Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans

NCT05770479 | Enrolling By Invitation

• 2 other identifiers: E3821-W1IK2RX003821-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans have numerous risk factors (e.g., PTSD, 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Cognitive Rehabilitation; Cognitive Training; Cognitive Remediation

Outcome Measures

Primary Outcomes (3)

• "Acceptability of Intervention Measure (AIM)" questionnaire mean score

  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.

  4 weeks

• "Intervention Appropriateness Measure (IAM)" questionnaire mean score

  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.

  4 weeks

• "Feasibility of Intervention Measure (FIM)" questionnaire mean score

  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.

  4 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

ME-CCT Booster Training

EXPERIMENTAL

3-4 Sessions of ME-CCT Booster Training

Behavioral: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules

Treatment as Usual

OTHER

Treatment as Usual

Other: Treatment As Usual

Interventions

Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules BEHAVIORAL

ME-CCT is a traditionally a manualized group-based behavioral intervention (8 weeks, 2 hours per week) designed to improve cognitive and everyday functioning in patients with MCI. Our booster modules will be shortened and distilled from ME-CCT using the IM Adapt protocol (and thus will not be new information but rather 'reminder' content) for a personalized four-session sequence of booster training targeted toward specific everyday functional needs of individual participants.

Also known as: ME-CCT Booster

ME-CCT Booster Training

Treatment As Usual OTHER

Treatment for MCI is generally managed by Primary Care or Neurology. Participants will continue to receive their usual care with their current providers. With no effective pharmacological treatment known for persons with MCI, providers tend to focus on encouraging a healthy lifestyle, prevention and management of modifiable risk factors for cognitive impairment, and treatment of behavioral and psychiatric symptoms.

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jacqueline E Maye, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to treatment group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two group randomized controlled trial

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 15, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)