Series of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trials

Butler, Mark J.; D’Angelo, Stefani; Lewis, Courtney; Miller, Danielle; Perrin, Alexandra; Suls, Jerry; Chandereng, Thevaa; Cheung, Ying Kuen; Davidson, Karina W.

doi:10.1136/bmjopen-2021-055518

Cited by 8 publications

(14 citation statements)

References 43 publications

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“…Widespread use of personalized N-of-1 designs has been hampered by difficulties in the feasibility of creating them, with many researchers and clinicians feeling that personalized N-of-1 trials are not the worth the effort needed to conduct them [62]. In assessing the feasibility and acceptability of our developing personalized N-of-1 platform, which has been previously implemented to treat chronic lower back pain [47] and fatigue [46], we hope to continue refining a programmatic template for using personalized N-of-1 designs for other health conditions and other interventions. Further, we hope the use of digital enrollment, consent, intervention delivery, and outcome assessment will make personalized N-of-1 trials more feasible in research and clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…Adherence will be evaluated using the Fitbit tracker and survey completion. Participants wearing the Fitbit for 12 or more hours per day, including at least 180 minutes of sleep time, will be defined as adherent [46,47]. During the 14 days of the baseline period, participants who do not achieve a minimum of 80% adherence to Fitbit tracker wear and study measures (including EMA and survey measures) will be withdrawn from the study before randomization.…”

Section: Adherencementioning

confidence: 99%

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A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler¹,

D’Angelo²,

Perrin³

et al. 2023

JMIR Res Protoc

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Background Poor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions. Objective This trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep. Methods Participants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants’ ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants’ self-reported sleep quality and duration and Fitbit tracker–measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection. Results As of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023. Conclusions Evaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research—is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board. Trial Registration ClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188 International Registered Report Identifier (IRRID) DERR1-10.2196/45313

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Section: Discussionmentioning

confidence: 99%

Section: Adherencementioning

confidence: 99%

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Butler¹,

D’Angelo²,

Perrin³

et al. 2023

JMIR Res Protoc

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“…Personalized trials are becoming more commonplace with recent examples including studying fatigue, depression, and back pain. [21][22][23] The objective of this study was to assess the feasibility and acceptability of a randomized personalized trial that serially delivered four BCTs, one for each 2-week period, to promote low-intensity PA (walking) in middle-aged and older adults. Wearable technology and smartphone messaging were employed to facilitate completely remote delivery of the study.…”

Section: Introductionmentioning

confidence: 99%

“…Personalized trials are becoming more commonplace with recent examples including studying fatigue, depression, and back pain. 21 – 23 …”

Section: Introductionmentioning

confidence: 99%

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

Friel,

Goodwin,

Robles

et al. 2023

Preprint

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Purpose To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults. Design This study used a Personalized (N-of-1) trial design. Setting This study took place at a major healthcare system from November 2021 to February 2022. Subjects Sixty adults (45–75 years, 92% female, 80% white) were recruited. Intervention A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order. Measures Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials. Results Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased. Conclusions Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results.

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“…This study evaluated the feasibility, acceptability, and effectiveness of a series of personalized interventions for virtual delivery of BL therapy, dim light (DL) therapy, and usual care (UC) treatment for fatigue symptoms among 60 participants. By using new wearable technologies (such as Fitbit devices [Fitbit Inc]) and commercially available light therapy devices (such as the AYO wearable device), this study allowed for continuous data collection and virtually conducted assessment [ 28 ]. Furthermore, virtual delivery of the intervention allowed each participant to receive treatment and be assessed for fatigue in their own home.…”

Section: Introductionmentioning

confidence: 99%

A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment

Butler,

D’Angelo,

Ahn

et al. 2023

JMIR Form Res

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Background Fatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown. Objective This study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants. Methods Participants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants. Results Participants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=−1.63, 95% CI −2.63 to −0.63) and DL (B=−1.44, 95% CI −2.50 to −0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms. Conclusions The participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials. Trial Registration ClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846

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Series of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trials

Cited by 8 publications

References 43 publications

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials

Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults’ Physical Activity

A Series of Personalized Virtual Light Therapy Interventions for Fatigue: Feasibility Randomized Crossover Trial for N-of-1 Treatment

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