Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

HIV Infections Clinical Trial

Official title:

Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696839
• Other study ID #: #08-17
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: March 1, 2010
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2010
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. Such training is not part of the usual care of HIV patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adverse Effects
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effect symptoms measured by visual analogue scales		study start, 30 days, 60 days, 90 days	No
Secondary	Health status by SF-36		study start, 30 days, 60 days, 90 days	No
Secondary	Adherence by visual analogue scale		study start, 30 days, 60 days, 90 days	No
Secondary	CD4 lymphocyte count		study start, 90 days	No
Secondary	Serum HIV level		study start, 90 days	No