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ASPIRE Cognitive Enhancement Study (ACES)

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ClinicalTrials.gov Identifier: NCT02657954
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2016
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Homelessness Mental Health Conditions Behavioral: CCT Behavioral: HCE Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Homeless OEF/OIF/OND Veterans
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Compensatory Cognitive Training (CCT)
Compensatory Cognitive Training
 Behavioral: CCT
10-week Compensatory Cognitive Training
Active Comparator: Holistic Cognitive Education (HCE)
Holistic Cognitive Education
 Behavioral: HCE
10-week Holistic Cognitive Education


Outcome Measures
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Primary Outcome Measures :
  1. Change in Global Deficit Score from Expanded MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: 5, 10, 15 weeks ]
    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

  2. Change in UCSD Performance-Based Skills Assessment-Brief (UPSA-B) [ Time Frame: 5, 10, 15 weeks ]
    Performance-based functional capacity in finance and communication


Secondary Outcome Measures :
  1. Change in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 [ Time Frame: 5, 10, 15 weeks ]
    Measure of level of disability


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657954


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Elizabeth W. Twamley, PhD VA San Diego Healthcare System, San Diego, CA
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02657954     History of Changes
Other Study ID Numbers: D1972-I
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Homeless persons
Veterans
Mental disorders
Cognition
Rehabilitation