Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial

Vranceanu, Ana‐Maria; Zale, Emily L.; Macklin, Eric A.; McCurley, Jessica L.; Park, Elyse R.; Jordan, Justin; Lin, Ann; Plotkin, Scott R.

doi:10.2196/11008

Cited by 35 publications

(49 citation statements)

References 42 publications

(48 reference statements)

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“…The principal investigator, a licensed clinical health psychologist with expertise in older adults, mind-body interventions, CP, and CD, reviews all cases before enrollment to confirm eligibility. We have successfully used this strategy in prior intervention development trials conducted remotely [ 39 , 40 ].…”

Section: Methodsmentioning

confidence: 99%

“…We use live video (Zoom) for all study procedures, including assessments and intervention delivery. We developed the live video procedures using our experience in delivering virtual mind-body programs in prior studies [ 39 , 52 , 53 ] and consultations with the Society of Behavioral Medicine Behavioral Informatics Special Interest Group. The research assistant sends download instructions to participants who are unfamiliar with Zoom and offers individualized technical support as needed.…”

Section: Methodsmentioning

confidence: 99%

“…Both treatment arms are delivered by trained clinicians under the direct supervision of health psychologists with expertise in mind-body and walking interventions, geropsychology, and CP. We follow the National Institutes of Health recommendations [ 60 ] and our previously developed clinical adherence protocol to assess treatment fidelity of both programs [ 39 ]. The clinicians complete fidelity checklists after each session and undergo weekly supervision to reinforce protocol adherence.…”

Section: Methodsmentioning

confidence: 99%

“…Participants receive lifestyle education consistent with public health recommendations and standards for health promotion (eg, physical activity, sleep, nutrition, healthy weight, and medical appointments). The program has been successfully used as an active control in multiple prior studies [ 33 , 39 , 40 ]. We adapted the HEP to include population-specific information on CP and CD symptoms.…”

Section: Methodsmentioning

confidence: 99%

“…Table 2 contains the a priori set benchmarks and criteria that align with our prior in-person trial [ 29 ] and similar feasibility pilot studies [ 35 , 39 , 61 ]. We will assess the feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction of both programs delivered virtually.…”

Section: Methodsmentioning

confidence: 99%

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Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

et al. 2021

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Background Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple d...

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

et al. 2021

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Effect of Mind-Body Skills Training on Quality of Life for Geographically Diverse Adults With Neurofibromatosis

et al. 2023

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ImportanceNeurofibromatoses (NF; NF1, NF2, and schwannomatosis) are hereditary tumor predisposition syndromes with a risk for poor quality of life (QOL) and no evidence-based treatments.ObjectiveTo compare a mind-body skills training program, the Relaxation Response Resiliency Program for NF (3RP-NF), with a health education program (Health Enhancement Program for NF; HEP-NF) for improvement of quality of life among adults with NF.Design, Setting, and ParticipantsThis single-blind, remote randomized clinical trial randomly assigned 228 English-speaking adults with NF from around the world on a 1:1 basis, stratified by NF type, between October 1, 2017, and January 31, 2021, with the last follow-up February 28, 2022.InterventionsEight 90-minute group virtual sessions of 3RP-NF or HEP-NF.Main Outcomes and MeasuresOutcomes were collected at baseline, after treatment, and at 6-month and 1-year follow-up. The primary outcomes were physical health and psychological domain scores of the World Health Organization Quality of Life Brief Version (WHOQOL-BREF). Secondary outcomes were the social relationships and environment domain scores of the WHOQOL-BREF. Scores are reported as transformed domain scores (range, 0-100, with higher scores indicating higher QOL). Analysis was performed on an intention-to-treat basis.ResultsOf 371 participants who underwent screening, 228 were randomized (mean [SD] age, 42.7 [14.5] years; 170 women [75%]), and 217 attended 6 or more of 8 sessions and provided posttest data. Participants in both programs improved from baseline to after treatment in primary outcomes of physical health QOL score (3RP-NF, 5.1; 95% CI, 3.2-7.0; P &lt; .001; HEP-NF, 6.4; 95% CI, 4.6-8.3; P &lt; .001) and psychological QOL score (3RP-NF, 8.5; 95% CI, 6.4-10.7; P &lt; .001; HEP-NF, 9.2; 95% CI, 7.1-11.2; P &lt; .001). Participants in the 3RP-NF group showed sustained improvements after treatment to 12 months; posttreatment improvements for the HEP-NF group diminished (between-group difference for physical health QOL score, 4.9; 95% CI, 2.1-7.7; P = .001; effect size [ES] = 0.3; and psychological QOL score, 3.7; 95% CI, 0.2-7.6; P = .06; ES = 0.2). Results were similar for secondary outcomes of social relationships and environmental QOL. There were significant between-group differences from baseline to 12 months in favor of the 3RP-NF for physical health QOL score (3.6; 95% CI, 0.5-6.6; P = .02; ES = 0.2), social relationships QOL score (6.9; 95% CI, 1.2-12.7; P = .02; ES = 0.3), and environmental QOL score (3.5; 95% CI, 0.4-6.5; P = .02; ES = 0.2).Conclusions and RelevanceIn this randomized clinical trial of 3RP-NF vs HEP-NF, benefits from 3RP-NF and HEP-NF were comparable after treatment, but at 12 months from baseline, 3RP-NF was superior to HEP-NF on all primary and secondary outcomes. Results support the implementation of 3RP-NF in routine care.Trial RegistrationClinicalTrials.gov Identifier: NCT03406208

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The impact of a virtual mind–body program on symptoms of depression and anxiety among international English‐speaking adults with neurofibromatosis

McDermott,

Bakhshaie,

Brewer

et al. 2024

American J of Med Genetics Pt A

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The neurofibromatoses (NFs) are a set of incurable genetic disorders that predispose individuals to nervous system tumors. Although many patients experience anxiety and depression, there is little research on psychosocial interventions in this population. The present study examined the effects of a mind–body intervention on depression and anxiety in adults with NF. This is a secondary analysis of the Relaxation Response Resiliency Program for NF (3RP‐NF), an 8‐week virtual group intervention that teaches mind–body skills (e.g., relaxation, mindfulness) to improve quality of life. Participants were randomized to 3RP‐NF or the Health Enhancement Program for NF (HEP‐NF) consisting of health informational sessions and discussion. We evaluated depression (PHQ‐9) and anxiety (GAD‐7) at posttreatment, 6 months, and 12 months. Both groups improved in depression and anxiety between baseline and posttest, 6 months, and 12 months. The 3RP‐NF group showed greater improvements in depression scores from baseline to 6 months compared with HEP‐NF and with lower rates of clinically significant depressive symptoms. There were no between‐group differences for anxiety. Both interventions reduced distress and anxiety symptoms for individuals with NF. The 3RP‐NF group may be better at sustaining these improvements. Given the rare nature of NF, group connection may facilitate reduced distress.

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Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial

Cited by 35 publications

References 42 publications

Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study

Effect of Mind-Body Skills Training on Quality of Life for Geographically Diverse Adults With Neurofibromatosis

The impact of a virtual mind–body program on symptoms of depression and anxiety among international English‐speaking adults with neurofibromatosis

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