Pilot of the Virtual Memory Attention and Problem Solving Skills Intervention for Persons With Multiple Sclerosis (MS)

NCT06709768 | Not Yet Recruiting

• 1 other identifier: STUDY000066747
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot clinical trial is to study is to test the feasibility and effects of a virtual (remote) version of a cognitive rehabilitation intervention - Memory, Attention, and Problem Solving Skills for Persons with MS (MAPSS-MS). We have already tested this intervention "in person" and found it to be effective at helping persons with MS improve their cognitive function learn. We are now testing the MAPSS-MS intervention using a virtual or remote format. The main questions this pilot study aims to answer are:

1. 1.What is the feasibility of the Virtual MAPSS-MS intervention
2. 2.Compared with persons in the wait list control group, will persons receiving the Virtual MAPSS-MS intervention have better overall neurocognitive function and 3. ) Compared with persons in the wait list control group, will persons receiving the Virtual MAPSS-MS intervention have improved stress, self-efficacy for cognitive everyday tasks, use of compensatory strategies and improved depressive symptoms, fatigue, sleep and pain.

Conditions

Multiple Sclerosis (MS)

Keywords

cognitive rehabilitation

Outcome Measures

Primary Outcomes (2)

• Neurocognitive Function -Objective

  The Neurocognitive Index (NCI) score will be obtained via remote administration of the CNS Vital Sign's (CNS Vital Signs, LLC) Core computerized neurocognitive test battery. Batteries will be administered on participant's own computers. The core battery includes seven tests for verbal and visual memory, reaction time, processing speed, executive function, simple attention and motor speed, and five domain scores for composite memory, psychomotor speed, reaction time, cognitive flexibility, and complex attention The Neurocognitive Index is the average of five domain scores, representing a global score of neurocognition.

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

• Perceived Cognitive Function PROMIS v2.0 - Cognitive Function-Abilities Short Form 8a

  The PROMIS v2.0 - Cognitive Function-Abilities Short Form 8a includes 8 items that assess patient-perceived cognitive deficits including the areas of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency.

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

Secondary Outcomes (7)

• Self-Efficacy for Cognitive Tasks

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

• Depressive Symptoms - CES-D 10

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

• Compensatory Strategies

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

• Perceived Stress

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

• Pain Symptoms

  This measure will be completed at baseline, following the 8 week intervention and 6 weeks after the intervention is complete.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Individuals randomized to the intervention group will receive the MAPSS-MS virtually over an 8 week time period. The Virtual MAPSS-MS has two components: (1) group sessions via Microsoft teams with an expert facilitator focused on providing information and building efficacy for use of cognitive strategies, and (2) computer assisted cognitive training (Brain HQ).

Behavioral: Virtual Memory, Attention, and Problem Solving Skills for Persons with MS (MAPSS-MS)

Wait List Control

NO INTERVENTION

Participants in this arm will complete data collection at the same time and intervals as the experimental arm. When all three data collections have been completed, they will be offered the opportunity to participate in the intervention - no additional data will be collected following the intervention.

Interventions

Virtual Memory, Attention, and Problem Solving Skills for Persons with MS (MAPSS-MS) BEHAVIORAL

This is a pilot test of the MAPSS-MS intervention in a virtual delivery format.

Intervention Group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Alexa Stuifbergen, PhD

CONTACT

512-232-4764; astuifbergen@mail.nur.utexas.edu

Heather Becker, PhD

CONTACT

512-471-9097; hbecker@mail.nur.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available from January 2026 to December 2028
• Access Criteria: Individuals with PI status at other educational or research institutions may contact the study PI regarding data sharing. Specific plans will be developed in conjunction with the IRB that has study oversight.