ASPIRE Cognitive Enhancement Study (ACES)

• ClinicalTrials.gov Identifier: NCT02657954
• Recruitment Status: Completed
• First Posted: January 18, 2016
• Last Update Posted: April 13, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 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
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: March 31, 2022

Arms and Interventions

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

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

• 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:

None.

Contacts and Locations

Locations

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

• Principal Investigator: Elizabeth W. Twamley, PhD; VA San Diego Healthcare System, San Diego, CA

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02657954
• Other Study ID Numbers: D1972-I
• First Posted: January 18, 2016
• Last Update Posted: April 13, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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