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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
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by:
Duquesne University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The hypothesis is that participants in the intervention group will experience fewer/less intense side effects from anti-HIV medications, if they receive training sessions on the use of guided imagery, relaxation, and reframing of the medication-taking experience. Such training is not part of the usual care of HIV patients.

Condition or disease Intervention/treatment Phase
HIV Infections Adverse Effects Behavioral: Cognitive-behavioral therapy Not Applicable

Detailed Description:
HIV patients on antiretroviral medications, who are suffering from pain, nausea, anxiety, or fatigue will be randomly assigned to either the usual care for an HIV patient, which is an educational program about the medications, or an intervention program, which includes both the educational program and three sessions with a psychologist. The sessions will help participants understand their concerns about the medications and will teach relaxation techniques and guided imagery to help participants reduce discomforts associated with the medications. All patients will continue to receive the usual care from their medical providers. The main measures are the measured frequency and intensity of the symptoms under study; secondary measures examine medication adherence, CD4 counts, and virus levels. Control measures include the number of doses of side effect medications taken in each group, and the number of relaxation/imagery sessions practiced privately by participants in the intervention group.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
Usual care (adherence education)
Experimental: 2
Usual care and Cognitive Behavioral Therapy sessions
 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:
  • Relaxation techniques
  • Progressive muscle relaxation
  • Guided imagery
  • Reframing


Outcome Measures
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Primary Outcome Measures :
  1. Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ]

Secondary Outcome Measures :
  1. Health status by SF-36 [ Time Frame: study start, 30 days, 60 days, 90 days ]
  2. Adherence by visual analogue scale [ Time Frame: study start, 30 days, 60 days, 90 days ]
  3. CD4 lymphocyte count [ Time Frame: study start, 90 days ]
  4. Serum HIV level [ Time Frame: study start, 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Duquesne University
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Eric Doerfler, PhD(c) Duquesne University School of Nursing
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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