaviors in intensive longitudinal studies: A systematic review. Clin Psychol Rev. 2021;90:102098. PubMed CrossRef
Schatten HT, Gaudiano BA, Primack JM, et al. Monitoring, assessing, and responding to suicide risk in clinical research. J Abnorm Psychol. 2020;129(1):64–69. PubMed CrossRef
Ali J, Morain SR, O’Rourke PP, et al. Responding to signals of mental and behavioral health risk in pragmatic clinical trials: ethical obligations in a healthcare ecosystem. Contemp Clin Trials. 2022;113:106651. PubMed CrossRef
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. PubMed CrossRef
Posner K, Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–1277. PubMed CrossRef
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–1288. PubMed CrossRef
Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001;52(6):828–833. PubMed CrossRef