Multiple SclerosisTACT-MSNCT04953689
Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
A study testing Conscientiousness Coach in people with Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Conscientiousness Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Does not meet one or more of the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Conscientiousness Coach
- Keywords
- neuropsychology, multiple sclerosis, conscientiousness, mobile application, smartphone application, employment, quality of life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscientiousness CoachBehavioural
Also called C.Coach, C.App
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Conscientiousness Coach |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, Week 12, and Week 24.
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.
Measured: At baseline, Week 12, and Week 24
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.
Measured: At baseline, Week 12, and Week 24
Secondary outcomes (8)
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.
Measured: At baseline, Week 12, and Week 24.
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.
Measured: 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
Quantifies depression symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of depression.
Measured: At baseline, Week 12, and Week 24.
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.
Measured: 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
Measures work-related problems in multiple sclerosis patients. Scale of 0-100 with higher scores indicating greater work difficulty.
Measured: At baseline, Week 12, and Week 24.
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.
Measured: At baseline only
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.
Measured: At baseline only
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.
Measured: At baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start19 Oct 2021
- Primary completion1 Jun 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group is assigned the intervention, one group is assigned to a waitlist control condition.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph H.B. Benedict, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953689
- Sponsor's protocol ID
- STUDY00003473
- Acronym
- TACT-MS
- Status last verified
- Oct 2024
- First submitted
- 18 Jun 2021
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35462870
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04953689
- Acronym / sponsor ID
- TACT-MS / STUDY00003473
- Conditions
- Multiple Sclerosis
- Keywords
- neuropsychology, multiple sclerosis, conscientiousness, mobile application, smartphone application, employment, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group is assigned the intervention, one group is assigned to a waitlist control condition.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Conscientiousness Coach |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Does not meet one or more of the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conscientiousness CoachAlso: C.Coach, C.AppParticipants 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. | Behavioural | Intervention |
Primary outcome
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.
8 secondary outcomes
NEO Five Factor Inventory (NEOFFI): change from baseline to 12 weeks and from baseline to 24 weeks
Time frame: At baseline, Week 12, and Week 24.
Quality of Life in Neurological Disorders (NeuroQol): change from baseline to 12 weeks and from baseline to 24 weeks
Time frame: 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
Time frame: At baseline, Week 12, and Week 24.
Beck Anxiety Inventory (BAI): change from baseline to 12 weeks and from baseline to 24 weeks
Time frame: 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
Time frame: At baseline, Week 12, and Week 24.
The Symbol Digit Modalities Test (SDMT)
Time frame: At baseline only
The California Verbal Learning Test Second Edition (CVLT2)
Time frame: At baseline only
The Brief Visuospatial Memory Test Revised (BVMTR)
Time frame: At baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Background: PubMed 35462870Fuchs 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.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscientiousness Coach in people with Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.