Resilient Together-ALS (RT-ALS): A dyadic mind-body meaning intervention for people with ALS and their informal care-partners - PROJECT SUMMARY Background: Approximately 31,000 patients in the United States and 500,000 people worldwide are living with Amyotrophic Lateral Sclerosis (ALS), an uncurable, progressive neurodegenerative disease (NDD) that affects spinal cord and brain nerve cells leading to loss of motor control, difficulty swallowing, paralyses, respiratory failure, and death within 3-5 years. Half of patients with ALS experience clinically significant emotional distress at diagnosis and patient and care-partner distress are strongly related (i.e., dyad); if untreated, this early distress can become chronic. No routine treatment exists for addressing emotional distress in ALS dyads early after diagnosis. Specific Aims and Design: My K23 aims to develop, refine, and pilot a mind-body meaning intervention to prevent chronic emotional distress: “Resilient Together ALS (RT-ALS).” My aims are guided by the NCCIH Research Framework. Aim 1: Develop RT-ALS. I will conduct 1) qualitative semi-structured interviews (about 20 dyads or until saturation) to gather feedback on intervention content and delivery preferences; and 2) focus groups (3-4; about 20 staff total until saturation) with interdisciplinary ALS providers to gather feedback on session content and barriers and facilitators to recruitment. Aim 2: Optimize RT-ALS. I will explore initial feasibility and acceptability of RT-ALS via a single-arm open pilot (N=10 dyads) with exit interviews and pre-post assessments. Aim 3: Test the feasibility and acceptability of the refined RT-ALS intervention. I will conduct a pilot feasibility randomized clinical trial (RCT) of RT-ALS vs. minimally enhanced usual care (MEUC; educational pamphlet) (N=50 dyads). Findings from this K23 proposal will inform a multisite feasibility R01 trial followed by a multisite efficacy trial using the UH3/UG3 mechanism and subsequent implementation and dissemination (NCCIH Research Framework). Training and Mentoring: To pursue the proposed research, I have 3 training aims: 1) Qualitative methods for intervention development and optimization; 2) Mixed methods for intervention development and optimization; and 3) Dyadic mind-body meaning RCT methodology. This research and my training will be supported by my exceptional mentoring team with expertise in mind-body dyadic intervention development (Vranceanu), spirituality and meaning (Park), ALS (Lindenberger, Brizzi), and statistics (Parker). Further, I have access to a rich institutional environment as well as coursework, scientific meetings, trainings, and planned publications tailored to training aims and the proposed research. Relevance to NCCIH: The proposed research aligns with the NCCIH Strategic Plan FY 2021– 2025 Objective 2: Advance research on the whole person and on the integration of complementary and conventnioal care; and Objective 3: Foster research on health promotion and restoration, resilience, disease prevention, and symptom management. Impact: My goal is to become a clinical investigator who builds dyadic mind-body meaning interventions in ALS/NDDs. If funded, the K23 would support the training, mentorship, partnerships, and research experience I need to transition to independence. If successful, findings from this K23 proposal will inform a multisite feasibility R01 trial followed by a multisite efficacy trial using the UH3/UG3 mechanism and subsequent implementation and dissemination (NCCIH Research Framework). The proposed research has the potential to reduce suffering and disease burden for patients with ALS, their care-partners, and the healthcare system. Future work could explore dissemination and implementation in settings nationally and worldwide adapted to a range of serious illnesses and local cultural context.
