Reinventing Yourself With Multiple Sclerosis (MS)
Reinventing Yourself With Multiple Sclerosis (MS): An Intervention Aimed at Improving Self-Efficacy, Coping, Psychological Well-being, and Quality of Life in MS
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Lauren Strober, PhD
- 전화번호: 973-324-8459
- 이메일: lstrober@kesslerfoundation.org
연구 연락처 백업
- 이름: Amanda L Botticello, PhD
- 전화번호: 973-243-6973
- 이메일: abotticello@kesslerfoundation.org
연구 장소
-
-
New Jersey
-
East Hanover, New Jersey, 미국, 07036
- 모병
- Kessler Foundation
-
연락하다:
- Rachel Byrne, MA
- 전화번호: 973-324-3567
- 이메일: rbyrne@kesslerfoundation.org
-
연락하다:
- Lauren Strober, PhD
- 전화번호: 973.324.8459
- 이메일: lstrober@kesslerfoundation.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
|
|
위약 비교기: 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.
|
A manualized group therapy to build self-efficacy among people living with multiple sclerosis.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Multiple Sclerosis Self-Efficacy Scale
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health Status Questionnaire
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R-1164-21
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
다발성 경화증에 대한 임상 시험
-
University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스
Reinvention with MS에 대한 임상 시험
-
University of Erlangen-Nürnberg Medical School알려지지 않은
-
University of Illinois at ChicagoCongressionally Directed Medical Research Programs모병
-
University Hospital, Basel, SwitzerlandSwiss Multiple Sclerosis Society; Bangerter-Rhyner Stiftung; Center for Chronic Immunodeficiency...모집하지 않고 적극적으로
-
Hospices Civils de Lyon완전한겸상 적혈구 질환 | 유아, 신생아, 질병 | Drepanocytosis프랑스
-
Hoffmann-La Rocheicometrix아직 모집하지 않음
-
University of California, San FranciscoUnited States Department of Defense모병
-
MingSight Pharmaceuticals, IncShenzhen MingSight Relin Pharmaceutical Co., Ltd모병만성 림프구성 백혈병(CLL) | 소림프구성 림프종(SLL) | 맨틀 세포 림프종(MCL) | 미만성 거대 B세포 림프종(DLBCL) | 여포성 림프종(FL) | 재발성 또는 불응성 B세포 림프종 | 변연부 림프종(MZL)중국
-
Friedemann PaulRoche Pharma AG모집하지 않고 적극적으로
-
Obstetrix Medical Group종료됨