RCT of a Telehealth Group-Based Intervention to Increase Physical Activity in Multiple Sclerosis

Abstract

Objective.Conduct a pilot randomized clinical trial to determine whether participation in a group-based structured telehealth intervention increases physical activity in people with multiple sclerosis (MS).Methods.In this parallel-arms trial, all study procedures were administered remotely. Adults diagnosed with MS (any subtype) were randomized to one of two 12-week (1 hour/week) active conditions: eFIT, online moderated structured groups; or eJournal, online independent journaling. For comparison, treatment as usual (TAU; i.e., no eFIT / eJournal) group was enrolled. Primary outcome was feasibility (completion, adherence). Secondary efficacy outcomes included self-reported physical activity level (International Physical Activity Questionnaire, IPAQ).Results.Participants were 37 adults with MS. Sample was diverse: 66.7% female; age range 23-64 years; 17.5% Hispanic, 12.5% Black; progressive and relapsing-remitting disease subtypes. Regarding feasibility, 70.7% completed; average adherence was 74.9%. Physical activity in active groups increased by 34.2% (baseline IPAQ= 2406.8 ± 1959.7, follow-up= 3229.4 ± 2575.2); decreased in TAU group by 17.4% (baseline=2519.9 ± 1500.1, follow-up=2081.2 ± 1814.9); group x time interaction was not statistically significant [F(2, 25)=1.467, p=.250; partial η2= .105].Conclusionsand relevance. Telehealth represents an accessible, acceptable vehicle to deliver targeted behavioral treatments to a neurological population. eFIT may be an effective intervention for increasing physical activity, a historically intractable treatment target, in individuals with MS. Additionally, these results provide evidence for feasibility of conducting fully remote clinical trial research.Classification of evidence:This study provides Class II evidence that for people with MS, participation in a group-based structured telehealth intervention compared to treatment as usual did not significantly change self-reported physical activity level or the percentage of participants who completed follow-up questionnaires. The trial was registered at ClinicalTrials.gov (NCT03829267).

Feasibility trial of a telehealth support group intervention to reduce anxiety in multiple sclerosis

“…Primary feasibility outcomes were adherence and completion, with efficacy measures identified as secondary outcomes. This design is consistent with prior feasibility trials conducted by our group 18,23 and incorporates feasibility metrics highlighted by other groups in MS. 24…”

“…Primary feasibility outcomes were adherence and completion, with efficacy measures identified as secondary outcomes. This design is consistent with prior feasibility trials conducted by our group 18,23 and incorporates feasibility metrics highlighted by other groups in MS. 24 The primary research questions were: (1) Is a telehealth support group intervention to reduce anxiety in MS feasible? (2) Does participation in a telehealth support group intervention result in decreased anxiety in PwMS?…”

“…The primary preliminary efficacy outcome selected for the study was state anxiety, but depression and loneliness were evaluated as secondary efficacy outcomes based on prior work from our group showing that participation in support group-based telehealth interventions reduces both in pwMS. 23,38 Here, we found a selective effect for state anxiety, but not depression or loneliness. Although the reasons for these findings are unclear and warrant mechanistic investigation, it highlights anxiety and depression as separable mood states requiring targeted treatments.…”

Assessing diagnosis disclosure and concealment in multiple sclerosis: Development and initial validation of the DISCO-MS survey

“…In clinical contexts, 10,11 pwMS frequently describe uncertainty, isolation, stress, and anxiety brought about by DISCO; however, there is a paucity of formal research investigating this issue. Moreover, the field lacks a formal, validated measurement tool assessing DISCO behaviors in individuals with MS. To fill this gap, we developed the DISCO-MS survey, a self-report instrument for research and clinical use assessing (1) diagnosis concealment behaviors and (2) expected consequences of diagnosis disclosure in pwMS.…”

Associations of social network structure with cognition and amygdala volume in multiple sclerosis: An exploratory investigation

“…Targeting individuals with small, close-knit networks holds the promise of a novel approach to managing MS-related impairment of language functions. For instance, participation in group-based telehealth interventions, broadening a person’s network, has shown to positively impact mental and physical health in patients with MS. 36,37 Follow-up studies examining the effects of support groups on MS-related cognitive changes are warranted. Our results also provide a first elucidation of mechanism, given the observed association of social network variables to amygdala volume.…”