Efficacy and Mechanisms of a Metacognitive Strategy Intervention for Parkinson Disease-Related Cognitive Decline.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Bangor Goal Setting Interview
研究概览
简要总结
Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem.
Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD.
Study participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.
详细描述
Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem. Therefore, behavioral interventions that attenuate its negative functional consequences and thus potentially delay dementia onset are a top research priority. Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD.
Specifically, the investigators use the Multicontext (MC) Approach to support daily cognitive function in people with PD with mild cognitive decline. The MC Approach is a metacognitive strategy intervention that targets awareness, strategy use, and self-efficacy to improve functional cognitive performance in daily life. Through therapist- mediated experiences with cognitively challenging functional activities, participants develop personalized strategies (e.g., self-talk, planning, checklists) to prevent or correct cognitive performance errors. The goal is to enable people to manage everyday cognitive challenges so they can perform and participate in meaningful activities and roles. In a development and proof-of-concept study, the investigators adapted and refined the treatment protocol and training materials, established good participant acceptance, and provided preliminary data on its benefits for daily cognitive function. In a subsequent pilot quasi-randomized controlled trial (R21AG063974), the investigators established trial feasibility and treatment fidelity and generated promising treatment effect data. Notably, the MC Approach produced clinically meaningful improvements in daily cognitive function that were larger than that of the cognitive task training control and that were maintained 3 and possibly 12 months post treatment. the investigators now have the experience, methods, and data to justify and prepare us for a full-scale efficacy trial.
The investigators will conduct a randomized controlled trial (RCT) to determine the short- and long-term efficacy of the MC Approach for improving daily cognitive function in people with PD with mild cognitive decline. Secondarily, the investigators will examine whether booster treatment enhances treatment effects and explore the cognitive-behavioral mechanisms of the MC Approach. PD participants (N=114) will complete baseline assessment, randomization to treatment group (MC n=76, Control n=38), 10 treatment sessions (1x/week), and 1 week, 3 months, and 6 months post treatment assessment. MC participants will then be randomized to a booster (MC+B n=38) or no-booster (MC n=38) condition, and the MC+B group will receive booster treatment within the following month. Then all three groups (Control, MC, MC+B) will complete 12-month assessment. Mixed model repeated measures analysis of variance will be used to compare change across treatment groups and over time.
Our primary study aims and hypotheses are:
Aim 1: Determine the effect of the MC Approach on daily cognitive function. H1: The MC group will report greater improvements in daily cognitive function than the Control group 1 week (H1a; short-term) and 12 months (H1b; long-term) post treatment. Participants will rate their performance on personalized functional cognitive goals using a standardized cognitive rehabilitation tool (primary outcome: Bangor Goal Setting Interview, (BGSI) at each testing timepoint. Primary analyses will include the 1-week and 12-month data for Control and MC participants; additional analyses can look at trajectories across all timepoints.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Males and females over age 50 who meet criteria for typical idiopathic PD.
- •Hoehn & Yahr stage I-III.
- •Have subjective cognitive decline (SCD) as defined by a positive answer to either question:
- •Do you feel like your thinking skills or memory are becoming worse or are worse than others your age?
- •Do you have problems or concerns with your thinking skills or memory?, and can list ≥1 daily cognitive challenge they want to address.
- •Medications should be stable for 4 weeks prior with no changes planned during the treatment portion of the study (Pre to Post); unplanned changes and changes over the follow-up period will be tracked and accounted for as appropriate.
排除标准
- •Dementia according to MDS criteria or MoCA score <
- •Other neurological disorders (e.g., stroke, seizures).
- •Current or history of major psychiatric disorder or psychotic symptoms (e.g., schizophrenia, bipolar disorder, delusions, hallucinations), drug abuse. Psychiatric conditions/symptoms that are common in PD (e.g., anxiety, depression) are permitted if deemed insufficient to interfere with participation.
- •Other circumstance that would interfere with participation (e.g., non-English speaking, blindness, lives >50mi away).
研究组 & 干预措施
Process Training
The Control Group cognitive process training
干预措施: Cognitive (Process) Training (Behavioral)
MC Approach
The experimental Multicontext Approach Intervention
干预措施: A metacognitive strategy for cognitive rehabilitation called the Multicontext Approach. (Behavioral)
MC + Booster
From the MC Approach group only, MC+Boster participants will receive 2 additional treatment sessions with their original OT within the month following their 6mo FU assessment.
干预措施: MC Approach Booster Session (Behavioral)
结局指标
主要结局
Bangor Goal Setting Interview
时间窗: Goals will be assessed during the intervention at 2- and 4-weeks after Baseline testing; at POST intervention 11-weeks after Baseline; then one year from the final intervention session (63-weeks after Baseline).
A standardized cognitive rehabilitation tool to identify functional cognitive problems and develop treatment goals. Participants rate their goal attainment on a scale from 0 (not successful) to 10 (very successful); readiness to work on the specific goal on a scale of 0 (not ready to change) to 10 (Extremely ready to change); and the importance of the goal to them on a scale from 0 (not important) to 10 (extremely important).
次要结局
- The Cognitive Self-Efficacy Questionnaire(Participants will complete this questionnaire at the Baseline session, then after the participant finishes the intervention sessions at 11-, 23-, 35- and 63-weeks after Baseline.)
- The Weekly Calendar Planning Activity(The weekly calendar planning activity is administered at treatment session 1 of the intervention (1 week after Baseline), then after the participant completes the intervention at 11- and 63-weeks after Baseline.)
- The Self-Regulation Skills Interview(Participants are interviewed with the SRSI at treatment session 1 of the intervention (1 week after Baseline) then 1-week post intervention (11 weeks after Baseline).)
研究者
Erin Foster
Associate Professor
Washington University School of Medicine