Analysis of Recruitment Strategies: Enrolling Veterans With PTSD Into a Clinical Trial

Roberge, Erika M.; Benedek, David M.; Marx, Christine E.; Rasmusson, Ann M.; Lang, Ariel J.

doi:10.1037/mil0000178

Cited by 3 publications

(2 citation statements)

References 21 publications

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“…In previous studies, online and media advertising was the most frequent recruiting source in a trial involving adolescents with PTSD [ 28 ]. Additionally, clinician referral was the most effective method for identifying eligible and willing participants in a trial enrolling veterans with PTSD [ 29 ]. Recognizing potential participant pathways into the study enrollment is also essential to enhance the recruitment rate and address barriers [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study

Choi,

Kim,

Kwon

et al. 2024

J Pharmacopuncture

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Objectives Posttraumatic stress disorder (PTSD) is a prevalent mental health condition, and techniques using sensory stimulation in processing traumatic memories have gained attention. The Emotional Freedom Techniques (EFT) is a psychotherapy that combines tapping on acupoints with exposure to cognitive reframing. This pilot study aimed to assess the feasibility of EFT as a treatment for PTSD by answering the following research questions 1) What is the compliance and completion rate of patients with PTSD with regard to EFT protocol? Is the dropout rate reasonable? 2) Is the effect size of EFT protocol for PTSD sufficient to justify a future trial? Methods Thirty participants diagnosed with PTSD were recruited. They received weekly EFT sessions for five weeks, in which they repeated a statement acknowledging the problem and accepting themselves while tapping the SI3 acupoint on the side of their hand. PTSD symptoms were evaluated using the PTSD Checklist for DSM-5 (PCL-5) before and after the intervention. Results Of the 30 PTSD patients (mean age 34.1 ± 9.1, 80% female), 96.7% showed over 80% compliance to the EFT sessions, and 86.7% completed the entire study process. The mean PCL-5 total score decreased significantly after the intervention, with a large effect size (change from baseline –14.33 [95% CI –19.79, –8.86], p < 0.0001, d = 1.06). Conclusion The study suggests that EFT is a feasible treatment for PTSD, with high session compliance and low dropout rates. The effect size observed in this study supports the need for a larger trial in the future to further investigate EFT as a treatment for PTSD. However, the lack of a control group and the use of a self-rated questionnaire for PTSD symptoms are limitations of this study. The findings of this pilot study can be used to plan a future trial.

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Section: Discussionmentioning

confidence: 99%

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study

Choi,

Kim,

Kwon

et al. 2024

J Pharmacopuncture

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“…Whilst these results are promising, RCT studies are needed to properly assess the value of RTM as a potentially cost-effective and acceptable treatment for PTSD in a UK veteran population. Furthermore, veterans are challenging to recruit, randomise, and retain into mental health treatment studies [16]. The PTSD Experimental Treatment Trial (PETT Study) aimed to determine the feasibility of a research protocol for evaluating RTM compared to TFCBT in military veterans in order to inform an efficacy trial.…”

Section: Introductionmentioning

confidence: 99%

Reconsolidation of traumatic memories protocol compared to trauma-focussed cognitive behaviour therapy for post-traumatic stress disorder in UK military veterans: a randomised controlled feasibility trial

Sturt,

Rogers,

Armour

et al. 2023

Pilot Feasibility Stud

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Background Post-traumatic stress disorder (PTSD) occurs more commonly in military veterans than the general population. Whilst current therapies are effective, up to half of veterans commencing treatment do not complete it. Reconsolidation of Traumatic Memories (RTM) protocol is a novel, easy to train, talking therapy with promising findings. We examine the feasibility of undertaking an efficacy trial of RTM in veterans. Methods A parallel group, single-centre randomised controlled feasibility trial with a post-completion qualitative interview study. Sixty military veterans were randomised 2:1 to RTM (n = 35) or Trauma Focussed Cognitive Behaviour Therapy (CBT) (n = 25). We aimed to determine the rate of recruitment and retention, understand reasons for attrition, determine data quality and size of efficacy signal. We explored veterans’ perceptions of experiences of joining the trial, the research procedures and therapy, and design improvements for future veteran studies. Military veterans with a diagnosis of PTSD or complex PTSD, and clinically significant symptoms, were recruited between January 2020 and June 2021. Primary outcome was feasibility using pre-determined progression criteria alongside PTSD symptoms, with depression, recovery, and rehabilitation as secondary outcomes. Data were collected at baseline, 6, 12, and 20 weeks. Interviews (n = 15) were conducted after 20 weeks. Both therapies were delivered by trained charity sector provider therapists. Results Participants’ mean age was 53 years, the mean baseline PTSD symptoms score assessed by the Post-traumatic Stress Checklist (PCL-5) was 57 (range 0–80). Fifty had complex PTSD and 39 had experienced ≥ 4 traumas. Data were analysed at 20 weeks for feasibility outcomes (n = 60) and mental health outcomes (n = 45). Seven of eight progression criteria were met. The RTM group experienced a mean 18-point reduction on the PCL-5. TFCBT group participants experienced a mean reduction of eight points. Forty-eight percent of the RTM group no longer met diagnostic criteria for PTSD compared to 16% in the TFCBT group. All veterans reported largely positive experiences of the therapy and research procedures and ways to improve them. Conclusion RTM therapy remains a promising psychological intervention for the treatment of PTSD, including complex PTSD, in military veterans. With specific strengthening, the research protocol is fit for purpose in delivering an efficacy trial. Trial registration ISRCTN registration no 10314773 on 01.10.2019. Full trial protocol: available on request or downloadable at ISRCTN reg. no. 10314773.

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How can we get Iraq- and Afghanistan-deployed US Veterans to participate in health-related research? Findings from a national focus group study

Littman

True

Ashmore

et al. 2018

BMC Med Res Methodol

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BackgroundResearch participant recruitment is often fraught with obstacles. Poor response rates can reduce statistical power, threaten both internal and external validity, and increase study costs and duration. Military personnel are socialized to a specific set of laws, norms, traditions, and values; their willingness to participate in research may differ from civilians. The aims of this study were to better understand the views of United States (US) Veterans who served in Operation Enduring Freedom (OEF)/ Operation Iraqi Freedom (OIF) on research and motivators for participating in research to inform recruitment for a planned observational study of respiratory health in OEF/OIF Veterans.MethodsWe conducted 10 focus groups in a purposive sample of OEF/OIF Veterans (n = 89) in five US cities in 2015. Key topics included: reasons for participating or declining to participate in health-related research, logistics around study recruitment and conduct, compensation, written materials, and information sharing preferences for study results. Two authors independently coded the data using template analysis.ResultsParticipants identified three criteria that motivated a decision to participate in health-related research: 1) adequate compensation, 2) desire to help other Veterans, and 3) significance and relevance of the research topic. For many, both sufficient compensation and a sense that the study would help other Veterans were critical. The importance of transparency arose as a key theme; Veterans communicated that vague language about study aims or procedures engendered distrust. Lastly, participants expressed a desire for studies to communicate results of their specific health tests, as well as overall study findings, back to research participants.ConclusionsOEF/OIF Veterans described trust, transparent communication, and respect as essential characteristics of research in which they would be willing to participate. Additional studies are needed to determine whether our results generalize to other US Veterans; nevertheless, our results highlight precepts that have been reported as important for recruitment in other populations. Researchers may benefit from using community-engaged research methods to seek feedback on recruitment materials and strategies prior to initiating research. For costly studies targeting a large sample (i.e. in the thousands), it may be important to test a variety of recruitment strategies.Electronic supplementary materialThe online version of this article (10.1186/s12874-018-0546-2) contains supplementary material, which is available to authorized users.

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Analysis of Recruitment Strategies: Enrolling Veterans With PTSD Into a Clinical Trial

Cited by 3 publications

References 21 publications

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study

Feasibility of Emotional Freedom Techniques in Patients with Posttraumatic Stress Disorder: a pilot study

Reconsolidation of traumatic memories protocol compared to trauma-focussed cognitive behaviour therapy for post-traumatic stress disorder in UK military veterans: a randomised controlled feasibility trial

How can we get Iraq- and Afghanistan-deployed US Veterans to participate in health-related research? Findings from a national focus group study

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