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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Memory Intervention | Experimental | 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. |
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| Educational | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective Memory Intervention | Behavioral | Cognitive remediation focusing on prospective memory |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six weeks |
| Memory for Intentions Test Time Cue Subscale Percentile | Performance on objective prospective memory (time-based) | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Rehabilitation Hospital | Hartford | Connecticut | 06112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percentile | Six weeks |
|
Six weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mandell Center Research Team | Trinity Health Of New England | 860-714-3005 | MSResearch@TrinityHealthOfNE.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2022 | Jun 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Educational | Behavioral | Psychoeducation |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | 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 |
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| Primary | Memory for Intentions Test Time Cue Subscale Percentile | Performance on objective prospective memory (time-based) | Posted | Mean | Standard Deviation | Percentile | Six weeks |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Six weeks |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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 | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |