Columbia University Irving Medical Center

Author Of 3 Presentations

Clinical Trials Late Breaking Abstracts

LB1200 - The SUNLIGHT Study: A telehealth intervention to address mental health in persons with MS during COVID-19  (ID 2034)

Speakers
Presentation Number
LB1200
Presentation Topic
Clinical Trials

Abstract

Background

The arrival of the Covid-19 pandemic in the United States brought a heightened level of anxiety to the general population. Individuals with chronic diseases such as multiple sclerosis (MS) were expected to be particularly affected. To address mental health needs safely and immediately, we conducted a trial of a group-based telehealth treatment of professional online support groups to reduce anxiety in persons with MS, the SUNLIGHT study.

Objectives

To determine feasibility and initial efficacy of a pilot trial of online structured, moderated professional support groups to reduce anxiety in persons with MS during the US outbreak of Covid-19. Trial was registered at clinicaltrials.gov (NCT04379661).

Methods

All procedures were conducted remotely. Thirty-two patients with MS were recruited in March-April 2020 at an MS Center in New York City. Consent was obtained via eConsent. 21 received active treatment: 1 hour/week online structured group therapy; 11 served as an inactive control group (i.e., treatment as usual, TAU). Baseline measures were collected from all participants: anxiety (Stait-Trait Anxiety Inventory, primary efficacy outcome), stress (Perceived Stress Scale), distress (Impact of Event Scale), mood (Patient Health Questionnaire), loneliness (UCLA Loneliness Scale), self-efficacy (General Self-Efficacy Scale), quality of life (Functional Assessment of Multiple Sclerosis).

Results

Sample was diverse: 83% female; 23.3% Hispanic / Latino, 10% Black, 3.3% Asian; age range: 24-72 years; disease duration: .25 -38 years. 30% Major Depressive Disorder, 30% anxiety disorder. At baseline, 36.6% had an anxiety attack within past 4 weeks.

Feasibility: Completion and adherence for treatment group were high; 80.9% completed the intervention; average adherence was 75%.

Efficacy results: Anxiety decreased in the treatment group after 12-weeks (STAI mean change = -2.7 points; p=.09).

Qualitative results: 100% responded YES to 'did you find the SUNLIGHT study to be worth your time,' and 'would you recommend SUNLIGHT study to a friend with MS;' 95% responded YES to 'if it were possible to continue your participation in the SUNLIGHT study, would you choose to do so;' 53% responded YES to 'do you think participation in the SUNLIGHT study contributed to a decrease in any of your MS symptoms?'

Conclusions

Telehealth provides an acceptable, accessible, safe vehicle for delivering mental health treatment to chronic disease populations during Covid-19. High adherence and completion, and initial evidence showing reduced anxiety bolster professional support groups as a promising treatment option for individuals with MS. Low cost, high return solutions such as online support groups should be further explored in future large-scale trials. Rigorous clinical trail evidence is needed to elevate the priority given to telehealth behavioral treatments.

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Clinical Outcome Measures Poster Presentation

P0165 - Social Matters: Social support is linked to mental health, quality of life, and motor function in multiple sclerosis (ID 1219)

Speakers
Presentation Number
P0165
Presentation Topic
Clinical Outcome Measures

Abstract

Background

We are social animals who naturally seek the companionship of others as an essential part of our physical and psychological well-being. Patients with multiple sclerosis (MS) who are dealing with a chronic and often debilitating disease are at higher risk for social isolation, which may be particularly detrimental to their health.

Objectives

We investigated associations of social support with mental health, cognition, and motor functioning in cross-sectional data from two independent cohorts of patients with MS. We further explored sex differences in these relationships, based on a bioevolutionary theoretical justification.

Methods

Social support was assessed in 185 recently diagnosed patients (RADIEMS cohort), and in an independent validation sample (MEM CONNECT cohort, n = 62). Patients also completed a comprehensive neurobehavioral evaluation including measures of mental health, fatigue, quality of life, cognition and motor function. Correlations tested links between social support and these variables, along with potential gender differences.

Results

In both samples, higher social support was associated with better mental health, quality of life, subjective cognitive function, and less fatigue. In the RADIEMS cohort, correlations showed positive associations between social support and motor functions. The most robust relationships were observed for gross motor functions (gait, grip strength), especially in women.

Conclusions

These findings highlight associations of social support to overall psychological health and motor functioning in persons with MS, underlining the potential opportunity of evaluating and promoting social engagement as a novel treatment strategy.

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Clinical Trials Poster Presentation

P0190 - ASPIRE Study: Protocol for a double-blind RCT of aspirin for overheating during exercise in MS (ID 666)

Speakers
Presentation Number
P0190
Presentation Topic
Clinical Trials

Abstract

Background

Background Exercise holds many benefits for persons with multiple sclerosis (MS), yet many MS patients are heat sensitive and therefore avoid exercise due to overheating and exhaustion that result. The exercise literature in MS to date is likely subject to bias by predominant representation of patients who are not heat sensitive and may not be a representative sample. Finding ways to facilitate comfortable engagement in exercise for persons with MS is a key priority. Our pilot trial of aspirin as a cooling pretreatment for exercise in MS showed favorable results: after aspirin, participants who experience overheating during exercise were able to exercise longer and the amount of body temperature increase they experienced was reduced by 56%.

Objectives

Objective Conduct a large-scale double-blind randomized controlled trial of aspirin (acetylsalicylic acid, ASA) pretreatment as a convenient and inexpensive method to prevent overheating and improve exercise performance in persons with MS, compared to placebo and acetaminophen.

Methods

Methods Participants are seen for three separate sessions (separated by at least one week) for a laboratory maximal exercise test. At each session, body temperature is measured tympanically before oral administration of a standard adult dose (650 mg) of aspirin, acetaminophen (APAP), or placebo. Participants then perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (TTE, i.e., time spent cycling to peak exertion) and (b) body temperature change. Secondary outcomes include patient reported outcomes including pain, fatigue, and mood. Cross-over analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.

Results

Results Enrollment in the ASPIRE trial was begun in February 2019. Adherence and acceptability of the treatment are high. To date, 35 participants have been enrolled; of these, 16 have completed all 3 study visits. There have been 6 drop-outs and 7 non-serious adverse events. Heterogeneity of sample is notable, with 26% men, 9% Black, 6% Hispanic/Latinx. Study data will not be unblinded until completion of all participants (target N=60).

Conclusions

Conclusions Exercise is highly beneficial for persons with MS, but only if they do it. Positive findings from this trial would yield an effective, inexpensive, readily available, unobtrusive treatment to allow many more persons with MS access to the benefits of exercise via a cooling mechanism. Thus far, enrollment and adherence in the ASPIRE trial, as well as diversity of our sample suggest good acceptibiliity of aspirin as a treatment, and favorable generalizability of trial results.

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Presenter Of 1 Presentation

Clinical Outcome Measures Poster Presentation

P0165 - Social Matters: Social support is linked to mental health, quality of life, and motor function in multiple sclerosis (ID 1219)

Speakers
Presentation Number
P0165
Presentation Topic
Clinical Outcome Measures

Abstract

Background

We are social animals who naturally seek the companionship of others as an essential part of our physical and psychological well-being. Patients with multiple sclerosis (MS) who are dealing with a chronic and often debilitating disease are at higher risk for social isolation, which may be particularly detrimental to their health.

Objectives

We investigated associations of social support with mental health, cognition, and motor functioning in cross-sectional data from two independent cohorts of patients with MS. We further explored sex differences in these relationships, based on a bioevolutionary theoretical justification.

Methods

Social support was assessed in 185 recently diagnosed patients (RADIEMS cohort), and in an independent validation sample (MEM CONNECT cohort, n = 62). Patients also completed a comprehensive neurobehavioral evaluation including measures of mental health, fatigue, quality of life, cognition and motor function. Correlations tested links between social support and these variables, along with potential gender differences.

Results

In both samples, higher social support was associated with better mental health, quality of life, subjective cognitive function, and less fatigue. In the RADIEMS cohort, correlations showed positive associations between social support and motor functions. The most robust relationships were observed for gross motor functions (gait, grip strength), especially in women.

Conclusions

These findings highlight associations of social support to overall psychological health and motor functioning in persons with MS, underlining the potential opportunity of evaluating and promoting social engagement as a novel treatment strategy.

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