Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
研究概览
简要总结
This pilot randomized controlled trial investigates a novel, group-based emotion regulation skills training intervention for reducing anxious and depressive symptomatology and improving emotion regulation and problem solving in individuals with MS and the individual's support partners. Participants will be randomized (1:1) to the intervention ("Partnered Emotion Regulation Skills Intervention and Supportive Teaching [PERSIST]") or to the active control (Facilitated Peer Support).
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
- Double (Participant, Outcomes Assessor)
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
- •at least 18 years old
- •able to speak/read in English
- •able to commit to attending at least 9 of the 12 weekly group sessions
- •individuals with MS must be relapse/exacerbation-free for at least 1 month
- •support partners must score at least 8 on the HADS-D or HADS-A
- •individuals with MS must score a least 11 on the HADS-D or HADS-A
排除标准
- •under 18 years old
- •unable to speak/read in English
- •unable to commit to attending at least 9 of the 12 weekly group sessions
- •MS relapse within 1 month
研究组 & 干预措施
Facilitated Peer Support
Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
干预措施: Facilitated Peer Support (Behavioral)
PERSIST
Participants will receive Partnered Emotion Regulation Skills Intervention and Support.
干预措施: PERSIST (Behavioral)
结局指标
主要结局
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
时间窗: Baseline, 13 and 26 weeks
The HADS-D is a 7-item subscale of the HADS that measures depressive symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater depressive symptomatology.
Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)
时间窗: Baseline, 13 and 26 weeks
The HADS-A is a 7-item subscale of the HADS that measures anxious symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater anxious symptomatology.
次要结局
- Change in Zarit Burden Interview (ZBI) score(Baseline, 13 weeks, and 26 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS-16) score(Baseline, 13 and 26 weeks)
- Change in Problem Solving Inventory (PSI) score(Baseline, 13 and 26 weeks)
- Change in RAND 36-Item Short Form Health Survey (SF-36) score(Baseline, 13 weeks, and 26 weeks)