Mild Cognitive ImpairmentAID-CCTNCT05770479
Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans
A study testing Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules and Treatment As Usual in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans have numerous risk factors (e.g., Post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), cerebrovascular problems) for later-life cognitive and functional decline. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
About this study
Official title: Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)
Veterans have numerous risk factors (e.g., Post-traumatic stress disorder (PTSD), traumatic brain injury (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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules, Treatment As Usual
- Keywords
- Mild Cognitive Impairment, Cognitive Rehabilitation, Cognitive Training, Cognitive Remediation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster ModulesBehavioural
Also called ME-CCT Booster
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 Mild Cognitive Impairment (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.
Treatment As UsualOther
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| ME-CCT Booster Training | Experimental | 3-4 Sessions of ME-CCT Booster Training Receives: Behavioral: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules |
| Treatment as Usual | Other | Treatment as Usual Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (2)
Initial estimate of change in objective cognitive performance composite z score
Change in composite z score
Measured: baseline, 4 weeks
Initial estimate of change in functional capacity performance composite z score
Change in composite z score
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jacqueline E Maye, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770479
- Sponsor's protocol ID
- E3821-W
- Other IDs
- 1IK2RX003821-01A1
- Acronym
- AID-CCT
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)
- ClinicalTrials.gov ID
- NCT05770479
- Acronym / sponsor ID
- AID-CCT / E3821-W
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Cognitive Rehabilitation, Cognitive Training, Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans have numerous risk factors (e.g., Post-traumatic stress disorder (PTSD), traumatic brain injury (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ME-CCT Booster Training | Experimental | Behavioral: Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules3-4 Sessions of ME-CCT Booster Training |
| Treatment as Usual | Other | Other: Treatment As UsualTreatment as Usual |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster ModulesAlso: ME-CCT BoosterME-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 Mild Cognitive Impairment (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. | Behavioural | ME-CCT Booster Training |
| Treatment As UsualAlso: TAUTreatment 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. | Other | Treatment as Usual |
Primary outcome
"Acceptability of Intervention Measure (AIM)" questionnaire mean score
Time frame: 4 weeks
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.
"Intervention Appropriateness Measure (IAM)" questionnaire mean score
Time frame: 4 weeks
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.
"Feasibility of Intervention Measure (FIM)" questionnaire mean score
Time frame: 4 weeks
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.
2 secondary outcomes
Initial estimate of change in objective cognitive performance composite z score
Time frame: baseline, 4 weeks
Initial estimate of change in functional capacity performance composite z score
Time frame: baseline, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacqueline E Maye, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules and Treatment As Usual in people with Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Acceptability of Intervention Measure (AIM)" questionnaire mean score (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.