The Use of Holographic Memory Resolution® to Improve the Physical and Biopsychosocial Symptoms of Chronic Pain: A Feasibility, Mixed Methods Study.

Objective: Holographic Memory Resolution® (HMR®), a mind-based therapy, has been used for decades as a nonpharmacologic intervention for trauma imprinting to alleviate depression, anxiety, pain, and post-traumatic stress disorder (PTSD). No clinical studies were found examining the use of HMR®. This study examined the feasibility and preliminary efficacy of administering HMR® to individuals experiencing chronic pain and related biopsychosocial symptoms. Methods: A feasibility, mixed-methods study was conducted between October 2021 and July 2022 and included four HMR® sessions over 1-12 weeks. A convenience sample was comprised of 60 adults suffering from chronic physical or emotional pain of 4+ (0-10 scale) over 6+ months at two clinics in the U.S. Baseline and subsequent surveys after sessions 2, 3, and 4 assessed symptom response. Symptoms were longitudinally measured via self-report of depression, anxiety, somatic symptom burden, PTSD, and vitality. Results: 73% completed all four sessions, demonstrating feasibility. Ages ranged from 19 to 80 years, 85% were female, and 87% were Caucasian. 52% reported high risk for toxic stress. Four symptoms decreased significantly: depression (p = 0.05), anxiety (p = 0.03), symptom burden (p < 0.01) and PTSD symptoms (p = 0.01); vitality improved. Conclusions: HMR® may be a feasible intervention to address chronic pain and accompanying biopsychosocial symptoms; a randomized controlled trial is the next step to measure efficacy. Unlike other mind-based therapies, HMR® participants use their own internal language for identification and resolution of the pain. The trauma imprinting can then be gently addressed, and the memory-based components of pain resolved or reduced, which empowers participants to improve their well-being. Trial registration: ClinicalTrials.gov Identifier: NCT05001399.

Strengths and opportunities to clinical trial enrollment among BIPOC, rural dwelling patients in the northwest United States: a retrospective study.

Introduction: Clinical trials investigating the safety and efficacy of experimental drugs and devices are the cornerstone of medicinal advancement. Enrolling sufficient participants in these trials is vital to ensure adequate statistical power and generalizability. Clinical trial participation is particularly low among certain populations, including medically underserved communities (i.e., rural areas) and Black, Indigenous, and People of Color (BIPOC). Methods: A retrospective study design was used to understand patient outcomes and access/barriers to clinical trial participation in the rural northwest United States. A quantitatively focused retrospective chart review was conducted for adult participants enrolled in at least one clinical trial in a single northwest health system between 1999 and 2022. Descriptive and inferential statistical analyses were performed to assess trial outcomes at a significance level 0.05. Results: The retrospective chart review yielded 833 clinical trial records with 753 individual enrolled participants. The all-cause relative frequency of death at last known follow-up amongst clinical trial participants was 8.90% (n = 67). Based on logistic regression, the death was significantly associated with the participants' age at initial trial screening (ß = 0.09, p-value <0.001), those that resided in non-metro areas (ß = -0.86, p-value = 0.045), and those that lived in Northeastern Montana (ß = 1.27, p-value = 0.025). Additionally, death at last known follow-up was significantly associated with enrollment in 2021-2022 (ß = -1.52, p-value <0.001), enrolled in more than one study (ß = 0.84, p-value = 0.023), in internationally sponsored trials (ß = -2.08, p-value <0.001), in Phase I (ß = 5.34, p-value <0.001), in Phase II trials (ß = 1.37, p-value = 0.013), diabetes as a primary trial target (ß = -2.04, p-value = 0.003). Conclusion: As decentralized trial design and remote or virtual elements of traditional trials become normative, representation of rural and frontier populations is imperative to support the generalizability of trial data encouraged by the FDA.

Reimagining the joint task force core competency framework for rural and frontier clinical research professionals conducting hybrid and decentralized trials.

Introduction: Clinical research professionals (i.e., clinical research assistants, clinical research nurses, clinical research coordinators, etc.), as outlined by the Joint Task Force (JTF) Core Competency Framework, are highly trained to support the breadth of clinical trial operations and manage participant care. Clinical research professionals are uniquely equipped with a scope of practice that permits product administration, participant assessments, and data management. As clinical trials grow in complexity and their management expands beyond traditional, site-based operations models to decentralized and/or hybrid models, the need becomes great to ensure adequate staffing. However, rural hospitals frequently lack the research staff or patient recruiters that would allow them to support decentralized clinical trials across a sizeable rural geographic demographic. Methods: This paper examines the contributory factors of the clinical research professional workforce contraction and response efforts at professional and organizational levels within a large, Magnet-designated healthcare system in the rural northwestern United States. Perspectives are shared on adapting the Core Competency Framework to reflect the unique strengths and opportunities towards decentralized trials in rural regions of the United States and areas of priority for workforce cultivation and retention. A descriptive survey was used to gather initial data identifying the current research perspectives of healthcare workers working across a rural community. Participants were asked to complete questions about the JTF Competency domains and behavior-based questions. Analysis: Both competency and behavior-based questions were asked and related to roles. These were then cross-referenced using a Rasmussen Ladder system. Descriptive statistics were conducted for sample characteristics, self-reported competency domain questions, and behavior questions. Results and discussion: Survey findings suggest that although healthcare workers and clinical research teams interact, they are unlikely to ask their patients to participate in research. Based on the limited response rate, results suggest that better education throughout the rural community could benefit from decentralized research efforts. Increased use of technology was also highlighted as an area of interest.