The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden. Enrolling with a Caregiver is optional for MS participants.
Investigators will compare two groups of MS participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOTCH-MS immediately (Group 1) and another group that will receive HOBSCOTCH-MS (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.
HOBSCOTCH-MS involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. MS participants are asked to do short homework assignments and both MS and Caregiver participants are asked to keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).
After completing the intervention, MS Participants and their Caregivers may also participate in an optional one-time Key Informant Interview for qualitative analysis in an effort to further adapt and improve the HOBSCOTCH-MS in the future.
Inclusion Criteria - MS Participant
Age 20 - 75 years
Diagnosis of relapsing or progressive MS
Education of at least Grade 12 or GED
Exclusion Criteria MS Participant
Current diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder or substance use disorder).
Other neurological disorder such as epilepsy, brain tumor, severe brain injury or mild to moderate brain injury with a history of 30 or more minutes' loss of consciousness, or other disorder that would confound the focus on MS
Diagnosed developmental attention, learning, or intellectual disorder; sensory, motor, or physical disability that would prevent engagement with the intervention or render the person unable complete study outcome measures
Parallel
Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)
BehavioralHOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-MS is an adaptation of the HOBSCOTCH program specifically for people who have multiple sclerosis. It incorporates education about these conditions and cognition into the education module.
Change in quality of life in MS participants as measured by comparing PROMIS-10 Global Health scores at baseline and at 3 months post-intervention.
PROMIS Global-10 Global Health is a validated 10-question survey and part of the Patient-Reported Outcomes Measurement Information System (PROMIS) used to assess health care-related quality of life. Measures include overall health, pain, fatigue, social health, mental health, and physical health. 9 of the items are scored on a Likert Scale of 1 - 5 with 5 representing the best health care-related quality of life; higher scores are associated with better quality of life. One item related to pain is measured on a scale of 1 - 10 with 10 being the worst possible pain.
Change in subjective cognitive function in MS participants as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-intervention.
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention.
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
Changes in MS and Caregiver participants' knowledge of relationship between the condition of MS and cognition and memory as measured by comparing scores on the HOBSCOTCH-MS Knowledge Questionnaire at baseline and at 6 months (end of study).
The MS Knowledge Questionnaire is a 12-item Yes/No (true/false) questionnaire that was developed by the study team at the HOBSCOTCH Institute. It is scored based on number of correct responses.
Change in MS participants quality of life as measured by comparing FAMS-Functional Assessment of Multiple Sclerosis v4.0 scores at base line and at 3 months post-HOBSCOTCH-MS intervention.
The Functional Assessment of Multiple Sclerosis (FAMS) is a validated self-report health-related quality-of-life instrument for people with multiple sclerosis. The FAMS consists of 44 scored (5-point Likert scale) items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional wellbeing (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social wellbeing (seven items). An Additional concerns subscale consists of 15 other items that fall outside of the six domains but may provide valuable information to the clinician. The FAMS includes items across the International Classification of Functioning components of body functions, activities and participation, and environmental factors. Higher scores indicate better quality of life.
Change in MS participants objective cognitive processing speed as measured by comparing Symbol-Digit Modalities Test scores (orally) at base line and at 3 months post-HOBSCOTCH-MS intervention.
The Symbol Digit Modalities Test (SDMT) is a validated tool that objectively measures cognitive processing speed. It requires a person to substitute a number (1 - 9), either orally or written, for randomized presentations of geometric figures over 90 seconds. Scores range between 0 and 100 with a lower score representing poorer performance.
Change in MS participants verbal learning and memory as measured by comparing California Verbal Learning Test-III scores at baseline and 3 months post-HOBSCOTCH-MS intervention
The California Verbal Learning Test-III is an objective, validated verbal learning and memory assessment. It consists of a 16-word, list-recall task with up to five learning/recall trials. Higher scores of recall over time are associated with better performance.
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