Clinical Trials Directory

Trials / Enrolling By Invitation

Enrolling By InvitationNCT05770479

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

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

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
55 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMotivationally-Enhanced Compensatory Cognitive Training (ME-CCT) Booster ModulesME-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.
OTHERTreatment As UsualTreatment 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.

Timeline

Start date
2023-07-01
Primary completion
2028-06-30
Completion
2028-06-30
First posted
2023-03-15
Last updated
2025-08-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05770479. Inclusion in this directory is not an endorsement.