A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of patients that complete the study
研究概览
简要总结
The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions.
The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.
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
- Single (Care Provider)
盲法说明
Only the data collectors in this study will be blind to the patient's group allocation.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with one of the following: Mild Trauma Brain injury (TBI), Multiple Sclerosis (MS), Long COVID, or Mild Cognitive Impairment (MCI)
- •MCI patients age older than 50 years old, all other diagnosis 21-65 years old and are receiving care through the Michigan medicine network
- •Participants that can provide consent or legally authorized representative who can provide consent on their behalf
- •Cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
排除标准
- •TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
- •History of TBI (except for participants with TBI)
- •MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
- •MCI participants with disease duration greater than 1 year
- •Patients with other neurosensory or neurodegenerative diseases
- •Diagnosed with COVID-19 (except for Long COVID group)
- •Psychiatric disorders other than mild to moderate anxiety and depression
- •Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources and referred to patient's primary care provider
- •Diagnosed sleep disorders
- •Visual or auditory impairment,
- •Current or history of alcohol or substance abuse/dependence
- •Cognitive impairment less than 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
- •Cognitive impairment greater or equal to 1.0 standard deviation below the test score normed for age and education in 1 cognitive domain (verbal learning and memory, processing speed, or visuospatial memory)
- •Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy
结局指标
主要结局
Number of patients that complete the study
时间窗: week 8 (end of treatment)
Average number of sessions completed
时间窗: week 8 (end of treatment)
Overall experience based qualitative semi-structured interview
时间窗: Week 9 (after treatment ended)
This interview will be conducted at the end of the study and in the order of exit of participants to gather feedback about their satisfaction with the study. This brief interview consists of 3 questions that ask the participants to describe the aspects of the intervention participants found beneficial, willingness to participate again, and whether it was appropriate for participants needs. In addition, a brief quantitative satisfaction survey to rate overall satisfaction, how likely it would be recommend to others, and how satisfied participants are with telemedicine as a mode of delivery.
次要结局
- Brief Visuospatial Memory test (BVMT-R-25 minutes)(Week 9 (after treatment ended))
- California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)(Week 9 (after treatment ended))
- The Symbol Digit Modalities Test Score (SDMT-5 minutes)(Week 9 (after treatment ended))
- The Community Integration Questionnaire (CIQ) Score(Week 9 (after treatment ended))
- The Short Form Health Survey (SF-36)(Week 9 (after treatment ended))
- Montreal Cognitive Assessment (MoCA)(Week 9 (after treatment ended))
- The Memory Complaint Scale (MCS-2 minute) score(Week 9 (after treatment ended))
研究者
Hala Darwish
Associate Professor of Nursing
University of Michigan