ASPIRE Cognitive Enhancement Study (ACES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657954|
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2016
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Homelessness Mental Health Conditions||Behavioral: CCT Behavioral: HCE||Not Applicable|
This study integrates cognitive rehabilitation in residential care for homeless Veterans. In a 15-week randomized controlled trial, the investigators will compare an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention to an education control condition for homeless Veterans with cognitive impairment. CCT aims to improve real-world cognitive performance by teaching strategies to improve prospective memory (remembering to do things), attention, learning/memory, and executive functioning. Strategies to reduce stress and improve sleep are also included. CCT has been shown to improve cognition, functional capacity, neurobehavioral symptom severity, and quality of life in individuals with cognitive impairment associated with psychiatric illness and in Veterans with traumatic brain injury (TBI). During the trial, assessments will be administered at baseline, 5 weeks, 10 weeks, and 15 weeks, and monthly follow-up phone calls will assess housing and employment/education status for one year following program discharge. The investigators expect CCT-associated improvements in cognition and functional skills (co-primary outcomes) and generalization to reduced levels of disability, along with improved community reintegration outcomes (better housing stability, participation in work or school, and healthcare appointment attendance). If effective, the CCT intervention could be exported to the 80+ residential VA programs serving homeless Veterans. The investigators thus propose the following aims:
Aim 1. Investigate the efficacy of cognitive rehabilitation in homeless returning Veterans with mental health conditions and cognitive impairment by conducting a randomized controlled trial of Compensatory Cognitive Training (CCT) vs. education control for 10 weeks, with a 5-week follow-up, followed by 1 year of monthly post-discharge follow-up phone calls to assess community reintegration outcomes.
H1a: Positive CCT-associated effects on cognition, functional capacity (co-primary outcomes), and disability will emerge over the 15-week study.
H1b: Positive CCT-associated effects on community reintegration outcomes (housing stability, participation in employment/education, healthcare appointment attendance) will be detected at the end of the 1-year follow-up.
Aim 2. Investigate mechanisms of CCT effects. H2: Improved cognition and cognitive strategy use will mediate improvements in functional capacity, disability, and community reintegration.
Exploratory Aim 3. Investigate moderators of CCT effects. Presence and severity of Posttraumatic Stress Disorder (PTSD), depression, history of substance abuse, and TBI, as well as duration of homelessness and baseline cognitive functioning, will be explored as potential moderators of CCT effects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans|
|Actual Study Start Date :||July 1, 2016|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Compensatory Cognitive Training (CCT)
Compensatory Cognitive Training
10-week Compensatory Cognitive Training
Active Comparator: Holistic Cognitive Education (HCE)
Holistic Cognitive Education
10-week Holistic Cognitive Education
- Change in Global Deficit Score from Expanded MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 5, 10, 15 weeks ]Global Deficit Score (composite score) from MATRICS Consensus Cognitive Battery plus Delis-Kaplan Executive Function System (D-KEFS) subtests (Verbal Fluency, Color-Word Interference), Trail Making Test, Part B
- Change in UCSD Performance-Based Skills Assessment-Brief (UPSA-B) [ Time Frame: 5, 10, 15 weeks ]Performance-based functional capacity in finance and communication
- Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 [ Time Frame: 5, 10, 15 weeks ]Measure of level of disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657954
|United States, California|
|VA San Diego Healthcare System, San Diego, CA|
|San Diego, California, United States, 92161|
|Principal Investigator:||Elizabeth W. Twamley, PhD||VA San Diego Healthcare System, San Diego, CA|