Cognitive Stimulation Program in AIDS
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smartbrain
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Cognition, Rehabilitation, Cognitive Stimulation, Human Immunodeficiency Virus, AIDS
Eligibility Criteria
Inclusion Criteria:
- Access to the Internet (either from home or public access)
- Native language is English
- HIV infected
Exclusion Crieria:
- Active drug/alcohol abuse or dependence
- Current major depression
- History of neurological disease, Central Nervous System Opportunistic Infections, tumors, or stroke
- History of learning disability or Attention Deficit/Hyperactivity Disorder (by subject report).
Sites / Locations
- Western Psychiatric Institute and Clinic, University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Stimulation
Control
Arm Description
Subjects will be given Internet access to the Smartbrain cognitive stimulation program. They will complete exercises for ~30 minutes, at least three times per week, for a period of 24 weeks.
These individuals will receive "usual care" during the 24 week follow-up period.
Outcomes
Primary Outcome Measures
Global Impairment Rating from battery of neuropsychological tests.
Secondary Outcome Measures
Change in perceived quality of life using MOS/HIV
Full Information
NCT ID
NCT00619567
First Posted
February 8, 2008
Last Updated
December 9, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00619567
Brief Title
Cognitive Stimulation Program in AIDS
Official Title
Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There has been little success in treating the cognitive (thinking) problems associated with HIV/AIDS using medications. The purpose of this study is to determine whether an internet-based cognitive "stimulation" program might help HIV-infected individuals think more clearly. If this is true, then it means that people with mild forms of cognitive impairment may be able to help themselves to get better.
Detailed Description
The neurocognitive manifestations of HIV/AIDS have long been recognized as important for the management, survival, and quality of life of affected patients and their families. Following the advent of Highly active anti-retroviral therapy (HAART) the incidence of HIV-associated dementia (HAD) has fallen, but the prevalence of the milder forms of HIV-related cognitive disorders has risen. This is important because alterations in cognitive function can have significant impact on work and social activities, mood, and perceived quality of life. To date, pharmacological management of HIV-associated cognitive disorders - apart from HAART - have met with limited success (e.g., Peptide T, Ritalin). Therefore, it appears reasonable to ask whether the use of non-pharmacological tools might help alleviate or ameliorate the symptoms of the milder forms of cognitive impairment, and thus improve mood and activities of daily living. The purpose of this application is to request funds to allow us to complete a feasibility/pilot study of the merits of using an internet-based cognitive stimulation program (CSP) to improve the cognitive functions and quality of life of individuals with HIV/AIDS, and, secondarily, to detect such changes using a computerized assessment tool designed for use in a health care practitioner's office (Computer-Based Assessment of Mild Cognitive Impairment (CAMCI)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Cognition, Rehabilitation, Cognitive Stimulation, Human Immunodeficiency Virus, AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Stimulation
Arm Type
Experimental
Arm Description
Subjects will be given Internet access to the Smartbrain cognitive stimulation program. They will complete exercises for ~30 minutes, at least three times per week, for a period of 24 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These individuals will receive "usual care" during the 24 week follow-up period.
Intervention Type
Behavioral
Intervention Name(s)
Smartbrain
Other Intervention Name(s)
Cognitive stimulation
Intervention Description
The initial session will be set for 10 minutes, with weekly increases (of 10 minutes) to a maximum of 30 minutes per day, 7 days a week. Each subject will be trained using the same modules of the Smartbrain protocol, with an emphasis on speed of information processing.
Primary Outcome Measure Information:
Title
Global Impairment Rating from battery of neuropsychological tests.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in perceived quality of life using MOS/HIV
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Access to the Internet (either from home or public access)
Native language is English
HIV infected
Exclusion Crieria:
Active drug/alcohol abuse or dependence
Current major depression
History of neurological disease, Central Nervous System Opportunistic Infections, tumors, or stroke
History of learning disability or Attention Deficit/Hyperactivity Disorder (by subject report).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T. Becker, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
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Cognitive Stimulation Program in AIDS
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