دورية أكاديمية
Feasibility and acceptability for LION, a fully remote, randomized clinical trial within the VA for light therapy to improve sleep in Veterans with and without TBI: An MTBI 2 sponsored protocol: LION: A remote RCT protocol within VA.
| العنوان: | Feasibility and acceptability for LION, a fully remote, randomized clinical trial within the VA for light therapy to improve sleep in Veterans with and without TBI: An MTBI 2 sponsored protocol: LION: A remote RCT protocol within VA. |
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| المؤلفون: | Elliott JE; VA Portland Health Care System, Portland, OR, USA.; Oregon Health & Science University, Department of Neurology, Portland, OR, USA.; Military Traumatic Brain Injury Initiative (MTBI), Bethesda, MD, USA.; VISN 20 Northwest Mental Illness Research, Education and Clinical Center (MIRECC), VA Puget Sound Health Care System, Seattle, WA, USA., Brewer JS; VA Portland Health Care System, Portland, OR, USA., Keil AT; VA Portland Health Care System, Portland, OR, USA., Ligman BR; VA Portland Health Care System, Portland, OR, USA., Bryant-Ekstrand MD; VA Portland Health Care System, Portland, OR, USA., McBride AA; VA Portland Health Care System, Portland, OR, USA., Powers K; VA Portland Health Care System, Portland, OR, USA., Sicard SJ; VA Portland Health Care System, Portland, OR, USA., Twamley EW; VA San Diego Health Care System, Research Service; Center of Excellence for Stress and Mental Health, San Diego, CA, USA.; University of California San Diego, Department of Psychiatry, La Jolla, CA, USA., O'Neil ME; VA Portland Health Care System, Portland, OR, USA.; VISN 20 Northwest Mental Illness Research, Education and Clinical Center (MIRECC), VA Puget Sound Health Care System, Seattle, WA, USA.; Oregon Health & Science University, Medical Informatics and Clinical Epidemiology, Portland, OR, USA.; Oregon Health & Science University, Department of Psychiatry, Portland, OR, USA., Hildebrand AD; Oregon Health & Science University - Portland State University, School of Public Health, Biostatistics & Design Program, Portland, OR, USA., Nguyen T; Oregon Health & Science University - Portland State University, School of Public Health, Biostatistics & Design Program, Portland, OR, USA., Morasco BJ; VA Portland Health Care System, Portland, OR, USA.; VISN 20 Northwest Mental Illness Research, Education and Clinical Center (MIRECC), VA Puget Sound Health Care System, Seattle, WA, USA.; Oregon Health & Science University, Department of Psychiatry, Portland, OR, USA., Gill JM; John's Hopkins University, School of Nursing, Baltimore, MD, USA., Dengler BA; Military Traumatic Brain Injury Initiative (MTBI), Bethesda, MD, USA., Lim MM; VA Portland Health Care System, Portland, OR, USA.; Oregon Health & Science University, Department of Neurology, Portland, OR, USA.; Military Traumatic Brain Injury Initiative (MTBI), Bethesda, MD, USA.; VISN 20 Northwest Mental Illness Research, Education and Clinical Center (MIRECC), VA Puget Sound Health Care System, Seattle, WA, USA. |
| المصدر: | MedRxiv : the preprint server for health sciences [medRxiv] 2024 May 31. Date of Electronic Publication: 2024 May 31. |
| نوع المنشور: | Journal Article; Preprint |
| اللغة: | English |
| بيانات الدورية: | Country of Publication: United States NLM ID: 101767986 Publication Model: Electronic Cited Medium: Internet NLM ISO Abbreviation: medRxiv Subsets: PubMed not MEDLINE |
| مستخلص: | Sleep-wake disturbances frequently present in Veterans with mild traumatic brain injury (mTBI). These TBI-related sleep impairments confer significant burden and commonly exacerbate other functional impairments. Therapies to improve sleep following mTBI are limited and studies in Veterans are even more scarce. In our previous pilot work, morning bright light therapy (MBLT) was found to be a feasible behavioral sleep intervention in Veterans with a history of mTBI; however, this was single-arm, open-label, and non-randomized, and therefore was not intended to establish efficacy. The present study, LION (light vs ion therapy) extends this preliminary work as a fully powered, sham-controlled, participant-masked randomized controlled trial (NCT03968874), implemented as fully remote within the VA (target n=120 complete). Randomization at 2:1 allocation ratio to: 1) active: MBLT (n=80), and 2) sham: deactivated negative ion generator (n=40); each with identical engagement parameters (60-min duration; within 2-hrs of waking; daily over 28-day duration). Participant masking via deception balanced expectancy assumptions across arms. Outcome measures were assessed following a 14-day baseline (pre-intervention), following 28-days of device engagement (post-intervention), and 28-days after the post-intervention assessment (follow-up). Primary outcomes were sleep measures, including continuous wrist-based actigraphy, self-report, and daily sleep dairy entries. Secondary/exploratory outcomes included cognition, mood, quality of life, circadian rhythm via dim light melatonin onset, and biofluid-based biomarkers. Participant drop out occurred in <10% of those enrolled, incomplete/missing data was present in <15% of key outcome variables, and overall fidelity adherence to the intervention was >85%, collectively establishing feasibility and acceptability for MBLT in Veterans with mTBI. |
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| معلومات مُعتمدة: | IK2 RX002762 United States RX RRD VA; IK2 RX002947 United States RX RRD VA; IK6 RX003504 United States RX RRD VA; T32 AT002688 United States AT NCCIH NIH HHS |
| فهرسة مساهمة: | Keywords: Morning bright light therapy; TBI; VA; Veterans; actigraphy; feasibility; light box; randomized controlled trial; remote study; sleep |
| تواريخ الأحداث: | Date Created: 20240610 Latest Revision: 20240613 |
| رمز التحديث: | 20240613 |
| مُعرف محوري في PubMed: | PMC11160858 |
| DOI: | 10.1101/2024.05.30.24308195 |
| PMID: | 38853958 |
| قاعدة البيانات: | MEDLINE |
| DOI: | 10.1101/2024.05.30.24308195 |
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