Improving Prospective Memory Via Telehealth

Study Overview
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Brief Summary
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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.

Official Title
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Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Prospective Memory Intervention
* Behavioral: Educational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Memory Intervention<br>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<br>* Cognitive remediation focusing on prospective memory<br>|
| Active Comparator: Educational<br>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<br>* Psychoeducation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory for Intentions Test | Performance on objective prospective memory | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prospective memory, cognitive dysfunction, multiple sclerosis