Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- State University of New York at Buffalo
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment.
Detailed Description
The primary objective is to establish whether people with MS with low Conscientiousness benefit from a cognitive-behavioral, phone app intervention. Also enrolled are healthy individuals over the age of 60. This group's response to the intervention will be compared to the MS sample. The investigators also aim to determine the acceptability and utilization of the Conscientiousness-Coach phone application and intervention. It is anticipated that the Conscientiousness-Coach phone app intervention will result in fewer negative work events and increased work accommodations in those treated, relative to the control group. In exploration of other secondary outcomes, the investigators also expect that the treatment will result in increased self-report trait Conscientiousness itself, increase in structured leisure activities, reduction in depression, and reduction in anxiety. This is a prospective longitudinal design with an experimental manipulation (i.e., a randomized-controlled trial). There will be an initial assessment with neuropsychological testing, the Buffalo Vocational Monitoring Survey (BVMS), and several self-report measures, and a post-test assessment after three months and six months with these same instruments, excluding the neuropsychological assessment. The BVMS will also be administered at 0 months, 3 months, and 6 months to further assess post-treatment effects.
Investigators
Ralph H.B. Benedict
Professor
State University of New York at Buffalo
Eligibility Criteria
Inclusion Criteria
- •Has a diagnosis of Multiple Sclerosis or is over 60 years of age.
- •If an MS patient: is above 18 years of age.
- •No history of substance dependence/abuse, psychiatric disorders, or any neurological disease other than MS
- •If an MS patient: has a NEO-FFI Conscientiousness score that is one standard deviation or more below the healthy adult mean (t=40)
Exclusion Criteria
- •Does not meet one or more of the above inclusion criteria
Outcomes
Primary Outcomes
Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks
Time Frame: At baseline, Week 12, and Week 24.
20 question self-report measure which assesses participants private self-consciousness using self-reflection and insight components. Total score of 20-120 points is calculated, with higher scores indicating greater self-reflection and insight.
Buffalo Vocational Monitoring Survey (BVMS): change from baseline to 12 weeks and from baseline to 24 weeks
Time Frame: At baseline, Week 12, and Week 24
Assesses general employment information (e.g. number of hours worked per week, job title, and income) and work-related problems and accommodations. Participants will identify specific negative work events (e.g. formal reprimand) experienced in the past 3 months and provide a list of job accommodations to endorse if they are receiving them at the time of survey. Income, number of hours worked per week, number of negative work events (0 to 7, with higher number indicating more negative work events), and number of accommodations (0 to 40, with higher number indicating more accommodations) will be used as outcomes from this survey.
The Valued Living Questionnaire (VLQ): change from baseline to 12 weeks and from baseline to 24 weeks
Time Frame: At baseline, Week 12, and Week 24
Assesses valued living, or the extent to which an individual contacts his or her chosen values in everyday life. Respondents are asked to rate the 10 areas of life on a scale of 1-10, indicating the level of importance and how consistently they have lived in accord with those values in the past week. The composite score is used (1-100 points), with higher scores indicating a greater extent to which one is living out particular values in everyday life.
Secondary Outcomes
- NEO Five Factor Inventory (NEOFFI): change from baseline to 12 weeks and from baseline to 24 weeks(At baseline, Week 12, and Week 24.)
- Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks(At baseline, Week 12, and Week 24.)
- Beck Depression Inventory 2nd Edition (BDI-II): change from baseline to 12 weeks and from baseline to 24 weeks(At baseline, Week 12, and Week 24.)
- The Brief Visuospatial Memory Test Revised (BVMTR)(At baseline only)
- The California Verbal Learning Test Second Edition (CVLT2)(At baseline only)
- The Symbol Digit Modalities Test (SDMT)(At baseline only)
- Quality of Life in Neurological Disorders (NeuroQol): change from baseline to 12 weeks and from baseline to 24 weeks(At baseline, Week 12, and Week 24.)
- Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23): change from baseline to 12 weeks and from baseline to 24 weeks(At baseline, Week 12, and Week 24.)