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

Not Applicable

• Conditions: Memory Deficit

• Registration Number: NCT06656637
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-17
• Study Start: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prospective Memory Concerns Questionnaire (PMCQ)	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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Metacognitive Prospective Memory Inventory (MPMI-s)	three month follow-up	This self-report questionnaire assesses the use of internal and external strategies to assist with memory. It will be used to assess whether the treatment program increased the use of compensatory strategies for prospective memory tasks.; Total score ranges from 22 - 110. Higher scores reflect better PM abilities.
Cognitive Confidence subscale of MCQ-30	three month follow-up	This is a 6-item self report subscale that assesses the patient's confidence/trust in their memory abilities. It will be used to assess patients belief in their memory abilities before and after the program. Total score ranges from 6 to 24. Higher scores indicate worse confidence.
Post-concussive Catastrophizing Scale - cognitive symptoms (PCS-CS)	Day 10 of program, three month follow-up	This measure is the post concussive catastrophizing scale with a focus on only cognitive symptoms. This will be used to assess if there is a change in the catastrophizing of cognitive abilities in the veteran pre and post treatment. Total score ranges from 0 to 52. Higher scores indicate higher catastrophizing.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States