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Reinventing Yourself With Multiple Sclerosis (MS)

2022年10月12日 更新者：Kessler Foundation

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Multiple sclerosis (MS) is the leading cause of disability among middle-aged adults with recent estimates of nearly 1 million adults living with MS in the United States. Multiple sclerosis affects women anywhere from two to three times as often as men, with an age of diagnosis ranging from 20 to 50 years of age and a mean age of onset of 33 years of age. A host of physical, cognitive, and behavioral changes are common following the onset of this most common non-traumatic neurological disorder of middle adulthood, which greatly impacts quality of life (QOL), well-being, and everyday functioning and participation. Moreover, given that individuals are typically diagnosed with MS in the prime of their lives many are making important life decisions regarding work, family, etc. that are often hindered by their diagnosis. In fact, it has been found that men and women with MS aged 25-44, an age at which important early life decisions are often made, experienced more depression than their age-matched, healthy counterparts. Again, the course of the disease is variable and unpredictable with no known cure, which can lead to great uncertainty and difficulty in adjusting to a chronic and often, debilitating disease.

The overarching aim of the proposed investigation is to adapt the Reinventing Yourself intervention for use with MS and examine the feasibility and efficacy in increasing MS-specific and general self-efficacy and resilience, enhancing psychological well-being, fostering new ways of perceiving and managing one's illness in more proactive and positive ways, and improving participation in the community. To achieve this, the investigation has the following specific aims:

Specific Aim 1: Conduct a focus group with individuals with MS to identify unique needs of individuals with MS with regard to MS symptoms, barriers to well-being, QOL, and participation, and the role that person-specific factors (e.g., self-efficacy, resilience) and other psychological and social factors have contributed to success (or failure) in managing one's illness and living well.

Specific Aim 2: With the knowledge gained from Aim 1, modify the Reinventing Yourself intervention with the specific needs of MS, while maintaining the integrity and common principles of the Reinventing Yourself intervention.

Specific Aim 3: Conduct a RCT among individuals with MS to determine the feasibility and efficacy of the Reinventing Yourself with MS intervention.

研究の種類

介入

入学 (予想される)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：Reinvention with MS
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
プラセボコンパレーター：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.
行動：Reinvention with MS
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Multiple Sclerosis Self-Efficacy Scale
時間枠：Through study completion, an average of 6 months
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
General Self-Efficacy Scale
時間枠：Through study completion, an average of 6 months
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

二次結果の測定

結果測定
メジャーの説明
時間枠
Health Status Questionnaire
時間枠：Through study completion, an average of 6 months
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
Satisfaction with Life Scale
時間枠：Through study completion, an average of 6 months
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
Ryff Psychological Well-being Scales
時間枠：Through study completion, an average of 6 months
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
Participation Assessment with Recombined Tools-Objective (PART-O)
時間枠：Through study completion, an average of 6 months
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
Chicago Multiscale Depression Inventory
時間枠：Through study completion, an average of 6 months
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
State Trait Anxiety Scale
時間枠：Through study completion, an average of 6 months
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
Connor-Davidson Resilience Scale
時間枠：Through study completion, an average of 6 months
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
Benefit Finding in Multiple Sclerosis Scale
時間枠：Through study completion, an average of 6 months
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
Cope Inventory
時間枠：Through study completion, an average of 6 months
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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Kessler Foundation

協力者

University of Minnesota
Craig Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年8月1日

一次修了 (予想される)

2024年9月30日

研究の完了 (予想される)

2024年9月30日

試験登録日

最初に提出

2021年11月15日

QC基準を満たした最初の提出物

2022年1月4日

最初の投稿 (実際)

2022年1月18日

学習記録の更新

投稿された最後の更新 (実際)

2022年10月14日

QC基準を満たした最後の更新が送信されました

2022年10月12日

最終確認日

2022年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • R-1164-21

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

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いいえ

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