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Depression Care Managers - new study
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"We report the results of a randomized trial to test the effect of measurement-based care (MBC) - a decision support model for antidepressant management integrated into HIV care, on HIV and mental health outcomes among HIV-infected adults with depression....A total of 304 participants were randomized to intervention (n=149) or usual care (n=155) (Fig. 1).
The majority of participants were aged 30-55 years, men, black non-Hispanic, and unemployed (Table 1). Participants had high depressive severity and prevalence of psychiatric comorbidities. Participants had strong HIV clinical indicators and high self-reported antiretroviral adherence. There were small differences between arms in certain demographic characteristics, but the arms were well balanced on baseline physical and mental health measures.
Treatment
Intervention participants had a mean of 8.9 DCM contacts (Table 2). At study enrollment, 44% of intervention and 40% of usual care participants were already on an antidepressant; 17% of intervention and 21% of usual care participants were on a moderate/high antidepressant dose (as defined previously based on standard dosing guidelines; [30,53]). Antidepressant prescription and moderate/high dosing increased in both arms during the study, but more rapidly and substantially in the intervention arm. External mental health referrals and nonstudy treatment sessions were similar between arms.
Results: From 2010 to 2013, 149 participants were randomized to intervention and 155 to usual care. Participants were mostly men, Black, non-Hispanic, unemployed, and virally suppressed with high baseline self-reported antiretroviral adherence and depressive severity. Over follow-up, no differences between arms in antiretroviral adherence or other HIV outcomes were apparent. At 6 months, depressive severity was lower among intervention participants than usual care [mean difference -3.7, 95% confidence interval (CI) -5.6, -1.7], probability of depression remission was higher [risk difference 13%, 95% CI 1%, 25%),and suicidal ideation was lower (risk difference -18%, 95% CI -30%, -6%). By 12 months, the arms had comparable mental health outcomes. Intervention arm participants experienced an average of 29 (95% CI: 1-57) more depression-free days over 12 months.
Conclusion: In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved clinically significant depression improvements and increased depression-free days. MBC may be an effective, resource-efficient approach to reducing depression morbidity among HIV patients.
The present study represents the largest trial to date of a collaborative care antidepressant management intervention integrated into HIV primary care, and the first such trial to our knowledge outside of the Veterans Administration system. The MBC depression management approach was effectively integrated in four HIV clinics, with high uptake of antidepressants and timely dose escalation in the intervention arm. No differences between arms were observed in the primary outcome - antiretroviral adherence - or other HIV outcomes, including HIV symptoms, viral load, or appointment adherence. At 6 months, relative to usual care, the intervention had reduced depressive severity by a clinically meaningful margin, increased depression remission, reduced suicidality, and improved mental health-related functioning. By 12 months, the usual care arm had caught up on most mental health outcome measures. However, by shortening the course of depressive episodes, the intervention conferred nearly an additional month of DFDs over the 12 months of study participation."
Depression is highly prevalent among people living with HIV [57,58]. Despite the known efficacy of depression treatments in this population [15,16], depression remains widely underdiagnosed and untreated or under treated in HIV primary care [17,18]. New care models that build on the success of collaborative depression treatment, in general primary care [59], are critically needed to address the large mental health treatment gap among people living with HIV. Models such as MBC efficiently leverage clinic staff time to provide antidepressant prescription decision support to HIV medical providers. This trial demonstrates that such a real-world strategy can significantly shorten the course of depressive illness for HIV patients and reduce overall morbidity from depression."
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The effect of antidepressant treatment on HIV and depression outcomes: the SLAM DUNC randomized trial.
AIDS July 4 2015
Pence, Brian W.; Gaynes, Bradley N.; Adams, Julie L.; Thielman, Nathan M.; Heine, Amy D.; Mugavero, Michael J.; Mcguinness, Teena; Raper, James L.; Willig, James H.; Shirey, Kristen G.; Ogle, Michelle; Turner, Elizabeth L.; Quinlivan, E. Byrd
Abstract
Background: Depression is a major barrier to HIV treatment outcomes.
Objective: To test whether antidepressant management decision support integrated into HIV care improves antiretroviral adherence and depression morbidity.
Design: Pseudo-cluster randomized trial.
Setting: Four US infectious diseases clinics.
Participants: HIV-infected adults with major depressive disorder.
Intervention: Measurement-based care (MBC) - depression care managers used systematic metrics to give HIV primary-care clinicians standardized antidepressant treatment recommendations.
Measurements: Primary - antiretroviral medication adherence (monthly unannounced telephone-based pill counts for 12 months). Primary time-point - 6 months. Secondary - depressive severity, depression remission, depression-free days, measured quarterly for 12 months.
Results: From 2010 to 2013, 149 participants were randomized to intervention and 155 to usual care. Participants were mostly men, Black, non-Hispanic, unemployed, and virally suppressed with high baseline self-reported antiretroviral adherence and depressive severity. Over follow-up, no differences between arms in antiretroviral adherence or other HIV outcomes were apparent. At 6 months, depressive severity was lower among intervention participants than usual care [mean difference -3.7, 95% confidence interval (CI) -5.6, -1.7], probability of depression remission was higher [risk difference 13%, 95% CI 1%, 25%),and suicidal ideation was lower (risk difference -18%, 95% CI -30%, -6%). By 12 months, the arms had comparable mental health outcomes. Intervention arm participants experienced an average of 29 (95% CI: 1-57) more depression-free days over 12 months.
Conclusion: In the largest trial of its kind among HIV-infected adults, MBC did not improve HIV outcomes, possibly because of high baseline adherence, but achieved clinically significant depression improvements and increased depression-free days. MBC may be an effective, resource-efficient approach to reducing depression morbidity among HIV patients.
Discussion
The present study represents the largest trial to date of a collaborative care antidepressant management intervention integrated into HIV primary care, and the first such trial to our knowledge outside of the Veterans Administration system.
The MBC depression management approach was effectively integrated in four HIV clinics, with high uptake of antidepressants and timely dose escalation in the intervention arm. No differences between arms were observed in the primary outcome - antiretroviral adherence - or other HIV outcomes, including HIV symptoms, viral load, or appointment adherence. At 6 months, relative to usual care, the intervention had reduced depressive severity by a clinically meaningful margin, increased depression remission, reduced suicidality, and improved mental health-related functioning. By 12 months, the usual care arm had caught up on most mental health outcome measures. However, by shortening the course of depressive episodes, the intervention conferred nearly an additional month of DFDs over the 12 months of study participation.
Similar to this study, two other randomized trials of antidepressant-focused depression treatment strategies reported substantial improvements in mental health measures, but no effect on HIV-related measures. A trial of directly observed weekly fluoxetine compared to referral to standard mental health services among 137 homeless or marginally housed men in San Francisco reported a strong effect of the intervention on depression outcomes, but no statistically significant differences in HIV outcomes [24]. A trial of collaborative care for depression relative to usual care among 249 patients at three Veterans Administration HIV clinics found a mental health benefit of the intervention at 6 months, but usual care participants had caught up by 12 months. The intervention lowered HIV symptoms, but had no effect on antiretroviral adherence or other HIV outcomes [25]. In contrast, three trials of cognitive behavioral therapy for depression with integrated adherence counseling (CBT-AD) have shown improvements in both depression and adherence among 45 adults with HIV and depression [22]; 89 adults with HIV, depression, and injection drug
use histories [54]; and 40 Latino adults with HIV and depression [55].
Two differences in the above studies are apparent. First, the three trials that identified an effect of depression treatment on antiretroviral adherence [22,54,55] were conducted among participants with relatively poor adherence or viral suppression at baseline. In contrast, participants in the present study and the two trials that did not identify such effects [24,25] had high baseline levels of adherence and rates of viral suppression, potentially introducing a ceiling effect on HIV outcomes. Second, the trials that found effects on adherence deployed an intervention that explicitly targeted both depression and adherence through counseling and/or reminder components, whereas the present study and the trials that did not find such effects primarily targeted depression through medication management.
In contrast to the mixed trial results, most observational studies have reported a positive association between depression treatment and antiretroviral adherence. A meta-analysis of 29 studies encompassing more than 12 000 individuals estimated that depression treatment improved the odds of satisfactory antiretroviral adherence by 83%, with a stronger association among observational than experimental studies [20]. Estimates from observational studies may be confounded by characteristics that are difficult to measure. For example, among depressed patients, those willing to initiate depression treatment may be more compliant with medical treatment in general. It is also possible that trials tend to enroll generally compliant patients whose adherence has little room to improve, whereas observational studies are able to include patients with a wider distribution of adherence.
Among this study's strengths are its size, multiple sites, duration of follow-up, objective adherence measure, rigorous pseudo-cluster randomization design, and high level of fidelity to protocol achieved through weekly supervision. An additional strength is the broad inclusion criteria. While many depression treatment trials exclude individuals with anxiety or substance use disorders to achieve a 'clean' participant pool, this study did not, since such a set of participants would bear little resemblance to patients with depression in real-world HIV care [56]. Similarly, many adherence trials restrict enrollment to individuals with low adherence or viral failure, but this study did not, since we sought to estimate the impact of a clinic-wide collaborative depression care intervention on HIV outcomes.
A major challenge for this study was missing data. While 77% of participants completed at least one follow-up, 60% had a valid 6-month primary outcome measure. Some of those lost may have discontinued antiretroviral therapy (ART); this is unknown. Importantly, missingness was balanced between arms, and sophisticated missing-data correction methods had little impact on effect estimates. Loss to follow-up could also be related to clinical comorbidities such as immune reconstitution inflammation syndrome (IRIS), although most participants were on stable ART at entry, no instances of IRIS were documented during follow-up, and correction for baseline clinical status did not substantively change effect estimates.
An additional limitation is the possibility that contamination may have diluted the true effect size, even with the pseudo-cluster design. While there were large differences in antidepressant prescription and dose escalation between the arms, these measures did improve somewhat among usual care participants over time, suggesting that some of the mental health gains of the usual care group by 12 months could be explained by contamination. Alternatively, this convergence could simply reflect the episodic nature of depressive disorders, for which treatment shortens the course of illness, but up to 50% of episodes resolve spontaneously within a year [13].
Depression is highly prevalent among people living with HIV [57,58]. Despite the known efficacy of depression treatments in this population [15,16], depression remains widely underdiagnosed and untreated or under treated in HIV primary care [17,18]. New care models that build on the success of collaborative depression treatment, in general primary care [59], are critically needed to address the large mental health treatment gap among people living with HIV. Models such as MBC efficiently leverage clinic staff time to provide antidepressant prescription decision support to HIV medical providers. This trial demonstrates that such a real-world strategy can significantly shorten the course of depressive illness for HIV patients and reduce overall morbidity from depression.
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