Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Subjective Cognitive Decline
研究概览
简要总结
Depression affects one-third of intensive care unit (ICU) survivors and represents a potentially modifiable target to slow cognitive decline and reduce the risk of Alzheimer's disease and related dementias (ADRD). Our multi-PI team proposes a two-arm RCT called ADEPT-ICU (Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU Survivors), which will test the efficacy of an internet CBT intervention called Good Days Ahead (GDA) to reduce the burden of subjective cognitive decline (SCD) in older ICU survivors with moderate to severe depressive symptoms after ICU hospitalization.
详细描述
Alzheimer's disease and related dementias (ADRD) affect 47 million people worldwide with an annual global cost of $818 billion. The risk of developing ADRD is disproportionately borne by older adults with multiple chronic conditions from underrepresented racial and ethnic groups (URGs). One such high risk group is older survivors of critical illness who were admitted to the intensive care units (ICUs). Nearly half of ICU survivors experience subjective cognitive decline(SCD), i.e., perceived decline in memory and thinking even with normal objective cognitive data. With over 5 million adult ICU admissions in the US each year, an intervention reducing SCD in older ICU survivors could significantly prevent or lower the incidence of ADRD. Thus, there is an urgent need for an inclusive randomized controlled trial (RCT) to rigorously test whether a novel, accessible, and scalable intervention can reduce SCD in a diverse cohort of older ICU survivors. One potential target for such interventions is post-ICU depression, which affects about one-third of ICU survivors. To date, there are no large scale RCTs which have rigorously tested whether depression focused psychotherapies, such as cognitive behavioral therapy (CBT), reduce SCD in a diverse cohort of older ICU survivors with depression.
We propose a two-arm, randomized, parallel-group, assessor-blinded clinical trial to evaluate the efficacy of internet CBT for depression compared to an active control in reducing SCD and slowing cognitive decline in older ICU survivors with post-ICU depression. The total duration of the intervention will be 6 months from randomization.
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 (Investigator, Outcomes Assessor)
盲法说明
The unblinded study coordinator is aware of randomization. The investigator and study team members responsible for the delivery of the intervention will be unblinded.
The study team staff performing outcomes assessments and the investigators overseeing this process will be blinded.
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Diagnosis of dementia or neurodegenerative disease (e.g. Alzheimer's disease, vascular dementia as per EHR and IQCODE, or Parkinson's disease) or on anti-dementia medications prior to ICU stay
- •Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
- •Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
- •Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
- •Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
- •Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
- •Uncorrected visual or auditory impairment including legal blindness or deaf
- •Status post tracheostomy and not able to communicate
- •Incarcerated or on parole after ICU stay
结局指标
主要结局
Subjective Cognitive Decline
时间窗: Measured at 6-month and 12-month follow-up.
The primary outcome will be subjective cognitive decline (SCD), measured using the Cognitive Change Index self-report version (CCI-SR).
次要结局
- Cognition status(Measured at 6-month and 12-month follow-up.)
- Quality of Life physical and mental component status(Measured at 6-month and 12-month follow-up.)
研究者
Babar Khan, MD, MS
Professor of Medicine
Indiana University
