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Completed

NCT Number: NCT05129293

Improving Prospective Memory Via Telehealth

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Rehabilitation Hospital

Hartford, Connecticut, 06112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"

Exclusion criteria

  • No diagnosis of MS
  • Unable to complete the study protocol due to language barriers
  • Younger than 18 or older than 61
  • No gender exclusions
  • 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"

Treatment and study plan

Prospective Memory Intervention

Behavioral

Cognitive remediation focusing on prospective memory

Educational

Behavioral

Psychoeducation

Primary outcomes

  1. Memory for Intentions Test Total Score Percentile

    Time frame: Six weeks

    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.

  2. Memory for Intentions Test Time Cue Subscale Percentile

    Time frame: Six weeks

    Performance on objective prospective memory (time-based)

Secondary outcomes

  1. Perceived Deficits Questionnaire-Prospective Memory Subscale

    Time frame: Six weeks

    Subjective prospective memory. The five items in the subscale are summed, with scores ranging between 0 and 20. Higher scores indicate more subjective prospective memory issues.

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Registry information

Official study title

Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial

Acronym: TPMI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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