Meeting an Unmet Need in Multiple Sclerosis (MS): An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) - Change in Depression
研究概览
简要总结
The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.
详细描述
The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.
To achieve this, the investigation has the following specific aims:
Specific Aim 1: Conduct a pilot Randomized Controlled Trial (RCT) of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety.
Hypothesis 1: Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group.
Specific Aim 2: Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being, QOL, coping, and MS symptomatology over time.
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)
盲法说明
The assessor is blinded to the group assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis
- •18 years of age or older
- •Experiencing significant depression and/or anxiety
- •English-speaking
- •Able to provide informed consent
- •Access to the internet
排除标准
- •History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
- •Current participation in another randomized controlled trial
- •Cognitive impairment that would affect my ability to fully participate in the group
- •Unable to attend group sessions
- •Active participation in another formal clinical group or psychological therapy
- •Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) - Change in Depression
时间窗: Baseline, 12 weeks, 24 weeks
Self-report measure of depression. Scores range from 0-21 with higher scores indicating greater depression.
Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety
时间窗: Baseline, 12 weeks, 24 weeks
Self-report measure of anxiety. Scores range from 0-21 with higher scores indicating greater anxiety.
次要结局
- University of Washington Self-Efficacy Scale - Change in MS specific self-efficacy(Baseline, 12 weeks, 24 weeks)
- University of Washington Resilience Scale - Change in Resilience(Baseline, 12 weeks, 24 weeks)
- COPE inventory - Change in Coping(Baseline, 12 weeks, 24 weeks)
- Modified Fatigue Impact Scale (MFIS) - Change in Fatigue(Baseline, 12 weeks, 24 weeks)
- MOS Pain Effects Scale (PES) - Change in Pain(Baseline, 12 weeks, 24 weeks)
- Benefit Finding in Multiple Sclerosis (BFIMS) - Change in Benefit-finding(Baseline, 12 weeks, 24 weeks)
- Flourishing Scale (FS) - Change in Quality of Life(Baseline, 12 weeks, 24 weeks)
- Pittsburgh Sleep Quality Index (PQSI) - Change in Sleep(Baseline, 12 weeks, 24 weeks)
- Satisfaction with Life Scale (SWLS) - Changes in Quality of Life(Baseline, 12 weeks, 24 weeks)
- General Self-Efficacy Scale (GSES) - Change in Self-efficacy(Baseline, 12 weeks, 24 weeks)
- Ryff Psychological Well-being Scales (RYFFPWB) - Changes in well-being(Baseline, 12 weeks, 24 weeks)
研究者
Lauren Strober
Principle Investigator
Kessler Foundation