Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- "Acceptability of Intervention Measure (AIM)" questionnaire mean score
研究概览
简要总结
Veterans have numerous risk factors (e.g., Post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), cerebrovascular problems) for later-life cognitive and functional decline. Evidence supports the effectiveness of strategy-based cognitive rehabilitation therapies, including compensatory cognitive training (CCT), for such decline. However, questions remain about the length of time that CCT-driven improvements in cognitive and everyday function last, and whether additional 'booster' training sessions could provide additional benefit to aging Veterans who previously underwent treatment. This study examines the long-term durability of CCT in Veterans aged 55+ and provides an opportunity to develop and pilot test a series of CCT booster sessions that can be personalized toward individual everyday functional goals.
详细描述
The RCT portion of this study is a pilot trial evaluating the feasibility and acceptability of a "booster" CCT intervention for individuals who have already previously participated in CCT. 28 Veterans who previously participated in the ME-CCT intervention group of the "Cognitive Rehabilitation for Older Veterans with Mild Cognitive Impairment" study [PI: Twamley, VA CSRD: I01CX001592] will be recruited to participate in this pilot RCT.
All participants will receive an initial assessment that consists of neuropsychological and functional capacity tests, and will complete several self-reports of quality of life and daily function. Participants will complete questionnaires focused on acceptability, appropriateness, and feasibility. Participants will then be randomized to pilot RCT booster training or Treatment as Usual (TAU) group, yielding approximately 14 participants in each group. Participants will receive either three to four booster intervention modules/sessions or treatment as usual. Directly following the approximately 4-week intervention window, all 28 participants will receive the same battery of tests and questionnaires they received at the beginning of the sub-study.
Although the investigators will attempt to estimate possible initial effects of the CCT booster on cognitive and functional outcomes, the purpose of this pilot RCT is to examine feasibility and acceptability, not to complete an adequately-powered efficacy study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be blind to treatment group assignment.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans aged 55 and older who are able to provide informed consent
- •Previous completion of the "Cognitive Rehabilitation for Older Veterans with Mild Cognitive Impairment" [PI: Twamley, VA CSRD: I01CX001592] study and received the ME-CCT intervention
- •Independently living
- •English-speaking: this is necessary to complete cognitive and functional testing and participate in booster development and other study procedures
排除标准
- •Participation in sub-study 2 of this CDA, in which study participants assist with the design of booster intervention modules
- •DSM-5 criteria for current substance use disorder and has been substance abstinent for less than 30 days
- •History of schizophrenia, schizoaffective disorder, or other primary psychotic disorder
- •History of significant brain injury with loss of consciousness >30 minutes
- •Auditory or visual impairments that would prevent ability to participate in booster sessions or ability to benefit from compensatory strategies
研究组 & 干预措施
Treatment as Usual
Treatment as Usual
干预措施: Treatment As Usual (Other)
ME-CCT Booster Training
3-4 Sessions of ME-CCT Booster Training
干预措施: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules (Behavioral)
结局指标
主要结局
"Acceptability of Intervention Measure (AIM)" questionnaire mean score
时间窗: 4 weeks
Four-item measure of perceived intervention implementation acceptability from Weiner et al., (2017) that has demonstrated strong psychometric properties. On a scale of 1-5 (completely disagree to completely agree), participants are asked to respond to the following: 1) implementation strategy meets my approval 2) implementation strategy is appealing to me 3) I like the implementation strategy 4) I welcome the implementation strategy. Average score of these four questions is calculated for measure score. Mean of participants' measure scores will be reported.
"Intervention Appropriateness Measure (IAM)" questionnaire mean score
时间窗: 4 weeks
Four-item measure of perceived intervention implementation appropriateness from Weiner et al., (2017) that has demonstrated strong psychometric properties. On a scale of 1-5 (completely disagree to completely agree), participants are asked to respond to the following: 1) implementation strategy seems fitting 2) implementation strategy seems suitable 3) implementation strategy seems applicable 4) implementation strategy seems like a good match. Average score of these four questions is calculated for measure score. Mean of participants' measure scores will be reported.
"Feasibility of Intervention Measure (FIM)" questionnaire mean score
时间窗: 4 weeks
Four-item measure of perceived intervention implementation feasibility from Weiner et al., (2017) that has demonstrated strong psychometric properties. On a scale of 1-5 (completely disagree to completely agree), participants are asked to respond to the following: 1) implementation strategy seems implementable 2) implementation strategy seems possible 3) implementation strategy seems doable 4) implementation strategy seems easy to use. Average score of these four questions is calculated for measure score. Mean of participants' measure scores will be reported.
次要结局
- Initial estimate of change in objective cognitive performance composite z score(baseline, 4 weeks)
- Initial estimate of change in functional capacity performance composite z score(baseline, 4 weeks)