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Completed

NCT Number: NCT04953689

Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis

This is a validation study of a conscientiousness-based phone app intervention strategy to help people with their health management and employment.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Conventus Building

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conscientiousness Coach

Behavioral

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.

Other names: C.Coach, C.App

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    Quantifies depression symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of depression.

  4. 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.

    Quantifies anxiety symptoms. Minimum of 0, maximum of 63. Higher score indicates higher levels of anxiety.

  5. 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.

    Measures work-related problems in multiple sclerosis patients. Scale of 0-100 with higher scores indicating greater work difficulty.

  6. The Symbol Digit Modalities Test (SDMT)

    Time frame: At baseline only

    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.

  7. The California Verbal Learning Test Second Edition (CVLT2)

    Time frame: At baseline only

    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.

  8. The Brief Visuospatial Memory Test Revised (BVMTR)

    Time frame: At baseline only

    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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Acronym: TACT-MS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2021
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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