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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compensatory Cognitive Training (CCT) | Experimental | Compensatory Cognitive Training |
|
| Holistic Cognitive Education (HCE) | Active Comparator | Holistic Cognitive Education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCT | Behavioral | 10-week Compensatory Cognitive Training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth W. Twamley, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36772819 | Derived | 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. |
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79 participants were enrolled and randomized to a condition and were included in intent to treat analyses, but 10 dropped out before starting their assigned intervention (5 in each arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training |
| FG001 | Holistic Cognitive Education (HCE) | Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
79 participants enrolled and baseline tested; 10 did not receive intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training |
| BG001 | Holistic Cognitive Education (HCE) | Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed a baseline assessment (i.e., intent to treat sample) | Posted | Mean | Standard Deviation | score on a scale | baseline to 15 weeks |
|
Adverse events were monitored from baseline assessment to 12-months post-discharge. Study length was variable due to variability in time of treatment center discharge (study length was 1.5 years on average).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Compensatory Cognitive Training (CCT) | Compensatory Cognitive Training CCT: 10-week Compensatory Cognitive Training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elizabeth Twamley | VA San Diego Healthcare System | 858-642-3848 | elizabeth.twamley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2022 | Feb 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C007907 | HCE |
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| HCE |
| Behavioral |
10-week Holistic Cognitive Education |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education |
|
|
| 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. | All participants with baseline data included (i.e., intent to treat sample) | Posted | Mean | Standard Deviation | score on a scale | 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. | All participants with baseline data (i.e., intent to treat sample) | Posted | Mean | Standard Deviation | score on a scale | baseline to 15 weeks |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Holistic Cognitive Education (HCE) | Holistic Cognitive Education HCE: 10-week Holistic Cognitive Education | 0 | 40 | 0 | 40 | 0 | 40 |
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