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Completed

NCT Number: NCT00696839

Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

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

Primary outcomes

  1. Side effect symptoms measured by visual analogue scales

    Time frame: study start, 30 days, 60 days, 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • Milton S. Hershey Medical Center

Registry information

Official study title

Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2008
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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