Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis

NCT ID: NCT04953689

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-10-28

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Conscientiousness Coach

Intervention Type: 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.

Waitlist Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conscientiousness Coach

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

C.Coach; C.App

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Ralph H.B. Benedict

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Conventus Building

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35462870 (View on PubMed)

Other Identifiers

STUDY00003473

Identifier Type: -

Identifier Source: org_study_id