Effectiveness of Coping Training for People With HIV Experiencing Treatment Side Effects (The Balance Project)
NCT ID: NCT00643903
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2004-04-30
2009-02-28
Brief Summary
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Detailed Description
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This study will involve two phases. Phase 1 will be conducted over 12 months and will include two 1-hour interviews with questions about personal life, family, friends, medications, and medication side effects. After the first interview, participants may be invited to participate in Phase 2, which will last 18 months.
During Phase 2, participants will complete five 2- to 3-hour interviews occurring at baseline and Months 3, 6, 12, and 18. Interviews will include questions about personal life, friends, family, health-related activities, drug-using behaviors, emotions, mental state, and educational background. Participants will be assigned randomly to one of two treatment groups:
* Group 1 participants will receive five individual sessions of cognitive behavioral coping training, beginning after the Month 3 interview. The 90-minute sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
* Group 2 participants will receive standard care and one group session of coping training, which will be held after the Month 18 interview. The group session will cover the same material that is covered in the individual sessions.
After the last follow-up interview, some participants may also be asked to complete an exit interview about thoughts and feelings on study participation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Participants will receive five individual sessions of coping effectiveness training.
Cognitive behavioral coping effectiveness training
Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
2
Participants will receive standard care and one delayed group workshop of coping effectiveness training.
Standard care
Participants will receive standard of care for HIV infections.
Single group workshop on coping effectiveness training
Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.
Interventions
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Cognitive behavioral coping effectiveness training
Coping effectiveness training will include five individual 90-minute counseling sessions. The sessions will focus on coping with stress, dealing with medication side effects, and staying on track with medications.
Standard care
Participants will receive standard of care for HIV infections.
Single group workshop on coping effectiveness training
Participants will attend one group workshop covering the same material as in the individual sessions. The workshop will be delivered after completion of the Month 18 final assessment.
Eligibility Criteria
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Inclusion Criteria
* Currently receiving ART
* Experiencing ART side effects
Exclusion Criteria
* Evidence of psychosis or cognitive impairment
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mallory O. Johnson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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