Improving Prospective Memory Via Telehealth

NCT05129293 | Completed Results

• 1 other identifier: MSH 21-63
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial. The study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments.

Conditions

Multiple Sclerosis

Keywords

prospective memory; cognitive dysfunction; multiple sclerosis

Outcome Measures

Primary Outcomes (2)

• Memory for Intentions Test Total Score Percentile

  Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \<1 9 (coded as 0 for analyses) to \>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.

  Six weeks

• Memory for Intentions Test Time Cue Subscale Percentile

  Performance on objective prospective memory (time-based)

  Six weeks

Secondary Outcomes (1)

• Perceived Deficits Questionnaire-Prospective Memory Subscale

  Six weeks

Study Arms (2)

Prospective Memory Intervention

EXPERIMENTAL

Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.

Behavioral: Prospective Memory Intervention

Educational

ACTIVE COMPARATOR

The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.

Behavioral: Educational

Interventions

Prospective Memory Intervention BEHAVIORAL

Cognitive remediation focusing on prospective memory

Prospective Memory Intervention

Educational BEHAVIORAL

Psychoeducation

Educational

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of MS
• Able to read, write, and speak in English
• Between the ages of 18 and 60
• All genders
• No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse
• No relapses within the past two months
• Access to the Internet and a web camera
• Not enrolled in a cognitive rehabilitation program within the past six months
• Self-reported issues "remembering places they have to be" and "things they have to do"

You may not qualify if:

• No diagnosis of MS
• Unable to complete the study protocol due to language barriers
• Younger than 18 or older than 61
• History of other serious neurologic or psychiatric illness, including drug or alcohol misuse
• Had a relapse within the past two months
• No access to the Internet and/or a web camera
• Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months
• No self-reported issues with "remembering places they have to be" or "things they have to do"

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (1)

Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Mandell Center Research Team
• Organization: Trinity Health Of New England

MSResearch@TrinityHealthOfNE.org

860-714-3005

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: November 1, 2021
• Primary Completion: June 5, 2023
• Study Completion: June 30, 2023
• Last Updated: October 18, 2024
• Results First Posted: October 18, 2024

Record last verified: 2024-10

Locations

US (1)