Cognitive Stimulation Program in AIDS - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institute of Mental Health (NIMH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00619567

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Behavioral: Smartbrain	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Global Impairment Rating from battery of neuropsychological tests. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in perceived quality of life using MOS/HIV [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cognitive Stimulation: Experimental 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.	Behavioral: Smartbrain 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.
Control: No Intervention These individuals will receive "usual care" during the 24 week follow-up period.

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)).

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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, CNS Opportunistic Infections, CNS tumors, or stroke
History of learning disability or ADD/ADHD (by subject report).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619567

Locations

United States, Pennsylvania
Western Psychiatric Institute and Clinic, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

James T. Becker, Ph.D.

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh ( James T. Becker )
Study ID Numbers:	SB1723, R03-MH081723-01
Study First Received:	February 8, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00619567 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Cognition
Rehabilitation
Cognitive Stimulation
Human Immunodeficiency Virus
AIDS

Study placed in the following topic categories:

Virus Diseases
Methamphetamine
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Amphetamine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009