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

Mild Cognitive Impairment Clinical Trial

— AID-CCT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05770479
• Other study ID #: E3821-W
• Secondary ID: 1IK2RX003821-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 28
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Other:
• Treatment As Usual
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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	"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
Primary	"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	Initial estimate of change in objective cognitive performance composite z score	Change in composite z score	baseline, 4 weeks
Secondary	Initial estimate of change in functional capacity performance composite z score	Change in composite z score	baseline, 4 weeks