Cognitive Stimulation Program in AIDS
December 9, 2013 updated by: University of Pittsburgh
Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Western Psychiatric Institute and Clinic, University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
Other Names:
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No Intervention: Control
These individuals will receive "usual care" during the 24 week follow-up period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Global Impairment Rating from battery of neuropsychological tests.
Time Frame: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change in perceived quality of life using MOS/HIV
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James T. Becker, Ph.D., University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
February 8, 2008
First Submitted That Met QC Criteria
February 20, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 9, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB1723
- R03MH081723-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.