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Technology-assisted Conscientiousness Therapy for People With Multiple Sclerosis (TACT-MS)

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Conscientiousness Coach

Study type

Interventional

Funder types

Other

Identifiers

NCT04953689
STUDY00003473

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention
Experimental group
Treatment:
Behavioral: Conscientiousness Coach
Waitlist Control
No Intervention group

Trial contacts and locations

1

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Central trial contact

Michael Jaworski, BA

Data sourced from clinicaltrials.gov

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