TY - JOUR
T1 - Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT)
AU - Gelauff, Jeannette M.
AU - Rosmalen, Judith G. M.
AU - Carson, Alan
AU - Dijk, Joke M.
AU - Ekkel, Martijn
AU - Nielsen, Glenn
AU - Stone, Jon
AU - Tijssen, Marina A. J.
PY - 2020/9/29
Y1 - 2020/9/29
N2 - OBJECTIVE: To determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education. METHODS: In this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care. RESULTS: A total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients. CONCLUSION: We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right. CLINICALTRIALSGOV IDENTIFIER: NCT02589886. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.
AB - OBJECTIVE: To determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education. METHODS: In this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care. RESULTS: A total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients. CONCLUSION: We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right. CLINICALTRIALSGOV IDENTIFIER: NCT02589886. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.
UR - http://www.scopus.com/inward/record.url?scp=85091956840&partnerID=8YFLogxK
U2 - https://doi.org/10.1212/WNL.0000000000010381
DO - https://doi.org/10.1212/WNL.0000000000010381
M3 - Article
C2 - 32690783
SN - 0028-3878
VL - 95
SP - e1883-e1896
JO - Neurology
JF - Neurology
IS - 13
ER -