IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
This study has been completed.
Sponsor:
Duquesne University
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: None (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:
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 ]
Secondary Outcome Measures:
- 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 ]
| 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:
|
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 (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
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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017