Effects of an Educational Socialization Program Designed to Improve Self-Efficacy and Subsequent Effects on Decreasing Loneliness and Depression Among People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Self-Efficacy Scale (MSSS)
研究概览
简要总结
The purpose of this study is to examine the effects of an innovative program, entitled CRISP (Community Integration for Socially Isolated Patients), on improving self-efficacy and assessing whether improved self-efficacy helps to reduce depression and loneliness of people with MS.
详细描述
Whether CRISP increases self-efficacy while decreasing loneliness and depression
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years old.
- •Must have a definitive diagnosis of MS by a physician.
- •Must understand English at 6th grade level since the CRISP program requires participants to comprehend the educational information presented in English.
- •Agree to participate in 12 group sessions over 12 weeks;
- •Must have the ability to complete questionnaires in English since the outcome measures used for the study are in English.
- •Must be able to commute to the site destinations
排除标准
- •Have an actively psychotic Axis I disorder.
- •Have a significant Axis II disorder of borderline personality disorder or schizoid personality disorder.
- •Have a diagnosis of another neurological condition aside from MS.
- •Inability to comply with study requirements/visits.
研究组 & 干预措施
CRISP program
educational and socialization program
干预措施: CRISP Program (Behavioral)
Control Group
no treatment control group
干预措施: Control Group (Other)
结局指标
主要结局
Multiple Sclerosis Self-Efficacy Scale (MSSS)
时间窗: Change from Baseline to week 12
The Multiple Sclerosis Self-Efficacy Scale (MSSS) is designed to measure self-efficacy in people diagnosed with MS. The MSSS incorporates aspects of social interaction and themes related to beliefs of control over future events, which is based on Bandura's definition of self-efficacy (Rigby et al., 2003). The MSSS is a 14 item, six-point Likert scale and participants are asked to rate their level of agreement or disagreement for each item on the scale ranging from 'strongly disagree' (1) to 'strongly agree' (6). Examples of questions include "sometimes I feel embarrassed in public places" or "I have as much independence as I need." Scores can range from 14 (low self-efficacy) to 84 (high self-efficacy).
次要结局
- Performance Scales (PS)(Change from Baseline to week 12)
- UCLA Revised Loneliness Scale(Change from Baseline to week 12)
- Community Integration Questionnaire (CIQ)(Change from Baseline to week 12)
- Chicago Multiscale Depression Inventory (CMDI)(Change from Baseline to week 12)
研究者
J. Tamar Kalina
Program Manager
NYU Langone Health