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Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)

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VA Office of Research and Development

Status

Invitation-only

Conditions

Mild Cognitive Impairment

Treatments

Other: Treatment As Usual
Behavioral: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05770479
E3821-W
1IK2RX003821-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

The RCT portion of this study is a pilot trial evaluating the feasibility and acceptability of a "booster" CCT intervention for individuals who have already previously participated in CCT. 28 Veterans who previously participated in the ME-CCT intervention group of the "Cognitive Rehabilitation for Older Veterans with Mild Cognitive Impairment" study [PI: Twamley, VA CSRD: I01CX001592] will be recruited to participate in this pilot RCT.

All participants will receive an initial assessment that consists of neuropsychological and functional capacity tests, and will complete several self-reports of quality of life and daily function. Participants will complete questionnaires focused on acceptability, appropriateness, and feasibility. Participants will then be randomized to pilot RCT booster training or Treatment as Usual (TAU) group, yielding approximately 14 participants in each group. Participants will receive either three to four booster intervention modules/sessions or treatment as usual. Directly following the approximately 4-week intervention window, all 28 participants will receive the same battery of tests and questionnaires they received at the beginning of the sub-study.

Although the investigators will attempt to estimate possible initial effects of the CCT booster on cognitive and functional outcomes, the purpose of this pilot RCT is to examine feasibility and acceptability, not to complete an adequately-powered efficacy study.

Enrollment

28 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

ME-CCT Booster Training
Experimental group
Description:
3-4 Sessions of ME-CCT Booster Training
Treatment:
Behavioral: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules
Treatment as Usual
Other group
Description:
Treatment as Usual
Treatment:
Other: Treatment As Usual

Trial contacts and locations

1

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Central trial contact

Elizabeth W Twamley, PhD; Jacqueline E Maye, PhD

Data sourced from clinicaltrials.gov

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