Cognitive Stimulation Program in AIDS

University of Pittsburgh

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Behavioral: Smartbrain

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00619567

R03MH081723-01 (U.S. NIH Grant/Contract)

SB1723

Details and patient eligibility

About

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.

Full 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)).

Enrollment: 60 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cognitive Stimulation

Experimental group

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.

Treatment:

Behavioral: Smartbrain

Control

No Intervention group

Description:

These individuals will receive "usual care" during the 24 week follow-up period.