Cognitive Stimulation Program in AIDS

NCT00619567 | Completed Phase 1 DMC

• 2 other identifiers: SB1723R03MH081723-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Cognition; Rehabilitation; Cognitive Stimulation; Human Immunodeficiency Virus; AIDS

Outcome Measures

Primary Outcomes (1)

• Global Impairment Rating from battery of neuropsychological tests.

  24 weeks

Secondary Outcomes (1)

• Change in perceived quality of life using MOS/HIV

  24 weeks

Study Arms (2)

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

Control

NO INTERVENTION

These individuals will receive "usual care" during the 24 week follow-up period.

Interventions

Smartbrain BEHAVIORAL

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.

Also known as: Cognitive stimulation

Cognitive Stimulation

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Access to the Internet (either from home or public access)
• Native language is English
• HIV infected
• 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).

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• James T. Becker, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

US (1)