Cognitive Stimulation Program in AIDS

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Smartbrain

• Registration Number: NCT00619567
• Lead Sponsor: University of Pittsburgh

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)).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-21
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Stimulation	Smartbrain	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.

Primary Outcome Measures

Name	Time	Method
Global Impairment Rating from battery of neuropsychological tests.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in perceived quality of life using MOS/HIV	24 weeks

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic, University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States