Actively Recruiting

Phase Not Applicable
Age: 20Years - 75Years
All Genders
NCT06951919

HOBSCOTCH-MS-Efficacy Trial

Led by Dartmouth-Hitchcock Medical Center · Updated on 2025-10-29

125

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

HOBSCOTCH-MS-Efficacy Trial

Who Can Participate

Age: 20Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • MS Participants aged 20 to 75 years
  • Diagnosis of relapsing or progressive multiple sclerosis
  • Education level of at least Grade 12 or GED
  • Fluent in English
  • Experience subjective cognitive and memory challenges
  • Have internet access
  • Have telephone access
  • Caregiver participants aged 20 years or older
  • Caregivers fluent in English
  • Caregivers must be caring for an enrolled MS participant with the participant's permission
  • Caregivers have internet and telephone access
Not Eligible

You will not qualify if you...

  • MS Participants with current diagnosed psychiatric disorders such as schizophrenia, bipolar disorder, or substance use disorder
  • Presence of other neurological disorders like epilepsy, brain tumor, or brain injury with significant loss of consciousness
  • Diagnosed developmental attention, learning, or intellectual disorders
  • Sensory, motor, or physical disabilities preventing participation or completion of study measures
  • MS relapse or steroid treatment within three months before enrollment
  • Significant visual impairment preventing reading or writing
  • Lack of reliable internet or telephone access
  • Caregivers with significant visual impairment preventing reading or writing
  • Caregivers without reliable telephone or internet access

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dartmouth-Health Lebanon

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

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Research Team

M

Meredith E Olenec

CONTACT

S

Sarah J Kaden

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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