Cognitive Stimulation Program in AIDS

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00619567
First received: February 8, 2008
Last updated: December 9, 2013
Last verified: December 2013

February 8, 2008
December 9, 2013
September 2007
January 2010   (final data collection date for primary outcome measure)
Global Impairment Rating from battery of neuropsychological tests. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00619567 on ClinicalTrials.gov Archive Site
Change in perceived quality of life using MOS/HIV [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Stimulation Program in AIDS
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.

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)).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
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
  • 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.
    Intervention: Behavioral: Smartbrain
  • No Intervention: Control
    These individuals will receive "usual care" during the 24 week follow-up period.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
January 2010   (final data collection date for primary outcome measure)

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).
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619567
SB1723, R03MH081723-01
Yes
University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: James T. Becker, Ph.D. University of Pittsburgh
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP