EXCEED THE SPACE PROVIDED. Introduction: This is an amended application to develop a cognitive-behavioral therapy for HIV medication adherence and major depression. It was first submitted as a (K23) and was positively reviewed; however, the reviewers suggested that the investigator reformulate it into an independent (non-mentored) proposal. Due to the stage of treatment development, it was then submitted as an R21. The reviews of the R21 were very encouraging, but the project did not achieve a fundable score. All of the new concerns of the review committee, however, have been addressed, substantially improving the overall strength of the project. Background: Depression is prevalent in HIV and is associated with poor self-care behaviors including poor adherence to antiretroviral medications. Patients with HIV and depression are at risk for poor health outcomes and possibly increased morbidity. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression. Overview of project goals and conceptual model of intervention: The main goal of this project is to complete NIH-detined stage 1activities in developing a cognitive behavioral intervention for depression and ART medication adherence. We propose to estimate the effect size of the intervention on improved depression, improved adherence to medications, and improved health status as defined by a clinically significant reduction in HIV viral load. Following the goals of the R21 mechanism, this will allow for the collection of the necessary pilot data to conduct a full-scale intervention study. We hypothesize that the psychosocial intervention will achieve improved health status in two ways: by directly increasing adherence to antiretroviral medications using the adherence skills-training, and by treating the depression which otherwise makes it difficult for patients to acquire or use these adherence skills. Overview of research plan: Patients with a detectable viral load who have a diagnosis of major depressive disorder will be randomized into either: (1) 'CBT,' the combination of CBT for depression and HIV medication adherence or (2)'Enhanced Clinical Management,' a single-session adherence intervention (Safren et al., 1999, 2001). Those who are assigned to Enhanced Clinical Management will be re-assigned to CBT after the acute phase of the study (4 months) if they have not improved on key outcome variables. Eligibility requirements at this stage of treatment development were selected to maximize the chances of finding an effect with a circumscribed sample (and minimizing the possibility of a type-II error). This will allow for an adequate power analysis for a full-scale intervention trial. PERFORMANCE SITE ========================================Section End===========================================

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21MH066660-03
Application #
6818767
Study Section
Special Emphasis Panel (ZRG1-AARR-8 (01))
Program Officer
Stirratt, Michael J
Project Start
2002-12-01
Project End
2006-11-30
Budget Start
2004-12-01
Budget End
2006-11-30
Support Year
3
Fiscal Year
2005
Total Cost
$168,125
Indirect Cost
Name
Fenway Community Health Center
Department
Type
DUNS #
072366156
City
Boston
State
MA
Country
United States
Zip Code
02215
Safren, Steven A; O'Cleirigh, Conall; Tan, Judy Y et al. (2009) A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol 28:1-10
Gonzalez, J S; Safren, S A; Delahanty, L M et al. (2008) Symptoms of depression prospectively predict poorer self-care in patients with Type 2 diabetes. Diabet Med 25:1102-7
Berg, Michael B; Mimiaga, Matthew J; Safren, Steven A (2008) Mental health concerns of gay and bisexual men seeking mental health services. J Homosex 54:293-306
Olatunji, Bunmi O; Mimiaga, Matthew J; O'Cleirigh, Conall et al. (2006) Review of treatment studies of depression in HIV. Top HIV Med 14:112-24
O'Cleirigh, Conall; Safren, Steven A (2006) Domains of life satisfaction among patients living with HIV: A factor analytic study of the quality of life inventory. AIDS Behav 10:53-8
Berg, M B; Safren, S A; Mimiaga, M J et al. (2005) Nonadherence to medical appointments is associated with increased plasma HIV RNA and decreased CD4 cell counts in a community-based HIV primary care clinic. AIDS Care 17:902-7
Berg, Michael B; Mimiaga, Matthew J; Safren, Steven A (2004) Mental health concerns of HIV-infected gay and bisexual men seeking mental health services: an observational study. AIDS Patient Care STDS 18:635-43