NCT06656637

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Nov 2026

First Submitted

Initial submission to the registry

October 17, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 22, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

October 17, 2024

Last Update Submit

December 12, 2025

Conditions

Keywords

Prospective memoryMemory interventionMemory drillingVeteransMemory concernsCompensatory strategiesCognitive training

Outcome Measures

Primary Outcomes (3)

  • Prospective Memory Concerns Questionnaire (PMCQ)

    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.

    Day 10 of program, three month follow up

  • Adapted Royal Prince Alfred Prospective Memory Test

    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.

    three month follow up

  • Computerized Prospective Memory Assessment (C-PMAT)

    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.

    Day 10 of program, three month follow-up

Secondary Outcomes (3)

  • 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

Study Arms (3)

Memory Drilling BRAIN ITP (EXP)

EXPERIMENTAL

In the BRAIN ITP, the standard PM training for both the experimental (EXP) and control group (CON1), takes place during the patient's individual cognitive training sessions with the cognitive trainer. In total, there are seven sessions. At each of these sessions the cognitive trainer will review a new compensatory strategy for PM and assign a naturalistic PM practice task as homework to practice the strategy. The experimental group will receive the additional computerized "memory drills" training.

Standard of Care BRAIN ITP (CON1)

ACTIVE COMPARATOR

In the BRAIN ITP, the standard PM training for both the experimental (EXP) and control group (CON1), takes place during the patient's individual cognitive training sessions with the cognitive trainer. In total, there are seven sessions. At each of these sessions the cognitive trainer will review a new compensatory strategy for PM and assign a naturalistic PM practice task as homework to practice the strategy. The CON1 group will not receive the additional memory drilling.

Behavioral: Compensatory Strategies

Standard of Care PTSD ITP (CON2)

ACTIVE COMPARATOR

The PTSD ITP group (CON2) will receive the traditional standard of care (cognitive training and cognitive processing therapy). There is no spaced training or practice.

Behavioral: Compensatory StrategiesBehavioral: Cognitive Processing Therapy

Interventions

Memory DrillingBEHAVIORAL

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.

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.

Standard of Care BRAIN ITP (CON1)Standard of Care PTSD ITP (CON2)

This is PTSD-targeted therapy.

Standard of Care PTSD ITP (CON2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (11)

  • 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: 32842860BACKGROUND
  • 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: 14998733BACKGROUND
  • 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: 21108144BACKGROUND
  • 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: 34512292BACKGROUND
  • 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: 22433779BACKGROUND
  • 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: 35470369BACKGROUND
  • 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: 21971474BACKGROUND
  • 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: 29609519BACKGROUND
  • Pagulayan KF, Rau H, Madathil R, Werhane M, Millard SP, Petrie EC, Parmenter B, Peterson S, Sorg S, Hendrickson R, Mayer C, Meabon JS, Huber BR, Raskind M, Cook DG, Peskind ER. Retrospective and Prospective Memory Among OEF/OIF/OND Veterans With a Self-Reported History of Blast-Related mTBI. J Int Neuropsychol Soc. 2018 Apr;24(4):324-334. doi: 10.1017/S1355617717001217. Epub 2017 Dec 29.

    PMID: 29284552BACKGROUND
  • Palermo L, Cinelli MC, Piccardi L, De Felice S, Ciurli P, Incoccia C, Zompanti L, Guariglia C. Cognitive functions underlying prospective memory deficits: A study on traumatic brain injury. Appl Neuropsychol Adult. 2020 Mar-Apr;27(2):158-172. doi: 10.1080/23279095.2018.1501374. Epub 2018 Oct 31.

    PMID: 30380921BACKGROUND
  • Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.

    PMID: 24998488BACKGROUND

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Delany Thrasher, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Kevin Bickart, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neuropsychology, Health Sciences Assistant Clinical Professer

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 24, 2024

Study Start

October 22, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

UCLA Health Operation Mend is a comparably small treatment program; the program does not wish to share any IPD from research participants because their research participation is contingent on receiving treatment at the organization. No individual participant data will be shared.

Locations