Depression is associated with considerable morbidity, mortality and quality of life decrements including social functioning, sleep impairment, cardiovascular events, and suicidal thoughts/behaviors. Depressive symptoms are the most common referral problem to integrated mental health providers. Although there exist several empirically-based brief psychotherapies for depression in primary care, the most significant barrier to providing those psychotherapies is treatment duration (e.g., the treatments range from 6-8 sessions of 30-50 minutes) as it does not meet the typical format of treatment conducted by mental health providers working in primary care (i.e., 1-4 15-30 minute sessions). Because 82% of VA primary care clinics have integrated mental health providers in primary care, it is vital that evidence-based behavioral interventions be identified that can be applied with Veterans reporting the full-range of depressive symptoms within these settings. Recent data show that mental health providers working in these settings report using elements of BA as one of the most common clinical interventions used when meeting with Veterans reporting depressive symptoms. Although the traditional 12-20 session format of BA has been found to be an efficacious treatment for Veterans reporting severe depressive symptomatology, the effectiveness of a 4-session manualized BA (BA-PC) on depression severity and/or specific depressive symptoms has not been evaluated. The overarching objectives are to examine: 1) whether a 4-session manualized BA-PC compared to Treatment as Usual (TAU) is effective in reducing features of depression, including self-reported depressive symptoms and other subjective secondary outcomes: sleep impairment and quality of life outcomes; 2) examine patient satisfaction, engagement, and receptivity to a 4-session BA-PC; and 3) to explore the impact of BA-PC on suicidal ideation (SI). The proposed study is a randomized, controlled trial with two conditions (4-session BA-PC and TAU), using an intent to treat design. Veterans will be recruited from three VA primary care settings in the Western portion of VISN 2 (Syracuse, Rochester, and Buffalo). The primary inclusion criteria for the study will be a report of depressive symptoms on the Patient Health Questionnaire-9 (PHQ-9) with a total score > 10, such Veterans who are not currently engaged in psychological treatment for depression will be asked to participate. Based on a power analysis, a total of 136 Veterans will be targeted for randomization. These Veterans will be grouped on (i) depression severity (mild to moderate vs. severe based on their PHQ-9 scores) and (ii) absence/presence of suicidal ideation and randomly assigned to receive the 4-session BA-PC or TAU. A TAU control condition was chosen because 1) a TAU condition is recommended when testing a modified treatment within a clinical setting and 2) to optimally inform VA training efforts to manage depression in primary care it is important to demonstrate that a 4-session BA-PC can reduce features of depression relative to TAU. All Veterans will be assessed every 2 weeks for changes in mood and more comprehensive assessments will be completed at 6, 12, and 24 weeks. After descriptive and simple statistics are conducted to describe the population and determine any differences among conditions, sites, and patient subgroups (e.g., declined), multi-level modeling will primarily be used to examine the aims. MLM provides a way to examine these relationships while handling incomplete data without resorting to listwise deletion of participants.
The availability of brief evidence-based therapies that can be efficiently delivered in primary care settings could significantly enhance care of ~29% of Veterans in primary care, those endorsing moderate to severe depressive symptoms1,2,3. Testing a 4-session manualized primary-care based, behavioral activation intervention (BA-PC) will help to establish the effectiveness of brief BA intervention suited to primary care, while also providing a 4-session model for providers to follow. To the extent that BA-BC improves other associated features of depression, such as sleep and quality of life outcomes, it may significantly reduce health consequences and service utilization for these Veterans. Given the interrelationship between depressive symptoms and suicidal thoughts/behaviors and the need for identified interventions for Veterans reporting suicidal thoughts/behaviors in primary care, this study may identify a potentially useful intervention to reduce suicide risk.
