Resilient Together-ALS (RT-ALS): A Dyadic Mind-body Meaning Intervention for People With ALS and Their Informal Care-partners
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment Satisfaction
研究概览
简要总结
The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.
详细描述
The goal of this study to refine our proposed intervention Resilient Together ALS (RT-ALS) through an open pilot. The investigators will deliver an open pilot of the intervention (N= up to10 dyads; up to 20 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.
The open pilot will take place over Zoom, with participants recruited from the Massachusetts General Hospital's Sean M. Healey and AMG Center for ALS. Study clinicians will deliver 6, 30-45 minute sessions over Zoom. All participants will complete measures at baseline and after completion of the program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback on the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •for patient with ALS:
- •recent (within ~2 months) of first appointment at Healey Center for diagnosis of ALS documented in Epic (based on recommendations from neurologists)
- •ability to understand the study and research protocol as determined by a standardized teach-back method of assessment
- •ability to communicate by writing, speaking, or assistive communication device
- •Inclusion Criteria for dyad:
- •English speaking adults
- •dyad lives together
- •at least one partner endorses clinically significant emotional distress during screening (>7 on either subscale of the HADS)
排除标准
- •patient with ALS with comorbid terminal diagnosis or severe mental health disorder that limits ability to participate (by self-report, as determined by our clinical team);
- •cognitive disorder that limits ability to participate (per neurologist)
- •inability or unwillingness to use live video technology (will teach any dyads who have low technology literacy how to use live video technology)
研究组 & 干预措施
RT-ALS Intervention
Dyads will participate in 6 30-45-minute skills based sessions. A clinical psychologist will deliver all sessions. The main intervention goal is to provide dyads with coping and resiliency skills and resources to reduce emotional distress, prevent chronic distress, and preserve quality of life for both dyad members as ALS progresses.
干预措施: Resilient Together ALS (Behavioral)
结局指标
主要结局
Treatment Satisfaction
时间窗: 6 weeks
Percentage of dyads who score above the midpoint on Client Satisfaction Questionnaire (\> 70% acceptable; \> 80% excellent)
Recruitment Feasibility
时间窗: 0 weeks
Percentage of eligible ALS patient-caregiver dyads that participate in the intervention (\>70% acceptable; \>80% excellent).
Data Collection Feasibility
时间窗: Pre-test (0 weeks) to Post-test (6 weeks)
Percentage of dyads with no missing measures (\>70% acceptable; \>80% excellent)
Adherence Feasibility
时间窗: 6 weeks
Percentage of RT-ALS dyads that complete 4/6 sessions (\>70% acceptable; \>80% excellent)
Credibility and Expectancy
时间窗: Pre-test (0 weeks)
Percentage of dyads who score above midpoint on the Credibility/Expectancy Questionnaire (\> 70% acceptable; \> 80% excellent)
Adverse Events
时间窗: 6 weeks
None or minimal adverse events
Therapist Fidelity Feasibility
时间窗: 6 weeks
Percentage of adherence checklists completed; percentage of selected sessions (20%) with 100% adherence Fidelity Checks (\>70% acceptable; \>80% excellent).
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Pre-test (0 weeks) to Post-test (6 weeks))
- The World Health Organization Quality of Life abbreviated (WHOQOL-BREF)(Pre-test (0 weeks) to Post-test (6 weeks))
- Cognitive and Affective Mindfulness Scale (CAMS)(Pre-test (0 weeks) to Post-test (6 weeks))
- Measure of Current Status Part A (MOCS-A)(Pre-test (0 weeks) to Post-test (6 weeks))
- Multidimensional Scale of Perceived Social Support (MSPSS)(Pre-test (0 weeks) to Post-test (6 weeks))
- Dyadic Coping Inventory (DCI)(Pre-test (0 weeks) to Post-test (6 weeks))
- The Meaning in Life Questionnaire (MLQ)(Pre-test (0 weeks) to Post-test (6 weeks))
研究者
Christina Rush, PhD
Principal Investigator
Massachusetts General Hospital