Background: While protocol-based psychological treatments have significantly advanced mental health care, real-world accessibility remains a challenge. Primary care, the main provider of mental health services, faces barriers such as limited resources and a diverse patient population with varying needs, making it difficult to rely solely on time-intensive, protocolized treatments. The Primary Care Behavioral Health (PCBH) model promotes brief, flexible interventions that may better accommodate these needs. However, limited research on these interventions raises concerns about potential undertreatment. To align with Universal Health Coverage principles, it is essential to identify which patient groups benefit most from resource-efficient protocol-based versus brief, flexible, and individualized treatments. Our main aim is to evaluate whether a integrating guided self-help into PCBH improves outcomes compared to the core PCBH model, as well as to assess whether patients identified as suitable for protocol-based interventions benefit more from the combined model.

Methods: Patients seeking help for mental or behavioral health problems at PCBH primary care centers will be randomized to one of two arms: core PCBH, where patients receive a contextual assessment and brief interventions tailored to their needs, or an extended PCBH model, where a diagnostic assessment determines whether patients receive brief interventions or guided self-help. The primary outcome is functional impairment, assessed at baseline and followed up at 4, 8, and 12 weeks (primary endpoint), as well as at 1 year. Secondary outcomes include symptom change, cost-effectiveness, and care process factors.

Discussion: The study design allows for comparisons of patient outcomes between the two care models, with a primary focus on evaluating superiority and a secondary focus on non-inferiority, cost-effectiveness, and care process factors. Overall, the project seeks to advance understanding of effective mental health interventions in primary care settings and inform decision-making regarding treatment approaches.

BackgroundProviding comprehensive and continuous care for patients whose conditions have mental or behavioral components is a central challenge in primary care and an important part of improving universal health coverage. There is a great need for high and routine availability of psychological interventions, but traditional methods for delivering psychotherapy often result in low reach and long wait times. Primary Care Behavioral Health (PCBH) is a method for organizing primary care in which behavioral health staff provide brief, flexible interventions to a large part of the population in active collaboration with other providers. While PCBH holds promise in addressing important challenges, it has not yet been thoroughly evaluated.MethodsThis cluster randomized trial will assess 17 primary care centers (PCCs) that are starting a PCBH implementation process. The PCCs will be divided into two groups, with one starting immediate implementation and the other acting as a control, implementing six months later. The purpose of the study is to strengthen the evidence base for PCBH regarding implementation-, organization-, and patient-level outcomes, taking into consideration that there is a partially dependent relationship between the three levels. Patient outcomes (such as increased daily functioning and reduction of symptoms) may be dependent on organizational changes (such as availability of treatment, waiting times and interprofessional teamwork), which in turn requires change in implementation outcomes (most notably, model fidelity). In addition to the main analysis, five secondary analyses will compare groups based on different combinations of randomization and time periods, specifically before and after each center achieves sufficient PCBH fidelity.DiscussionA randomized comparison of PCBH and traditional primary care has, to our knowledge, not been made before. While the naturalistic setting and the intricacies of implementation pose certain challenges, we have designed this study in an effort to evaluate the causal effects of PCBH despite these complex aspects. The results of this project will be helpful in guiding decisions on how to organize the delivery of behavioral interventions and psychological treatment within the context of primary care in Sweden and elsewhere.Trial registrationClinicalTrials.gov: NCT05335382. Retrospectively registered on March 13th, 2022.