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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 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 parti
• Другое 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.

Первичные конечные точки

• "Acceptability of Intervention Measure (AIM)" questionnaire mean score [Срок оценки: 4 weeks]
• "Intervention Appropriateness Measure (IAM)" questionnaire mean score [Срок оценки: 4 weeks]
• "Feasibility of Intervention Measure (FIM)" questionnaire mean score [Срок оценки: 4 weeks]

Вторичные конечные точки (2)

• Initial estimate of change in objective cognitive performance composite z score [Срок оценки: baseline, 4 weeks]
• Initial estimate of change in functional capacity performance composite z score [Срок оценки: baseline, 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• VA San Diego Healthcare System, San Diego, CA — San Diego

Идентификаторы

NCT: NCT05770479 · E3821-W · 1IK2RX003821-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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