Recruiting

HOBSCOTCH-MSHOBSCOTCH-MS-Efficacy Trial

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06951919

Conditions

Multiple Sclerosis

Cognitive Dysfunction

Memory Disorders

Memory Impairment

Memory Dysfunction

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Cognitive Dysfunction

Memory Disorders

Memory Impairment

Memory Dysfunction

Study ID

NCT06951919

Start date

Sep 9, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)

HOBSCOTCH 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.

Primary outcome measure

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. [ Time Frame: Baseline and 3 months post-intervention ]
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. [ Time Frame: Baseline and 3 months post-intervention ]
Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]

Central Contacts and Locations

Central contacts

Meredith E Olenec

603-650-4225 HOBSCOTCH-MS.Research@Hitchcock.org

Sarah J Kaden

603-650-4225 HOBSCOTCH-MS.Research@Hitchcock.org

Locations

Dartmouth-Health Lebanon

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Meredith E Olenec

6036504225 HOBSCOTCH-MS.Research@Hitchcock.org

Sarah J. Kaden, BA

6036504225 HOBSCOTCH-MS.Research@Hitchcock.org

Principal Investigator:

Elaine T. Kirikapoulos, MD, MPH, MSc

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Oct 29, 2025

Last verified

Sep, 2025

Keywords

Cognition
Self-Management
Cognitive Remediation
Cognitive Training
Memory Disorders
Caregivers
Caregiver Burden
Mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2025-10-29.