HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
New Hampshire
Dartmouth-Health Lebanon
RECRUITING
Lebanon
Contact Information
Primary
Meredith E Olenec
HOBSCOTCH-MS.Research@Hitchcock.org
603-650-4225
Backup
Sarah J Kaden
HOBSCOTCH-MS.Research@Hitchcock.org
603-650-4225
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2028-12
Participants
Target number of participants: 125
Treatments
Experimental: MS Participant Group 1
MS Participant Group 1 will receive the HOBSCOTCH-MS intervention consisting of 1:1 sessions delivered once per week including:~* 1 pre-HOBSCOTCH~* Session (on webcam)~* 1 educational session (on webcam)~* 6 telephone sessions~* 1 wrap-up session (webcam or telephone)
Active_comparator: MS Participant Group 2
MS Participant Group 2 will be on a 3-month wait list after which they will receive HOBSCOTCH-MS consisting of 1:1 sessions delivered once per week including:~* 1 pre-HOBSCOTCH~* Session (on webcam)~* 1 educational session (on webcam)~* 6 telephone sessions~* 1 wrap-up session (webcam or telephone)
Experimental: MS Caregiver Group 1
Caregiver Group 1 will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS participant as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.
Active_comparator: MS Caregiver Group 2
Caregiver Group 2 will be on a 3 month wait list with their MS participant after which time they will receive an adapted version of HOBSCOTCH-MS by attending the introductory session and session 1 of the HOBSCOTCH-MS (virtual) program with their MS patient as well as guidance and instructions on utilizing quick relaxation. Caregiver Group 1 will also attend session 8 of the program with the MS patient to focus on program wrap-up and maintenance planning.
Related Therapeutic Areas
Sponsors
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov