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

Primary Purpose

Mild Cognitive Impairment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules
Treatment As Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Cognitive Rehabilitation, Cognitive Training, Cognitive Remediation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ME-CCT Booster Training

Treatment as Usual

Arm Description

3-4 Sessions of ME-CCT Booster Training

Treatment as Usual

Outcomes

Primary Outcome Measures

"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.
"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.
"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.

Secondary Outcome Measures

Initial estimate of change in objective cognitive performance composite z score
Change in composite z score
Initial estimate of change in functional capacity performance composite z score
Change in composite z score

Full Information

First Posted
February 27, 2023
Last Updated
August 3, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05770479
Brief Title
Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans
Acronym
AID-CCT
Official Title
Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans (AID-CCT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Cognitive Rehabilitation, Cognitive Training, Cognitive Remediation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to treatment group assignment.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ME-CCT Booster Training
Arm Type
Experimental
Arm Description
3-4 Sessions of ME-CCT Booster Training
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Motivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster Modules
Other Intervention Name(s)
ME-CCT Booster
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
"Acceptability of Intervention Measure (AIM)" questionnaire mean score
Description
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.
Time Frame
4 weeks
Title
"Intervention Appropriateness Measure (IAM)" questionnaire mean score
Description
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.
Time Frame
4 weeks
Title
"Feasibility of Intervention Measure (FIM)" questionnaire mean score
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Initial estimate of change in objective cognitive performance composite z score
Description
Change in composite z score
Time Frame
baseline, 4 weeks
Title
Initial estimate of change in functional capacity performance composite z score
Description
Change in composite z score
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline E Maye, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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