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Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

This study has been completed.
Sponsor:
Collaborator:
Milton S. Hershey Medical Center
Information provided by:
Duquesne University
ClinicalTrials.gov Identifier:
NCT00696839
First received: June 11, 2008
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention
HIV Infections
Adverse Effects
 Behavioral: Cognitive-behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients

Resource links provided by NLM:

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

Further study details as provided by Duquesne University:

Primary Outcome Measures:
  • Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health status by SF-36 [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
  • Adherence by visual analogue scale [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
  • CD4 lymphocyte count [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]
  • Serum HIV level [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]
Enrollment: 29
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: R. Eric Doerfler, Duquesne University
ClinicalTrials.gov Identifier: NCT00696839     History of Changes
Other Study ID Numbers: #08-17
Study First Received: June 11, 2008
Last Updated: March 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Duquesne University:
Behavior Therapy
Anti-Retroviral Agents
Relaxation
Clinical Nursing Research
Complementary Therapies

ClinicalTrials.gov processed this record on March 03, 2015