N/A
N=79
ASPIRE Cognitive Enhancement Study
Homelessness · Mental Health Conditions
Bottom Line
View on ClinicalTrials.gov: NCT02657954 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB) — 0.26; .14 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CCT (Behavioral); HCE (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Deficit Score From Expanded MATRICS Consensus Cognitive Battery (MCCB) |
0.26; .14 | — |
| PRIMARY Change in UCSD Performance-Based Skills Assessment-Brief (UPSA-B) |
8.3; 8.3 | — |
| SECONDARY Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 |
-5.6; -4.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
None.
Data sourced from ClinicalTrials.gov (NCT02657954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.