HIV InfectionsNCT00696839
Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
A study testing Cognitive-behavioral therapy in people with HIV Infections and Adverse Effects, run by Duquesne University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Adverse Effects
- What is being tested?
- Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants currently taking antiretroviral medications for HIV
- Participants suffer from one or more: nausea, pain, fatigue, anxiety
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
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.
Read the 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.
- Conditions
- HIV Infections, Adverse Effects
- Being tested
- Cognitive-behavioral therapy
- Keywords
- Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Also called Relaxation techniques, Progressive muscle relaxation, Guided imagery, Reframing
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual care (adherence education) |
| 2 | Experimental | Usual care and Cognitive Behavioral Therapy sessions Receives: Behavioral: Cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effect symptoms measured by visual analogue scales
Measured: study start, 30 days, 60 days, 90 days
Secondary outcomes (4)
Health status by SF-36
Measured: study start, 30 days, 60 days, 90 days
Adherence by visual analogue scale
Measured: study start, 30 days, 60 days, 90 days
CD4 lymphocyte count
Measured: study start, 90 days
Serum HIV level
Measured: study start, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Investigators
- Eric Doerfler, PhD(c), Principal investigator, Duquesne University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696839
- Sponsor's protocol ID
- #08-17
- Status last verified
- Mar 2010
- First submitted
- 11 Jun 2008
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
- ClinicalTrials.gov ID
- NCT00696839
- Acronym / sponsor ID
- #08-17
- Conditions
- HIV Infections, Adverse Effects
- Keywords
- Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual care (adherence education) |
| 2 | Experimental | Behavioral: Cognitive-behavioral therapyUsual care and Cognitive Behavioral Therapy sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants currently taking antiretroviral medications for HIV
- Participants suffer from one or more: nausea, pain, fatigue, anxiety
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyAlso: Relaxation techniques, Progressive muscle relaxation, Guided imagery, Reframing3 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. | Behavioural | 2 |
Primary outcome
Side effect symptoms measured by visual analogue scales
Time frame: study start, 30 days, 60 days, 90 days
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Doerfler, PhD(c) principal investigator
Duquesne University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy in people with HIV Infections and Adverse Effects, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effect symptoms measured by visual analogue scales (time frame: study start, 30 days, 60 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.