To Drill or Not to Drill: Do Memory Drills Help Train the Ability to "Remember to Remember" in Veterans

Официальное название

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

Обзор

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.

Подробное описание

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).

Participants will be assessed at baseline (before entering the program), at exit (immediately after the two-week program) and at 3 months post exit. The assessments consist of surveys regarding their PM performance in their day-to-day lives, a computerized and naturalistic objective measurement of PM. All assessments, except for the exit assessment which does not include the naturalistic task, will be administered via Zoom by study staff. Participants will fill out the exit assessment by themselves. The total study time will be approximately 2 to 3.5 hours over the course of approximately 15 to 17 weeks.

Вмешательства

• Поведенческое Memory Drilling
  The experimental group will receive the additional intervention during their seven sessions with their care providers. The intervention is computerized "memory drills" training. This training includes the completion of a list learning memory task (HVLT) and then a PM practice task conducted on the computer at each session.
• Поведенческое Compensatory Strategies
  Participants learn compensatory strategies to assist with their memory performance. This involves both external strategies, such as calendering and setting alarms, and internal strategies, like imagery and mnemonics.
• Поведенческое Cognitive Processing Therapy
  This is PTSD-targeted therapy.

Первичные конечные точки

• Prospective Memory Concerns Questionnaire (PMCQ) [Срок оценки: Day 10 of program, three month follow up]
• Adapted Royal Prince Alfred Prospective Memory Test [Срок оценки: three month follow up]
• Computerized Prospective Memory Assessment (C-PMAT) [Срок оценки: Day 10 of program, three month follow-up]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, Los Angeles — Los Angeles

Публикации

• Wijenberg MLM, Hicks AJ, Downing MG, van Heugten CM, Stapert SZ, Ponsford JL. Relevance of the Fear-Avoidance Model for Chronic Disability after Traumatic Brain Injury. J Neurotrauma. 2020 Dec 15;37(24):2639-2646. doi: 10.1089/neu.2020.7135. Epub 2020 Sep 22. PMID 32842860
• Wells A, Cartwright-Hatton S. A short form of the metacognitions questionnaire: properties of the MCQ-30. Behav Res Ther. 2004 Apr;42(4):385-96. doi: 10.1016/S0005-7967(03)00147-5. PMID 14998733
• Radford KA, Lah S, Say MJ, Miller LA. Validation of a new measure of prospective memory: the Royal Prince Alfred Prospective Memory Test. Clin Neuropsychol. 2011 Jan;25(1):127-40. doi: 10.1080/13854046.2010.529463. Epub 2010 Nov 19. PMID 21108144
• Sugden N, Thomas M, Kiernan M, Wilesmith M. Validation of the Prospective Memory Concerns Questionnaire (PMCQ). Front Hum Neurosci. 2021 Aug 26;15:686850. doi: 10.3389/fnhum.2021.686850. eCollection 2021. PMID 34512292
• Mioni G, Stablum F, McClintock SM, Cantagallo A. Time-based prospective memory in severe traumatic brain injury patients: the involvement of executive functions and time perception. J Int Neuropsychol Soc. 2012 Jul;18(4):697-705. doi: 10.1017/S1355617712000306. Epub 2012 Mar 20. PMID 22433779
• Sheppard DP, Rau HK, Werhane ML, Fonseca LM, Chaytor NS, Peskind ER, Pagulayan KF. Associations between Intra-Individual Neurocognitive Variability and Prospective Memory in Veterans with Mild Traumatic Brain Injury History and Posttraumatic Stress Disorder. Arch Clin Neuropsychol. 2022 Aug 23;37(6):1221-1227. doi: 10.1093/arclin/acac014. PMID 35470369
• Rosen AC, Sugiura L, Kramer JH, Whitfield-Gabrieli S, Gabrieli JD. Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. J Alzheimers Dis. 2011;26 Suppl 3(Suppl 3):349-57. doi: 10.3233/JAD-2011-0009. PMID 21971474
• Raskin SA, Williams J, Aiken EM. A review of prospective memory in individuals with acquired brain injury. Clin Neuropsychol. 2018 Jul;32(5):891-921. doi: 10.1080/13854046.2018.1455898. Epub 2018 Apr 2. PMID 29609519

Идентификаторы

NCT: NCT06656637 · IRB-24-0693

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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