Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
Primary Purpose
HIV Infections, Adverse Effects
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies
Eligibility 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
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Usual care (adherence education)
Usual care and Cognitive Behavioral Therapy sessions
Outcomes
Primary Outcome Measures
Side effect symptoms measured by visual analogue scales
Secondary Outcome Measures
Health status by SF-36
Adherence by visual analogue scale
CD4 lymphocyte count
Serum HIV level
Full Information
NCT ID
NCT00696839
First Posted
June 11, 2008
Last Updated
March 1, 2010
Sponsor
Duquesne University
Collaborators
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00696839
Brief Title
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
Official Title
Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Duquesne University
Collaborators
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Adverse Effects
Keywords
Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Usual care (adherence education)
Arm Title
2
Arm Type
Experimental
Arm Description
Usual care and Cognitive Behavioral Therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Other Intervention Name(s)
Relaxation techniques, Progressive muscle relaxation, Guided imagery, Reframing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Side effect symptoms measured by visual analogue scales
Time Frame
study start, 30 days, 60 days, 90 days
Secondary Outcome Measure Information:
Title
Health status by SF-36
Time Frame
study start, 30 days, 60 days, 90 days
Title
Adherence by visual analogue scale
Time Frame
study start, 30 days, 60 days, 90 days
Title
CD4 lymphocyte count
Time Frame
study start, 90 days
Title
Serum HIV level
Time Frame
study start, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Doerfler, PhD(c)
Organizational Affiliation
Duquesne University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
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