HOBSCOTCH-MS-Efficacy Trial
Recruiting · NCT06951919 · Interventional (participants receive a specific treatment) · Lead sponsor: Dartmouth-Hitchcock Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Inclusion Criteria - MS Participant
- Age 20 - 75 years
- Diagnosis of relapsing or progressive MS
- Education of at least Grade 12 or GED
- Fluent in English
- Subjective cognitive and memory challenges
- Internet access
- Telephone access
- Inclusion Criteria - Caregiver Participant
- 20 years +
- Fluent in English
- Caregiver to a MS Participant
- Participant MS has given permission to Caregiver to enroll with them
- Internet access
- Telephone access
Exclusion criteria
- 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
- Exacerbation of MS symptoms (relapse) or ongoing steroid treatment within three months of study enrollment
- Significant visual impairment precluding reading or writing
- Lack of access to the technical resources (e.g., internet access, telephone) required for participation
- Exclusion Criteria - Caregiver Participant
- Significant visual impairment precluding reading or writing
- No reliable telephone or internet access
Where it is running
1 location listed across 1 US state.
- Dartmouth-Health Lebanon - Lebanon, New Hampshire, United States