WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
研究概览
简要总结
The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
详细描述
R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.
R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistants administering the assessments will be blind to participant randomization in the R33 phase.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-90 years old
- •Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
- •Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
- •We will also include patients on psychotropics and on after-care community psychotherapy.
排除标准
- •Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
- •Cognitive Impairment (MMSE ≤ 24)
- •Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
- •Aphasia, sensory problems, and/or inability to speak English.
研究组 & 干预措施
Optimized WellPATH-PREVENT (R33)
干预措施: Optimized WellPATH-PREVENT (Behavioral)
Attention Control Usual Care (R33)
The AC-UC group will parallel the delivery of the WellPATH-PREVENT intervention and will also include: a) meetings during hospitalization: a non-clinical member of the team will present the control tablet and explain its use; b) scheduled or requested meetings through zoom: to parallel the delivery of WellPATH-PREVENT. The tablet will still have a link to schedule a meeting with a non-clinician member of the team. The meetings will focus on issues that the patient may have in using the tablet. There will not be any therapeutic or psychological interaction between participants in the control group and the team. The experimental and the control group will also be under usual outpatient care, which is arranged during the hospitalization by the inpatient treatment team.
Proof-of-Concept WellPATH-PREVENT (R61)
干预措施: WellPATH-PREVENT (Behavioral)
结局指标
主要结局
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
时间窗: Study Entry, Week 6, Week 12, Week 24
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
时间窗: Weekly from Study Entry to Week 12 (R61)
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
时间窗: Weekly from Study Entry to Week 24
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
时间窗: Study Entry, Week 6, Week 12, Week 24
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Change in Self-Reported Affect - R33
时间窗: Study Entry, Week 6, Week 12, Week 24
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Change in Client Satisfaction with Treatment (CSQ) - R33
时间窗: Week 6, Week 12, Week 24
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
时间窗: Study Entry, Week 6, Week 12
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Change in Self-Reported Affect - R61
时间窗: Study Entry, Week 6, Week 12
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
时间窗: Study Entry, Week 6, Week 12
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Change in Client Satisfaction with Treatment (CSQ) - R61
时间窗: Week 6, Week 12
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
次要结局
未报告次要终点