An interventional study of Prospective Memory Intervention and Educational in Multiple Sclerosis, sponsored by Trinity Health Of New England. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Trinity Health Of New England · Not applicable, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Trinity Health Of New England is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Cognitive remediation focusing on prospective memory
Psychoeducation
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.
Time frame: Six weeks
Memory for Intentions Test Time Cue Subscale Percentile
Performance on objective prospective memory (time-based)
Time frame: Six weeks
Perceived Deficits Questionnaire-Prospective Memory Subscale
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.
Time frame: Six weeks
| Milestone | Prospective Memory Intervention | Educational |
|---|---|---|
| Started | 17 | 18 |
| Completed | 15 | 16 |
| Not completed | 2 | 2 |
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.
| Percentile | Prospective Memory Intervention | Educational |
|---|---|---|
| Baseline | 32.24 ± 21.78 | 38.94 ± 24.29 |
| Post-Treatment | 35.02 ± 22.77 | 45.40 ± 36.62 |
Performance on objective prospective memory (time-based)
| Percentile | Prospective Memory Intervention | Educational |
|---|---|---|
| Baseline | 35.00 ± 19.75 | 51.78 ± 24.09 |
| Post-treatment | 57.89 ± 30.53 | 59.52 ± 29.89 |
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.
| score on a scale | Prospective Memory Intervention | Educational |
|---|---|---|
| Baseline | 10.18 ± 2.70 | 8.44 ± 2.55 |
| Post-Treatment | 8.79 ± 2.60 | 8.30 ± 2.74 |
Collected over Six weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Memory Intervention | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Educational | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Prospective Memory Intervention | Educational | Total |
|---|---|---|---|
| Mean | 47.29 ± 9.15 | 48.17 ± 9.8 | 47.74 ± 9.37 |
| Sex: Female, Male(Participants) | Prospective Memory Intervention | Educational | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Prospective Memory Intervention | Educational | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 15 | 14 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Prospective Memory Intervention | Educational | Total |
|---|---|---|---|
| Race — White | 12 | 16 | 28 |
| Race — Black | 3 | 1 | 4 |
| Race — Multi-racial/Other | 2 | 1 | 3 |
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Trinity Health Of New England