Multiple Sclerosis
Conditions
Keywords
prospective memory, cognitive dysfunction, multiple sclerosis
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.
Interventions
BEHAVIORALProspective Memory Intervention
Cognitive remediation focusing on prospective memory
BEHAVIORALEducational
Psychoeducation
Sponsors
Trinity Health Of New England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory for Intentions Test Total Score Percentile | 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. |
| Memory for Intentions Test Time Cue Subscale Percentile | Six weeks | Performance on objective prospective memory (time-based) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Deficits Questionnaire-Prospective Memory Subscale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Educational | Total | Prospective Memory Intervention |
|---|---|---|---|
| Age, Continuous | 48.17 years STANDARD_DEVIATION 9.8 | 47.74 years STANDARD_DEVIATION 9.37 | 47.29 years STANDARD_DEVIATION 9.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Multi-racial/Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 16 Participants | 28 Participants | 12 Participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Memory for Intentions Test Time Cue Subscale Percentile
Performance on objective prospective memory (time-based)
Time frame: Six weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Memory Intervention | Memory for Intentions Test Time Cue Subscale Percentile | Baseline | 35.00 Percentile | Standard Deviation 19.75 |
| Prospective Memory Intervention | Memory for Intentions Test Time Cue Subscale Percentile | Post-treatment | 57.89 Percentile | Standard Deviation 30.53 |
| Educational | Memory for Intentions Test Time Cue Subscale Percentile | Baseline | 51.78 Percentile | Standard Deviation 24.09 |
| Educational | Memory for Intentions Test Time Cue Subscale Percentile | Post-treatment | 59.52 Percentile | Standard Deviation 29.89 |
p-value: 0.04ANCOVA
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Memory Intervention | Memory for Intentions Test Total Score Percentile | Baseline | 32.24 Percentile | Standard Deviation 21.78 |
| Prospective Memory Intervention | Memory for Intentions Test Total Score Percentile | Post-Treatment | 35.02 Percentile | Standard Deviation 22.77 |
| Educational | Memory for Intentions Test Total Score Percentile | Baseline | 38.94 Percentile | Standard Deviation 24.29 |
| Educational | Memory for Intentions Test Total Score Percentile | Post-Treatment | 45.40 Percentile | Standard Deviation 36.62 |
p-value: 0.229ANCOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Memory Intervention | Perceived Deficits Questionnaire-Prospective Memory Subscale | Baseline | 10.18 score on a scale | Standard Deviation 2.7 |
| Prospective Memory Intervention | Perceived Deficits Questionnaire-Prospective Memory Subscale | Post-Treatment | 8.79 score on a scale | Standard Deviation 2.6 |
| Educational | Perceived Deficits Questionnaire-Prospective Memory Subscale | Baseline | 8.44 score on a scale | Standard Deviation 2.55 |
| Educational | Perceived Deficits Questionnaire-Prospective Memory Subscale | Post-Treatment | 8.30 score on a scale | Standard Deviation 2.74 |
p-value: 0.266ANCOVA