Cognitive Stimulation Program in AIDS

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by University of Pittsburgh.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00619567

First received: February 8, 2008

Last updated: February 20, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2008

Last Updated Date

February 20, 2008

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00619567 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cognitive Stimulation Program in AIDS

Official Title ^ICMJE

Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS

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)).

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

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.

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00619567

Other Study ID Numbers ^ICMJE

SB1723, R03-MH081723-01

Has Data Monitoring Committee

Yes

Responsible Party

James T. Becker, University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

James T. Becker, Ph.D.

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

February 2008

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

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