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临床试验/NCT05856240
NCT05856240撤回不适用

Targeted Group-based Psychotherapy to Address Emotional Stress in at Risk ICU Survivors: A Pilot Feasibility Study

Beth Israel Deaconess Medical Center0 个研究点开始时间: 2023年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Berg

Assistant Professor

Beth Israel Deaconess Medical Center

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