ASPIRE Cognitive Enhancement Study
ACES
Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans
1 other identifier
interventional
79
1 country
1
Brief Summary
Cognitive impairments are present in up to 80% of homeless individuals, and may contribute to homelessness in Operation Enduring Freedom / Operation Iraqi Freedom / Operation New Dawn (OEF/OIF/OND) Veterans. The investigators propose to investigate these issues in homeless, treatment-seeking returning Veterans, who arguably face multiple potential barriers to recovery and reintegration, and with whom there is the greatest opportunity to prevent long-term homelessness. The investigators plan to conduct a 15-week randomized controlled trial of an evidence-based, 10-week Compensatory Cognitive Training (CCT) intervention vs. an education control condition to examine the effects of cognitive rehabilitation in this Veteran population. The investigators expect CCT-associated improvements in cognition and functional skills and generalization to reduced levels of disability, along with improved community reintegration outcomes. By attending to and treating cognitive impairments, the investigators can potentially prevent future homelessness and its negative health consequences, resulting in both healthcare cost savings and improved quality of life for Veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedResults Posted
Study results publicly available
December 12, 2023
CompletedJanuary 9, 2024
February 1, 2023
5.8 years
December 17, 2015
February 23, 2023
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB)
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 Global deficit score range = 0-5, lower scores are better, higher scores are worse. For change in global deficit score, higher is better.
baseline to 15 weeks
Change in UCSD Performance-Based Skills Assessment-Brief (UPSA-B)
Performance-based functional capacity in finance and communication UPSA scores range from 0-100, higher scores are better. For change in UPSA scores, higher is also better.
baseline to 15 weeks
Secondary Outcomes (1)
Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0
baseline to 15 weeks
Study Arms (2)
Compensatory Cognitive Training (CCT)
EXPERIMENTALCompensatory Cognitive Training
Holistic Cognitive Education (HCE)
ACTIVE COMPARATORHolistic Cognitive Education
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- Any race/ethnicity
- Age 18-55
- Receiving residential treatment at the VA San Diego Aspire Center
- Meets criteria for Aspire Center program entry
- OEF/OIF/OND Veteran
- Presence of at least one DSM-V mental health condition
- Does not meet criteria for substance use disorder for 28 days prior to admission
- Homeless or unstably housed
- Not a sex offender or violent offender
- Capable of performing activities of daily living and transfers
- Not judged by a clinician to be at current risk to self or others
- Has cognitive impairment in at least one cognitive domain (i.e., T-score \<40)
- Able to speak and read English
- Capable of and willing to provide signed informed consent
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
Related Publications (1)
Keller AV, Muller-Cohn CM, Austin TA, Jak AJ, Twamley EW. Neuropsychological functioning, neurobehavioral symptoms, and community reintegration in unstably housed veterans with mental health conditions. Clin Neuropsychol. 2023 Nov;37(8):1728-1744. doi: 10.1080/13854046.2023.2176364. Epub 2023 Feb 11.
PMID: 36772819DERIVED
MeSH Terms
Conditions
Interventions
Results Point of Contact
- Title
- Dr Elizabeth Twamley
- Organization
- VA San Diego Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth W. Twamley, PhD
VA San Diego Healthcare System, San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2015
First Posted
January 18, 2016
Study Start
July 1, 2016
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
January 9, 2024
Results First Posted
December 12, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share