Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
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ClinicalTrials.gov Identifier: NCT00696839 |
Recruitment Status
:
Completed
First Posted
: June 13, 2008
Last Update Posted
: March 2, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Adverse Effects | Behavioral: Cognitive-behavioral therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1
Usual care (adherence education)
|
|
Experimental: 2
Usual care and Cognitive Behavioral Therapy sessions
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Behavioral: Cognitive-behavioral therapy
3 sessions of CBT: introduction of CBT, training in relaxation and guided imagery, and troubleshooting/closure. 50 minute sessions with an HIV-experienced treating psychologist in Beck-type CBT. Participants will be given an audiorecording of the 2nd session to be used in private home practice, as desired.
Other Names:
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- Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ]
- Health status by SF-36 [ Time Frame: study start, 30 days, 60 days, 90 days ]
- Adherence by visual analogue scale [ Time Frame: study start, 30 days, 60 days, 90 days ]
- CD4 lymphocyte count [ Time Frame: study start, 90 days ]
- Serum HIV level [ Time Frame: study start, 90 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants currently taking antiretroviral medications for HIV
- Participants suffer from one or more: nausea, pain, fatigue, anxiety
Exclusion Criteria:
- Non-English speaking/reading
- Pregnant or planning to become pregnant within 3 months
- Any severe health problem that would prevent participation (e.g., opportunistic infection requiring hospitalization)
- Substance abuse preventing active participation in care

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696839
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Eric Doerfler, PhD(c) | Duquesne University School of Nursing |
Responsible Party: | R. Eric Doerfler, Duquesne University |
ClinicalTrials.gov Identifier: | NCT00696839 History of Changes |
Other Study ID Numbers: |
#08-17 |
First Posted: | June 13, 2008 Key Record Dates |
Last Update Posted: | March 2, 2010 |
Last Verified: | March 2010 |
Keywords provided by Duquesne University:
Behavior Therapy Anti-Retroviral Agents Relaxation Clinical Nursing Research Complementary Therapies |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |