Clinical trial NCT04953689: Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
Official title: Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: neuropsychology
multiple sclerosis
conscientiousness
mobile application
smartphone application
employment
quality of life
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group is assigned the intervention, one group is assigned to a waitlist control condition.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: Buffalo Vocational Monitoring Survey (BVMS): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24
measure: The Valued Living Questionnaire (VLQ): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24
Secondary outcomes:
measure: NEO Five Factor Inventory (NEOFFI): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: Quality of Life in Neurological Disorders (NeuroQol): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: Beck Depression Inventory 2nd Edition (BDI-II): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23): change from baseline to 12 weeks and from baseline to 24 weeks
timeFrame: At baseline, Week 12, and Week 24.
measure: The Symbol Digit Modalities Test (SDMT)
timeFrame: At baseline only
measure: The California Verbal Learning Test Second Edition (CVLT2)
timeFrame: At baseline only
measure: The Brief Visuospatial Memory Test Revised (BVMTR)
timeFrame: At baseline only
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Conventus Building
state: New York
Study officials:
References:
citation: Fuchs TA, Jaworski MG 3rd, Youngs M, Abdel-Kerim O, Wojcik C, Weinstock-Guttman B, Benedict RHB. Preliminary Support of a Behavioral Intervention for Trait Conscientiousness in Multiple Sclerosis. Int J MS Care. 2022 Mar-Apr;24(2):45-53. doi: 10.7224/1537-2073.2021-005. Epub 2021 Jul 9.