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HOBSCOTCH-MS-Efficacy Trial

NCT06951919 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-10-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Elaine T Kiriakopoulos · Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951919 on ClinicalTrials.gov