RCT of Behavioral Activation for Depression and Suicidality in Primary Care

NIH RePORTER · VA · I01 · · view on reporter.nih.gov ↗

Abstract

DESCRIPTION (provided by applicant): 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...

Key facts

NIH application ID
9768223
Project number
5I01HX000909-05
Recipient
SYRACUSE VA MEDICAL CENTER
Principal Investigator
Jennifer S Funderburk
Activity code
I01
Funding institute
VA
Fiscal year
2020
Award amount
Award type
5
Project period
2015-03-01 → 2020-02-28