Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design

BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients 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 brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in 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 both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT0114977

Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study

BACKGROUND: Patients with diabetes are at increased risk for depression, compounding the burden of disease. When comorbid with diabetes, depression leads to poorer health outcomes and often complicates diabetes self-management. Unfortunately, treatment options for these complex patients are limited and comprehensive services are rarely available for patients in rural settings. METHODS: A small open trial was conducted to test the acceptability, feasibility and preliminary outcomes of a telephone-delivered coaching intervention for rural-dwelling older adults with uncontrolled diabetes and comorbid, clinically significant depressive symptoms. A total of eight older adults were enrolled in Healthy Outcomes through Patient Empowerment (HOPE), a 10-session (12-week), telephone-based coaching intervention. Primary study constructs included measures of diabetes control (Hemoglobin [Hb] A1c), depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]), and diabetes-related distress (Problem Areas in Diabetes Scale [PAID]). Assessments were conducted at baseline, post-intervention, and 6-month follow-up. Acceptability and feasibility were evaluated using patient surveys, focused exit interviews, and session attendance data. RESULTS: Clinically significant improvements were realized post-intervention and at 6-month follow-up for outcomes related to diabetes and depression. Effect sizes using Cohen's d were determined post-intervention and at 6-month follow-up, respectively, for HbA1c (d=0.36; d=0.28), PHQ-9 (d=1.48; d=1.67, and PAID (d=1.50; d=1.06) scores. Among study participants, HbA1c improved from baseline by a mean (M) of 1.13 (SD=1.70) post-intervention and M=0.84 (SD=1.62) at 6 months. Depression scores, measured by the PHQ-9, improved from baseline by M=5.14 (SD=2.27) post-intervention and M=7.03 (SD=4.43) at 6-month follow-up. PAID scores also improved by M=17.68 (SD=10.7) post-intervention and M=20.42 (SD=20.66) from baseline to 6-month follow-up. Case examples are provided for additional context and to more fully articulate salient intervention concepts. CONCLUSION: Although preliminary, data from this small open trial suggest that HOPE holds the potential to improve both physical (diabetes) and emotional (diabetes distress, depression) health outcomes and that changes can be maintained over a 6-month time period. As envisioned by the authors, HOPE may function as an extension of traditional primary care for rural-dwelling older adults with multiple comorbidities. A future randomized clinical trial will test HOPE’s broader effectiveness with rural-dwelling older adults. TRIAL REGISTRATION: NCT0127471

Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness-implementation design

Abstract Background Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. Methods This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients 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 brief cognitive behavioral therapy adoption and fidelity. Conclusions Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in 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 both science and practice. Trial registration NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772</p