Cognitive Stimulation Program in AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619567
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : December 10, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Smartbrain Phase 1

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS
Study Start Date : September 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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.
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.
Other Name: Cognitive stimulation
No Intervention: Control
These individuals will receive "usual care" during the 24 week follow-up period.

Primary Outcome Measures :
  1. Global Impairment Rating from battery of neuropsychological tests. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change in perceived quality of life using MOS/HIV [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00619567

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)
Principal Investigator: James T. Becker, Ph.D. University of Pittsburgh

Responsible Party: University of Pittsburgh Identifier: NCT00619567     History of Changes
Other Study ID Numbers: SB1723
R03MH081723-01 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by University of Pittsburgh:
Cognitive Stimulation
Human Immunodeficiency Virus

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases