Depression Clinical Trial
Official title:
Efficacy of CBT for Adherence and Depression in HIV Care Settings
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
People infected with HIV are more likely to suffer from depression than those not infected,
with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant
depressive symptoms. Depression, in addition to causing persistent sadness and inability to
feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making
sure to take every pill as prescribed by doctors) is critically important to successful
treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to
develop immunity to the medication. Poor adherence is related to worse medical outcomes, but
even a small, 10% improvement rate in adherence may improve these outcomes. This study will
test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and
treatment adherence for HIV-infected people.
Participation in this study will last 1 year, including follow-up visits. All participants
will complete an initial one-visit intervention addressing treatment adherence. Then after 2
weeks, participants will be randomly assigned to one of three conditions: CBT for HIV
medication adherence and depression (CBT-AD), information and supportive psychotherapy for
HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU).
Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and
will be asked to report any changes to their psychological or HIV treatments. CBT-AD will
involve learning to identify and change problematic patterns of thought and behavior, while
ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will
receive only the initial session on HIV medication adherence and will be asked about their
psychological and HIV treatment every other week for 4 months.
Major study assessments will take place at baseline and after 4, 8, and 12 months.
Assessments will include completing diagnostic interviews and questionnaires, measuring
medication adherence through an electronic pill cap, and determining CD4 cell count and
viral load (indicators of HIV treatment effectiveness).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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