Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT05195320

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reinvention with MS

Study Details

Brief summary:

Given the knowledge that detriments in QOL, well-being, and participation are common in MS and attributable in a large part to individual, person-specific factors (e.g., self-efficacy), efforts to develop interventions aimed at addressing these factors is well needed and likely to have a significant impact. The proposed investigation will consist of two phases involving participant recruitment and data collection. Phase 1 will consist of a focus group aimed at identifying the unique needs of individuals with MS, and findings will be used to adapt the Reinventing Yourself after Spinal Cord Injury (SCI) intervention to Reinventing Yourself with MS. Phase 2 will consist of a randomized controlled trial (RCT) in which the feasibility and efficacy of the intervention in a new population can be examined.

Conditions

Multiple Sclerosis

Study ID

NCT05195320

Start date

Aug 1, 2022

Status verified date

Oct, 2022

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of multiple sclerosis
  • 18 years of age or older
  • English-speaking
  • Able to provide informed consent
  • Access to the internet (if needed should the groups have to be conducted online due to pandemic circumstances that may limit to in-person meetings).

Exclusion Criteria:

  • History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
  • Cognitive impairment that would affect my ability to fully participate in the group
  • (For in-person group): Live beyond a reasonable commuting distance (50+ miles)
  • Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group Intervention

Participants will attend six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion. These skills are presented in sequence over the course of the intervention so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex. The culmination of developing these skills and participation in a peer group will assist individuals in increasing self-efficacy and overall QOL, well-being and participation. Participants will complete follow-up assessment at 18- and 30-weeks post-intervention.

placebo comparator: Placebo

Participants will receive no intervention throughout the course of the study; however, the participants will be tested at 18- and 30-weeks participation in the study.

Interventions

Reinvention with MS

A manualized group therapy to build self-efficacy among people living with multiple sclerosis.

Primary outcome measure

  • Multiple Sclerosis Self-Efficacy Scale [ Time Frame: Through study completion, an average of 6 months ]
  • General Self-Efficacy Scale [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Lauren Strober, PhD

973-324-8459lstrober@kesslerfoundation.org

Amanda L Botticello, PhD

973-243-6973abotticello@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07036

Contacts

Rachel Byrne, MA

973-324-3567rbyrne@kesslerfoundation.org

Lauren Strober, PhD

973.324.8459lstrober@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-10-14.