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临床试验/NCT06656637
NCT06656637Enrolling By Invitation不适用

To Drill or Not to Drill: Do Memory Drills Help Strengthen Prospective Memory and Decrease Veterans' Concerns About Prospective Memory Problems?

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
75
试验地点
2
主要终点
Prospective Memory Concerns Questionnaire (PMCQ)

研究概览

简要总结

The goal of this clinical trial is to memory drilling works in improving the ability to remember to do something later in treatment-seeking veterans. The main question it aims to answer is:

Does adding memory drilling to intensive treatment programs improve the patient's ability to remember to do something later?

Researchers will compare typical standardized memory training to the memory training with drilling to see if drilling improves the veterans' ability to remember tasks they are supposed to do later.

Participants will:

  • complete the Operation Mend intensive treatment program with either standard care (either with or without Post-Traumatic Stress Disorder [PTSD] focused trauma therapy) or standard care + memory drilling
  • complete a virtual memory assessment at entrance, exit, and three months post exit. This assessment will include questionnaires, interviews, and computerized and naturalistic memory tasks.

详细描述

Treatment-seeking veterans who come for diagnostics and/or treatment to University of California, Los Angeles (UCLA) Operation Mend show a high level of memory concern. To address this issue, the veterans receive training in evidence-informed compensatory strategies. However, a high level of memory concern remains, and this study aims to investigate the efficacy of adding memory drills to the treatment program.

There is mixed evidence in the literature about whether memory drills, which tend to show improvement in computerized cognitive tasks, generalize to naturalistic forms of memory. Specifically, the efficacy of computerized training for prospective memory (PM), perhaps the most naturalistic form of memory, is understudied. The proposed study seeks to answer the question whether adding a computerized "drilling" of retrospective and prospective memory to Operation Mend's Cognitive Training enhances patients' PM performance & reduces their memory concerns.

Study participants will be only be recruited from participants of the Operation Mend Intensive Treatment Programs (ITPs). The BRAIN ITP is a two-week intensive brain health program for patients who may have a history of mild traumatic brain injury and other comorbidities who wish to focus on improving their day-to-day cognitive functioning, maximizing their brain health as well as reducing the impact of other symptoms such as physical pain. It involves cognitive training sessions and meetings with neuropsychologists, neurologists, occupational therapists, dieticians, etc. The PTSD ITP is a two-week intensive therapy and skills training program for patients who wish to focus on evidence-based treatment for PTSD and other psychological and cognitive comorbidities that involves mental health sessions and meetings with psychiatrists, psychologists, neuropsychologists, etc.

This will be a randomized controlled trial with three groups. The experimental group with BRAIN ITP participants will receive the normal standard of care and memory drilling while the BRAIN ITP control group receives only the normal standard of care. The third control group will come from the PTSD ITP who receive normal standard of care plus PTSD treatment. This control group is included because of indications of a connection between PTSD symptomology and PM deficits.

In the BRAIN ITP, the standard PM training for both the experimental and control group takes place during the patient's individual sessions with a neuropsychologist. In total, there are seven sessions. At each of these sessions the neuropsychologist will review a new compensatory strategy for prospective memory and assign a naturalistic task for completion as homework to practice the strategy. The experimental group will receive the additional "memory drills" training. This training includes the completion of a list learning memory task and then a prospective memory task conducted on the computer at each session. The PTSD ITP group will receive the standard of care (cognitive processing therapy and cognitive training).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Only patients that are already accepted and scheduled to participate in an Operation Mend BRAIN Intensive Treatment Program and PTSD Intensive Treatment Program are eligible to participate in the study.

排除标准

  • Patients with acute substance abuse disorders are not accepted into Operation Mend programs and are therefore excluded from the study.
  • For logistical reasons, patients who are scheduled for arrival at the ITP sooner than 2.5 or 3 weeks are not eligible to participate.
  • Patients who do not have tablet, iPad, or computer access are not eligible to participate due to the technical requirements of the computer-based assessments

结局指标

主要结局

Prospective Memory Concerns Questionnaire (PMCQ)

时间窗: Day 10 of program, three month follow up

The Prospective Memory Concerns Questionnaire (PMCQ) is a self-report that includes 3 subscales (Forgetting Behaviors, Memory Concerns, Retrieval Failures) and an event-based prospective memory task where they have to remember to write their handedness in the textbox at the end of the questionnaire. It is meant to assess participants experience with prospective memory tasks in their day to day lives. Item scores range from 0 to 3. Total score Range 0 to 105. Higher scores indicate more prospective memory concerns.

Adapted Royal Prince Alfred Prospective Memory Test

时间窗: three month follow up

This is a slightly adapted version (ie. using emails instead of posting letters, etc.) of the Royal Prince Alfred Prospective Memory Assessment. It is a lab based but still naturalistic assessment of prospective memory. It involves short term and long term, time and event based prospective memory tasks. Total score range 0 to 12. Higher scores indicate better prospective memory performance.

Computerized Prospective Memory Assessment (C-PMAT)

时间窗: Day 10 of program, three month follow-up

This is a two-part computerized task that will take no more than 25 minutes total. There are two components to the task: the "ongoing" task and the embedded prospective memory task. The ongoing task will be the same for both parts of the task - a letter 2 back. The first part of the task will involve an event-based prospective memory response while the second part will require a time-based prospective memory response. For the event-based part, participants are told to press the letter "N" itself, instead of the "2 back" button of the ongoing task, when the letter "N" is on the screen. In the time-based part, participants will be told to check the time every 100 seconds while completing the ongoing task. There will be 5 total embedded prospective tasks in each part. Total score range is 0 to 10. Higher scores indicate better performance.

次要结局

  • Metacognitive Prospective Memory Inventory (MPMI-s)(three month follow-up)
  • Cognitive Confidence subscale of MCQ-30(three month follow-up)
  • Post-concussive Catastrophizing Scale - cognitive symptoms (PCS-CS)(Day 10 of program, three month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Delany Thrasher

Director of Neuropsychology, Health Sciences Assistant Clinical Professer

University of California, Los Angeles

研究点 (2)

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