Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Global Impairment Rating from battery of neuropsychological tests.
Study Overview
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)).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Exclusion Criteria
- Not provided
Arms & Interventions
Cognitive Stimulation
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.
Intervention: Smartbrain (Behavioral)
Control
These individuals will receive "usual care" during the 24 week follow-up period.
Outcomes
Primary Outcomes
Global Impairment Rating from battery of neuropsychological tests.
Time Frame: 24 weeks
Secondary Outcomes
- Change in perceived quality of life using MOS/HIV(24 weeks)