ASPIRE Cognitive Enhancement Study
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/19/2019 |
| Start Date: | July 1, 2016 |
| End Date: | March 31, 2020 |
Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans
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.
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.
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.
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:
We found this trial at
1
site
San Diego, California 92161
Principal Investigator: Elizabeth W. Twamley, PhD
Phone: 858-642-3657
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