Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696839
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : March 2, 2010
Milton S. Hershey Medical Center
Information provided by:
Duquesne University

June 11, 2008
June 13, 2008
March 2, 2010
September 2008
June 2009   (Final data collection date for primary outcome measure)
Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ]
Same as current
Complete list of historical versions of study NCT00696839 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • HIV Infections
  • Adverse Effects
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
  • No Intervention: 1
    Usual care (adherence education)
  • Experimental: 2
    Usual care and Cognitive Behavioral Therapy sessions
    Intervention: Behavioral: Cognitive-behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
R. Eric Doerfler, Duquesne University
Duquesne University
Milton S. Hershey Medical Center
Principal Investigator: Eric Doerfler, PhD(c) Duquesne University School of Nursing
Duquesne University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP