Clinical trial NCT05770479: Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans
Official title: Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Cognitive Rehabilitation
Cognitive Training
Cognitive Remediation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-03-15
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: "Acceptability of Intervention Measure (AIM)" questionnaire mean score
timeFrame: 4 weeks
measure: "Intervention Appropriateness Measure (IAM)" questionnaire mean score
timeFrame: 4 weeks
measure: "Feasibility of Intervention Measure (FIM)" questionnaire mean score
timeFrame: 4 weeks
Secondary outcomes:
measure: Initial estimate of change in objective cognitive performance composite z score
timeFrame: baseline, 4 weeks
measure: Initial estimate of change in functional capacity performance composite z score
timeFrame: baseline, 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Jacqueline E Maye, PhD
role: PRINCIPAL_INVESTIGATOR
References: