Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis

NCT04953689 | Completed

• 1 other identifier: STUDY00003473
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

neuropsychology; multiple sclerosis; conscientiousness; mobile application; smartphone application; employment; quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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.

• Beck Anxiety Inventory (BAI): 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.

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Conscientiousness Coach

Waitlist Control

NO INTERVENTION

Interventions

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.

Also known as: C.Coach, C.App

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Conventus Building

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• 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.

  PMID: 35462870 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group is assigned the intervention, one group is assigned to a waitlist control condition.

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 8, 2021
• Study Start: October 19, 2021
• Primary Completion: June 1, 2024
• Study Completion: October 28, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)