Homelessness Clinical Trial
— ACESOfficial title:
Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans
NCT number | NCT02657954 |
Other study ID # | D1972-I |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | March 31, 2022 |
Verified date | February 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 | Measure of level of disability
WHODAS scores range from 0-100, higher scores are worse. For change in WHODAS scores, higher scores are also worse. |
baseline to 15 weeks |
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