Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
This study is a pilot clinical trial to assess the feasibility of implementing a group-psychotherapy intervention to modify emotional stress (e.g., anxiety, depression, post-traumatic stress) following ICU hospitalization
详细描述
Psychological symptoms and emotional distress, including anxiety, depression, and posttraumatic stress, are common problems among patients discharged from the intensive care unit (ICU). The presence of psychological distress is associated with poor medical adherence, slower recovery, and reduced quality of life in this patient population. There is a lack of research on evidence-based interventions to address mental health symptoms in ICU patients post-hospitalization. Researchers have recently highlighted the potential utility of peer support/group interventions in the post-ICU recovery process; however, they have yet to be widely tested in interventional trials, and their feasibility and acceptability in the post-ICU population have yet to be demonstrated in a research study. Thus, the purpose of this study is to adapt and deliver a 6-session group-based psychological intervention for post-ICU patients in a single-arm, non-randomized interventional study. Patients' symptoms will be assessed at baseline, post-intervention, and 3-month follow-up. The primary aim of the study is to assess the feasibility and acceptability of the group intervention in the post-ICU patient population. Secondarily, changes in patients' emotional distress will be examined to assess for the impact of the intervention on patients' symptoms.
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
- •Aged at least 18 years
- •ICU stay of at least 3 days
- •Access to a smartphone, laptop, or computer and able to participate in a meeting via a virtual platform
- •Montreal Cognitive Assessment (MoCA)-BLIND score of at least 18
- •English fluency
- •Screening questionnaires consistent with clinically significant depression OR anxiety (Hospital Anxiety and Depression Scale-Depression [HADS-D] OR HADS-Anxiety [HADS- A] score of >7) OR Post-traumatic Stress (PTSD Checklist-Civilian Version [PCL-C] score of ≥ 30)
- •Resides in the state of Massachusetts.
排除标准
- •Unable or unwilling to participate in 6 weekly sessions of group therapy
- •Permanent or severe cognitive impairment severe enough to impede participation (as assessed via the MMSE).
结局指标
主要结局
Feasibility of recruitment
时间窗: Baseline
This will be determined by reporting the number of patients who meet study criteria who agreed to participate.
Adherence to sessions (acceptability)
时间窗: At 6 weeks (immediately at end of intervention sessions)
This will be determined by reporting the number of intervention sessions completed by each participant.
Feasibility of data collection at follow-up
时间窗: At 3 months follow-up
This will be determined by reporting the number of participants who provide follow-up data.
Feasibility of data collection at post-treatment
时间窗: At 6 weeks (immediately at end of intervention sessions)
This will be determined by reporting the number of participants who provide post-treatment data.
Client Satisfaction Questionnaire
时间窗: At 6 weeks (immediately at end of intervention sessions)
This measure assesses participants' satisfaction with the intervention (participant ratings of 1 to 4, higher scores indicate higher satisfaction).
Credibility and Expectancy Questionnaire
时间窗: Baseline
This measure assesses participants' expectations and beliefs that the intervention will be helpful (Participant ratings of 1 to 9, higher scores indicate higher beliefs that the intervention will be helpful).
次要结局
- PTSD Checklist-Civilian Version (PCL-C)(Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up)
- Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Anxiety(Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up)
- Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)- Depression(Change from Baseline to immediately Post-Intervention (at 6 weeks), and from Baseline to to 3-months Follow-up)
研究者
Katherine Berg
Assistant Professor
Beth Israel Deaconess Medical Center
