Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2021-11-01
2023-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Prospective Memory Intervention
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.
Prospective Memory Intervention
Cognitive remediation focusing on prospective memory
Educational
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.
Educational
Psychoeducation
Interventions
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Prospective Memory Intervention
Cognitive remediation focusing on prospective memory
Educational
Psychoeducation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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"
18 Years
60 Years
ALL
No
Sponsors
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Trinity Health Of New England
OTHER
Responsible Party
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Locations
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Mount Sinai Rehabilitation Hospital
Hartford, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MSH 21-63
Identifier Type: -
Identifier Source: org_study_id
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