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Cognitive Stimulation Program in AIDS

NCT ID: NCT00619567

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-01-31

Brief Summary

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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

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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)).

Conditions

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HIV Infections

Keywords

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Cognition Rehabilitation Cognitive Stimulation Human Immunodeficiency Virus AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Smartbrain

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive stimulation

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James T. Becker, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Western Psychiatric Institute and Clinic, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R03MH081723-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SB1723

Identifier Type: -

Identifier Source: org_study_id