Despite the availability of evidence-based psychotherapies for depression and anxiety, theyare underused in non-mental health specialty settings such as primary care. Hybrideffectiveness-implementation designs have the potential to evaluate clinical andimplementation outcomes of evidence-based psychotherapies to improve their translation intoroutine clinical care practices.
This protocol article discusses the study methodology and implementation strategiesemployed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims:(1) to determine whether a brief, manualized cognitive behavioral therapy administered byVeterans Affairs Primary Care Mental Health Integration program clinicians is effective intreating depression and anxiety in a sample of medically ill (chronic cardiopulmonarydiseases) primary care patients and (2) to examine the acceptability, feasibility, andpreliminary outcomes of a focused implementation strategy on improving adoption andfidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integrationclinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneouslytest clinical effectiveness and to collect pilot data on a multifaceted implementation strategythat includes an online training program, audit and feedback of session content, and internaland external facilitation. Additionally, the study engages the participation of an advisorycouncil consisting of stakeholders from Primary Care-Mental Health Integration, as well asregional and national mental health leaders within the Veterans Administration. It targetsrecruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) orusual care (n = 120). Both effectiveness and implementation outcomes are being assessedusing mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses acrossmultiple time points) and qualitative methods (e.g., focus interviews and surveys frompatients and providers). Patient-effectiveness outcomes include measures of depression,anxiety, and physical health functioning using blinded independent evaluators.Implementation outcomes include patient engagement and adherence and clinician briefcognitive behavioral therapy adoption and fidelity.
Hybrid designs are needed to advance clinical effectiveness and implementation knowledgeto improve healthcare practices. The current article describes the rationale and challengesassociated with the use of a hybrid design for the study of brief cognitive behavioral therapyin primary care. Although trade-offs exist between scientific control and external validity,hybrid designs are part of an emerging approach that has the potential to rapidly advance bothscience and practice.Trial registrationNCT01149772 at https://clinicaltrials.gov/study/NCT01149772