Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial
Notice bibliographique
Résumé
BACKGROUND: Neurofibromatoses (NF) are rare genetic conditions associated with substantial psychosocial burden and impaired quality of life (QoL). We developed the first NF-tailored mind-body program (the Relaxation Response Resiliency Program for NF) and adapted it for delivery via live videoconferencing to decrease participation barriers and increase its reach. In a pilot randomized controlled trial (RCT), we found that the Relaxation Response Resiliency Program for NF had excellent feasibility and acceptability when delivered via live videoconferencing; furthermore, the Relaxation Response Resiliency Program for NF showed proof of concept in improving QoL compared with an NF-tailored health education control program (the Health Enhancement Program for NF). A fully powered trial is needed to ascertain the efficacy and durability of the Relaxation Response Resiliency Program for NF delivered via secure live videoconferencing among geographically diverse patients. OBJECTIVE: The objective of this study is to evaluate the efficacy of the Relaxation Response Resiliency Program for NF versus the Health Enhancement Program for NF, both delivered in groups via secure live videoconferencing, among geographically diverse patients with NF across the United States and internationally. Here we describe the protocol, manualized treatments, evaluation plan, and study design. METHODS: This is a single-blind RCT. Patients are told that they will be randomized to one of the two stress management programs (stress management program 1: the Relaxation Response Resiliency Program for NF and stress management program 2: the Health Enhancement Program for NF). Patients are recruited from NF-specific national and international foundations and NF clinics across the United States through study ads and a video of participants who have completed the program as part of the pilot study or ongoing trial. Interested participants are screened for eligibility via secure live videoconferencing (self-reported stress and difficulties coping, no change in antidepressant medication within the past 3 months, no psychotherapy within the past 3 months, no major upcoming surgeries within the next 12 months, English speaking, and able to complete questionnaires online and participate in live video interventions) and consent obtained before participation. Both programs are manualized comprising 8 sessions delivered via secure live videoconferencing by trained clinical psychologists. Primary outcomes are physical health QoL and psychological health QoL. Secondary outcomes are social relationship QoL, environment QoL, and psychosocial and resiliency variables. Outcomes are assessed at baseline, posttraining, and 6- and 12-month follow-ups. RESULTS: The trial is ongoing. Thus far, we have recruited 55 patients and aim to recruit a total of 224. Recruitment will close in May 2020; we plan to complete data analyses by June 2021. CONCLUSIONS: This trial will answer key questions about the efficacy and durability of the Relaxation Response Resiliency Program for NF via live videoconferencing with English-speaking adults with NF worldwide. If found efficacious, this program can be readily implemented through national and international NF foundations and NF-specific clinics. The virtual model of delivery has extensive applications for patients in rural areas, those with disability or illness that precludes travel to clinics, and those with rare diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT03406208; https://clinicaltrials.gov/ct2/show/NCT03406208 (Archived by WebCite at http://www.webcitation.org/72ZoTDQ6h). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/11008.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,001 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».