BACKGROUND
Of the ~1 million persons in the US living with multiple sclerosis (MS), over half receive informal, unpaid care or support from family or friends (caregivers). Despite reports of high levels of stress, anxiety, and negative emotions, only three psycho-educational interventions for these caregivers have been tested. None of these interventions have included web-delivered tailored information combined with tailored coaching with the aim of improving emotional and psychological outcomes for caregivers of persons with MS (PwMS).
OBJECTIVE
Objectives: This paper presents a protocol for a randomized controlled trial that aims to test the efficacy of two interventions for improving stress, anxiety, depression and negative emotions for PwMS.
METHODS
Participants will include any self-identified family/friend caregiver of a PwMS. Data will be collected from April 2021 until November. Participants are randomized to receive either a website-only or a website-coaching intervention which is delivered over a 6 week period. Data are collected online via REDCap at baseline, 6 weeks after baseline (after delivery of intervention) and 6 weeks later.
RESULTS
The protocol was approved by the Case Western Reserve University Institutional Review Board (IRB) on January 21, 2021 (Protocol number 20201484). As of May 2021, we have enrolled 66 participants.
CONCLUSIONS
Our findings will have implications for identifying the efficacy of two types of interventions developed for caregivers of PwMS in reducing negative psychological outcomes associated with caregiving.
CLINICALTRIAL
Trial Registration: Registered with ClinicalTrials.gov, registration number: NCT04662008.