Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations.

Pragmatic trials testing the effectiveness of interventions under "real world" conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial.

BACKGROUND: Manualized cognitive and behavioral therapies are increasingly used in primary care environments to improve nonpharmacological pain management. The Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) intervention, recently implemented by the Defense Health Agency for use across the military health system, is a modular, primary care-based treatment program delivered by behavioral health consultants integrated into primary care for patients experiencing chronic pain. Although early data suggest that this intervention improves functioning, it is unclear whether the benefits of BCBT-CP are sustained. The purpose of this paper is to describe the methods of a pragmatic clinical trial designed to test the effect of monthly telehealth booster contacts on treatment retention and long-term clinical outcomes for BCBT-CP treatment, as compared with BCBT-CP without a booster, in 716 Defense Health Agency beneficiaries with chronic pain. DESIGN: A randomized pragmatic clinical trial will be used to examine whether telehealth booster contacts improve outcomes associated with BCBT-CP treatments. Monthly booster contacts will reinforce BCBT-CP concepts and the home practice plan. Outcomes will be assessed 3, 6, 12, and 18 months after the first appointment for BCBT-CP. Focus groups will be conducted to assess the usability, perceived effectiveness, and helpfulness of the booster contacts. SUMMARY: Most individuals with chronic pain are managed in primary care, but few are offered biopsychosocial approaches to care. This pragmatic brief trial will test whether a pragmatic enhancement to routine clinical care, monthly booster contacts, results in sustained functional changes among patients with chronic pain receiving BCBT-CP in primary care.

Cognitive Behavioral Therapy for Veterans With Comorbid Posttraumatic Headache and Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial.

Importance: Posttraumatic headache is the most disabling complication of mild traumatic brain injury. Posttraumatic stress disorder (PTSD) symptoms are often comorbid with posttraumatic headache, and there are no established treatments for this comorbidity. Objective: To compare cognitive behavioral therapies (CBTs) for headache and PTSD with treatment per usual (TPU) for posttraumatic headache attributable to mild traumatic brain injury. Design, Setting, and Participants: This was a single-site, 3-parallel group, randomized clinical trial with outcomes at posttreatment, 3-month follow-up, and 6-month follow-up. Participants were enrolled from May 1, 2015, through May 30, 2019; data collection ended on October 10, 2019. Post-9/11 US combat veterans from multiple trauma centers were included in the study. Veterans had comorbid posttraumatic headache and PTSD symptoms. Data were analyzed from January 20, 2020, to February 2, 2022. Interventions: Patients were randomly assigned to 8 sessions of CBT for headache, 12 sessions of cognitive processing therapy for PTSD, or treatment per usual for headache. Main Outcomes and Measures: Co-primary outcomes were headache-related disability on the 6-Item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (PCL-5) assessed from treatment completion to 6 months posttreatment. Results: A total of 193 post-9/11 combat veterans (mean [SD] age, 39.7 [8.4] years; 167 male veterans [87%]) were included in the study and reported severe baseline headache-related disability (mean [SD] HIT-6 score, 65.8 [5.6] points) and severe PTSD symptoms (mean [SD] PCL-5 score, 48.4 [14.2] points). For the HIT-6, compared with usual care, patients receiving CBT for headache reported -3.4 (95% CI, -5.4 to -1.4; P < .01) points lower, and patients receiving cognitive processing therapy reported -1.4 (95% CI, -3.7 to 0.8; P = .21) points lower across aggregated posttreatment measurements. For the PCL-5, compared with usual care, patients receiving CBT for headache reported -6.5 (95% CI, -12.7 to -0.3; P = .04) points lower, and patients receiving cognitive processing therapy reported -8.9 (95% CI, -15.9 to -1.9; P = .01) points lower across aggregated posttreatment measurements. Adverse events were minimal and similar across treatment groups. Conclusions and Relevance: This randomized clinical trial demonstrated that CBT for headache was efficacious for disability associated with posttraumatic headache in veterans and provided clinically significant improvement in PTSD symptom severity. Cognitive processing therapy was efficacious for PTSD symptoms but not for headache disability. Trial Registration: ClinicalTrials.gov Identifier: NCT02419131.