Multiple Sclerosis Clinical Trial
Official title:
Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | East Hanover | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | Craig Hospital, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multiple Sclerosis Self-Efficacy Scale | This scale measures self-efficacy related to the experience of MS symptoms and sequelae. Scores range from 14-84. Higher scores indicate greater self-efficacy. | Through study completion, an average of 6 months | |
Primary | General Self-Efficacy Scale | This scale measures one's general ability to control their behaviors and execute goals. Scores range from 10-44. Higher scores indicate greater self-efficacy | Through study completion, an average of 6 months | |
Secondary | Health Status Questionnaire | The Health Status Questionnaire consists for 8 scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Scores for each scale range from 0-100. Higher scores indicate less disability. | Through study completion, an average of 6 months | |
Secondary | Satisfaction with Life Scale | This scale measures global assessment of one's life on a scale of 5-35. Higher scores indicate greater satisfaction. | Through study completion, an average of 6 months | |
Secondary | Ryff Psychological Well-being Scales | This is a global assessment of quality of life. Scores range from 14-84. Higher scores indicate greater well-being. | Through study completion, an average of 6 months | |
Secondary | Participation Assessment with Recombined Tools-Objective (PART-O) | PART-O measures three domains of participation: Productivity; Social Relations; and Out and About. The short form consists of 17 items. Items are scored on a scale from 0 to 5, with higher scores indicating greater participation | Through study completion, an average of 6 months | |
Secondary | Chicago Multiscale Depression Inventory | This scale measures emotional distress among people with non-psychiatric medical illness across three scales: Mood, Evaluative, and Vegetative. 42 items are scored on a scale Higher scores indicate more negative affect. | Through study completion, an average of 6 months | |
Secondary | State Trait Anxiety Scale | This scale measures momentary (state anxiety) and general (trait anxiety). Scores range from 20-80. Higher scores indicate greater anxiety | Through study completion, an average of 6 months | |
Secondary | Connor-Davidson Resilience Scale | The Connor-Davidson Resilience scale (CD-RISC) measures stress-coping ability. The CD-RISC comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. | Through study completion, an average of 6 months | |
Secondary | Benefit Finding in Multiple Sclerosis Scale | This scale measures finding meaning and positive adjustment to MS. Scores range from 43-139. Higher scores indicate greater benefit finding. | Through study completion, an average of 6 months | |
Secondary | Cope Inventory | This instrument evaluates coping strategies. 28 items, scored from one ("I haven't been doing this at all") to four ("I've been doing this a lot"), exploring 14 strategies: active coping, planning, use of instrumental support, positive reframing, acceptance, use of emotional support, denial, venting, self-blame, humor, religion, self-distraction, substance use and behavioral disengagement. Higher scores reflect a higher tendency to implement the corresponding coping strategies. | Through study completion, an average of 6 months |
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