Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis (TACT-MS)
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conscientiousness Coach
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring neuropsychology, multiple sclerosis, conscientiousness, mobile application, smartphone application, employment, quality of life
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of Multiple Sclerosis.
- Is above 18 years of age.
- Is currently employed full- or part- time
- No history of substance dependence/abuse, psychiatric disorders, or any neurological disease other than MS
- 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
- Has NEO-FFI Conscientiousness score above t=40
Sites / Locations
- Conventus BuildingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Waitlist Control
Arm Description
Outcomes
Primary Outcome Measures
Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks
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
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
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 Outcome Measures
NEO Five Factor Inventory (NEOFFI): change from baseline to 12 weeks and from baseline to 24 weeks
Personality inventory measuring five primary domains of personality: neuroticism, extraversion, openness, agreeableness, and conscientiousness. Total scores are 12-60 on each domain's scale, with higher scores indicating higher levels of that personality trait.
Quality of Life in Neurological Disorders (NeuroQol): change from baseline to 12 weeks and from baseline to 24 weeks
Measure of quality of life for neurology patients. We are using the four subscales of Communication, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, and Positive Affect and Well Being. T-scores are used with higher T-scores indicating greater quality of life in each respective domain.
Beck Depression Inventory 2nd Edition (BDI-II): change from baseline to 12 weeks and from baseline to 24 weeks
Quantifies depression symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of depression.
Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks
Quantifies anxiety symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of anxiety.
Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23): change from baseline to 12 weeks and from baseline to 24 weeks
Measures work-related problems in multiple sclerosis patients. Scale of 0-100 with higher scores indicating greater work difficulty.
The Symbol Digit Modalities Test (SDMT)
Presents a series of nine symbols, each paired with a single digit in a key at the top of a stimulus page. Subjects voice the number associated with each symbol as rapidly as possible. Measures cognitive processing speed. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance.
The California Verbal Learning Test Second Edition (CVLT2)
Measures verbal learning and memory. Begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials, and a delayed recall trial after 20 minutes. Minimum of 0, maximum of 80 on learning trials. Minimum of 0, maximum of 16 on delayed recall trial. Higher score indicates better performance.
The Brief Visuospatial Memory Test Revised (BVMTR)
Measures visual/spatial memory. Presents six abstract designs for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. There are three learning trials and a delayed recall trial after 20 minutes. Minimum of 0, maximum of 36 on learning trials. Minimum of 0, maximum of 12 on delayed recall trial. Higher score indicates better performance.
Full Information
NCT ID
NCT04953689
First Posted
June 18, 2021
Last Updated
April 11, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT04953689
Brief Title
Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
Acronym
TACT-MS
Official Title
Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
neuropsychology, multiple sclerosis, conscientiousness, mobile application, smartphone application, employment, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group is assigned the intervention, one group is assigned to a waitlist control condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Conscientiousness Coach
Other Intervention Name(s)
C.Coach, C.App
Intervention Description
Participants will use the Conscientiousness Coach app to organize their goals and assist them in engaging in more conscientious behaviors. The participant will also be educated about Conscientiousness as it relates to healthy living and accomplishing life goals and values. Participants will receive brief phone calls during weeks 1, 2, 6, and 10 from the research assistant, tracking progress, answering queries, and return visits to the clinic/teleconference will be scheduled for further assistance during week 4 and week 8. These mid-study visits (or 'Booster Sessions') will last approximately 50 minutes and will involve a brief discussion of goal and value progress and app usage; at this in-person meeting/teleconference, similar questions and topics will be covered as in the bi-monthly phone calls. At week 12, there is a treatment termination visit with the principal investigator and research assistant.
Primary Outcome Measure Information:
Title
Self -Reflection and Insight Scale (SRIS): change from baseline to 12 weeks and from baseline to 24 weeks
Description
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.
Time Frame
At baseline, Week 12, and Week 24.
Title
Buffalo Vocational Monitoring Survey (BVMS): change from baseline to 12 weeks and from baseline to 24 weeks
Description
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.
Time Frame
At baseline, Week 12, and Week 24
Title
The Valued Living Questionnaire (VLQ): change from baseline to 12 weeks and from baseline to 24 weeks
Description
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.
Time Frame
At baseline, Week 12, and Week 24
Secondary Outcome Measure Information:
Title
NEO Five Factor Inventory (NEOFFI): change from baseline to 12 weeks and from baseline to 24 weeks
Description
Personality inventory measuring five primary domains of personality: neuroticism, extraversion, openness, agreeableness, and conscientiousness. Total scores are 12-60 on each domain's scale, with higher scores indicating higher levels of that personality trait.
Time Frame
At baseline, Week 12, and Week 24.
Title
Quality of Life in Neurological Disorders (NeuroQol): change from baseline to 12 weeks and from baseline to 24 weeks
Description
Measure of quality of life for neurology patients. We are using the four subscales of Communication, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, and Positive Affect and Well Being. T-scores are used with higher T-scores indicating greater quality of life in each respective domain.
Time Frame
At baseline, Week 12, and Week 24.
Title
Beck Depression Inventory 2nd Edition (BDI-II): change from baseline to 12 weeks and from baseline to 24 weeks
Description
Quantifies depression symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of depression.
Time Frame
At baseline, Week 12, and Week 24.
Title
Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks
Description
Quantifies anxiety symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of anxiety.
Time Frame
At baseline, Week 12, and Week 24.
Title
Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23): change from baseline to 12 weeks and from baseline to 24 weeks
Description
Measures work-related problems in multiple sclerosis patients. Scale of 0-100 with higher scores indicating greater work difficulty.
Time Frame
At baseline, Week 12, and Week 24.
Title
The Symbol Digit Modalities Test (SDMT)
Description
Presents a series of nine symbols, each paired with a single digit in a key at the top of a stimulus page. Subjects voice the number associated with each symbol as rapidly as possible. Measures cognitive processing speed. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance.
Time Frame
At baseline only
Title
The California Verbal Learning Test Second Edition (CVLT2)
Description
Measures verbal learning and memory. Begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials, and a delayed recall trial after 20 minutes. Minimum of 0, maximum of 80 on learning trials. Minimum of 0, maximum of 16 on delayed recall trial. Higher score indicates better performance.
Time Frame
At baseline only
Title
The Brief Visuospatial Memory Test Revised (BVMTR)
Description
Measures visual/spatial memory. Presents six abstract designs for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. There are three learning trials and a delayed recall trial after 20 minutes. Minimum of 0, maximum of 36 on learning trials. Minimum of 0, maximum of 12 on delayed recall trial. Higher score indicates better performance.
Time Frame
At baseline only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of Multiple Sclerosis.
Is above 18 years of age.
Is currently employed full- or part- time
No history of substance dependence/abuse, psychiatric disorders, or any neurological disease other than MS
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
Has NEO-FFI Conscientiousness score above t=40
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Jaworski, BA
Phone
7163230550
Email
mgjawors@buffalo.edu
Facility Information:
Facility Name
Conventus Building
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Jaworski, BA
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35462870
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.
Results Reference
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Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
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