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
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Sep 2008
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMarch 2, 2010
March 1, 2010
9 months
June 11, 2008
March 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Side effect symptoms measured by visual analogue scales
study start, 30 days, 60 days, 90 days
Secondary Outcomes (4)
Health status by SF-36
study start, 30 days, 60 days, 90 days
Adherence by visual analogue scale
study start, 30 days, 60 days, 90 days
CD4 lymphocyte count
study start, 90 days
Serum HIV level
study start, 90 days
Study Arms (2)
1
NO INTERVENTIONUsual care (adherence education)
2
EXPERIMENTALUsual care and Cognitive Behavioral Therapy sessions
Interventions
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.
Eligibility Criteria
You may qualify if:
- Participants currently taking antiretroviral medications for HIV
- Participants suffer from one or more: nausea, pain, fatigue, anxiety
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duquesne Universitylead
- Milton S. Hershey Medical Centercollaborator
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Doerfler, PhD(c)
Duquesne University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 13, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2009
Study Completion
August 1, 2009
Last Updated
March 2, 2010
Record last verified: 2010-03