Cognitive Stimulation Program in AIDS

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619567
• Other study ID #: SB1723
• Secondary ID: R03MH081723-01
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2008
• Last updated: December 9, 2013
• Start date: September 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic, University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Impairment Rating from battery of neuropsychological tests.		24 weeks	No
Secondary	Change in perceived quality of life using MOS/HIV		24 weeks	No