Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial

BACKGROUNDOf the approximately 1 million people living with multiple sclerosis in the United States, more than half receive informal, unpaid care or support from family or friends (caregivers). These caregivers report high levels of stress, anxiety, and negative emotions. Few researchers have conducted psychoeducational interventions for these caregivers. OBJECTIVEThis paper presents a protocol for a randomized clinical trial that aims to test the efficacy of two interventions for improving stress, anxiety, depression, and negative emotions for caregivers of persons with multiple sclerosis. METHODSParticipants included any self-identified family or friend caregiver of a person with multiple sclerosis. Data collection began in April 2021 and is expected to continue until November 2021. Participants will be randomized to receive either a website-only or a website-coaching intervention delivered for 6 weeks. Data will be collected at baseline, 6 weeks after baseline (after delivery of intervention), and 6 weeks later. RESULTSThe protocol was approved by the institutional review board of the Case Western Reserve University on January 21, 2021 (protocol 20201484). As of May 2021, 66 participants were enrolled. CONCLUSIONSOur findings will have implications for identifying the efficacy of two types of interventions developed for caregivers of persons with multiple sclerosis to reduce negative psychological outcomes associated with caregiving. TRIAL REGISTRATIONClinicalTrials.gov NCT04662008; http://clinicaltrials.gov/ct2/show/NCT04662008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)DERR1-10.2196/30617.