Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial: A protocol for a pragmatic comparative effectiveness trial with baseline results.

BACKGROUND: There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments. METHOD: Patients screening positive for PTSD (n = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5). RESULTS: Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline. CONCLUSION: Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.

Bipolar Disorder Symptom Monitoring Measures: A Mixed-Methods Study of Patient Preferences.

OBJECTIVE: To determine the perceived acceptability and helpfulness of bipolar disorder symptom measures and rank the measures in order of preference among individuals with bipolar disorder. METHODS: We recruited 20 participants 18 years of age or older with any type of bipolar disorder from a primary care clinical site and a national advocacy organization. We used a simultaneous complementary mixed-method design involving completion of symptom measures, a semistructured interview, and numerical ranking of measures. Participants completed three symptom measures or combination of measures: 1) Affective Self-Rating Scale; 2) combination Patient Mania Questionnaire-9 (PMQ-9) and Patient Health Questionnaire-9 (PHQ-9); and 3) combination Altman Self-Rating Mania Rating Scale and PHQ-9. A semistructured interview was conducted, and participants ranked their preferences for measures. Interviews focused on participants' rationale for measuring preferences. Interviews were analyzed by two psychiatrist-investigators using content analysis, and themes were determined. Average rank of each measure was determined. RESULTS: The average rank for each measure was 1.48 for the combination PMQ-9 and PHQ-9, 1.68 for the Affective Self-Rating Scale, and 2.85 for the combination Altman Self-Rating Mania Rating Scale and PHQ-9, indicating that the combination PMQ-9 and PHQ-9 (top-ranked measure by 55% of participants) was the most preferred among the three measures. Major themes that emerged from the data were: 1) measure format; 2) patient experience; 3) clinical practice; and 4) therapeutic effects. CONCLUSIONS: Individuals with bipolar disorder preferred the combination PMQ-9 and PHQ-9 for use in monitoring treatment due to perceived strengths such as format, ease of completion and interpretation, accurate description of experiences, and feasibility of use in practice.

Effectiveness of Collaborative Care and Colocated Specialty Care for Bipolar Disorder in Primary Care: A Secondary Analysis of a Randomized Clinical Trial.

BACKGROUND: Individuals with bipolar disorder commonly present for treatment in primary care settings. Collaborative care and colocated specialty care models can improve quality of care and outcomes, though it is unknown which model is more effective. OBJECTIVE: To compare 12-month treatment outcomes for primary care patients with bipolar disorder randomized to treatment with collaborative care or colocated specialty care. METHODS: We conducted a secondary analysis of 191 patients diagnosed with bipolar disorder treated for 12 months during a comparative effectiveness trial in 12 Federally Qualified Health Centers in three states. Characteristics and outcomes were assessed at enrollment and 12 months. The primary outcome was mental health quality of life scores (Veterans RAND 12-Item Health Survey Mental Health Component Summary), and secondary outcomes included depression and anxiety symptom scores, euthymic mood state, and recovery. T-tests and multiple linear and logistic regression models were used. RESULTS: Among participants (mean age: 40 years; 73% women), the Veterans RAND 12-Item Health Survey Mental Health Component Summary increased in both arms over 12 months (baseline: collaborative care 21.99, SD 10.78; colocated specialty 24.15, SD 12.05; 12-month collaborative care 30.63, SD 13.33; colocated specialty 34.16, SD 12.65). The mean Mental Health Component Summary change did not differ by arm (collaborative care: MΔ = 9.09; colocated specialty: MΔ = 10.73; t = -0.67, P = 0.50). Secondary outcomes also improved at 12 months compared to baseline measured by the Hopkins Symptoms Checklist (MΔ = -0.75; SD = 0.85), Generalized Anxiety Disorder-7 (MΔ = -3.92; SD = 6.48), and Recovery Assessment Scale (MΔ = 0.37; SD = 0.65) and did not differ significantly by arm. The proportion of participants with euthymic mood state increased from 11% to 25% with no statistically significant difference by arm. CONCLUSIONS: The effectiveness of collaborative care and that of colocated specialty care were similar. Both were associated with substantial improvements in mental health quality of life and symptom reduction.

JACLP Guide for Manuscript Peer Review: How to Perform a Peer Review and How to Be Responsive to Reviewer Comments.

Recognizing that very few potential reviewers and authors receive formal training on peer review, we provide guidance on peer reviewing manuscripts and on being responsive to reviewer comments. Peer review provides benefits to all parties involved. Serving as a peer reviewer gives perspective on the editorial process, fosters relationships with journal editors, gives insights into novel research, and provides a means of demonstrating topical expertise. When responding to peer reviewers, authors have the opportunity to strengthen the manuscript, sharpen the message, and address areas of potential misunderstanding. First, we provide guidance on how to peer review a manuscript. Reviewers should consider the importance of the manuscript, its rigor, and clarity of presentation. Reviewer comments should be as specific as possible. They should also be constructive and respectful in tone. Reviews typically include a list of major comments focused on methodology and interpretation and may also include a list of minor comments that pinpoint specific areas of clarification. Opinions expressed as comments to the editor are confidential. Second, we provide guidance on being responsive to reviewer comments. Authors are encouraged to approach reviewer comments as a collaboration and to view this exercise as an opportunity to strengthen their work. Response comments should be presented respectfully and systematically. The author's goal is to signal that they have engaged directly and thoughtfully with each comment. In general, when an author has questions regarding reviewer comments or how to respond, they are invited to contact the editor to review.

Bipolar disorder in primary care: Medication treatment by co-located psychiatrists versus primary care clinicians supported by psychiatrists.

OBJECTIVE: To compare medication treatment of individuals with bipolar disorder in two primary care-based integrated care models. METHODS: Participants were randomized to 12-months of treatment with direct care by co-located psychiatrists in primary care, or collaborative care (primary care clinicians supported by psychiatrists). Medication data at initial and last treatment visits were extracted from the clinical registry for 191 patients diagnosed with bipolar disorder. RESULTS: Participants receiving no medication treatment decreased from 28% to 11% (direct co-located) (χ2 = 10.9, p < .001) and 39% to 17% (collaborative care; χ2 = 16.9, p < .001). Last visit medication prescriptions for antipsychotic medication (approximately one-half of participants) increased significantly compared to initial visit and did not differ between arms. Anticonvulsant mood-stabilizing medication (approximately one-third of participants in both arms) was higher than lithium prescription (approximately 6% of participants) at last visit. CONCLUSION: Similar patterns of medication treatment were observed in participants with bipolar disorder receiving either direct care from psychiatrists, or medication treatment by primary care clinicians supported by psychiatrists.

Remote Collaborative Care With Off-Site Behavioral Health Care Managers: A Systematic Review of Clinical Trials.

BACKGROUND: In the United States, most patients who require behavioral health care do not receive it owing to an overall shortage of behavioral health specialists. The Collaborative Care Model (CoCM) is a team-based, highly-coordinated approach to treating common mental health conditions in primary care that has a robust evidence base. Several recent randomized controlled trials have demonstrated the effectiveness of remote CoCM teams. As telehealth technology advances and uptake expands, understanding the evidence for remote CoCM becomes increasingly crucial to inform CoCM practice and implementation. OBJECTIVE: The objective of this study was to systematically review randomized controlled trials regarding the effectiveness of remote CoCM teams in treating common psychiatric conditions in primary care and medical settings. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were used to structure our review. Our search strategy and development of search terms was informed by knowledge and review of the CoCM literature. Articles were reviewed by 3 authors, and once selected, they were sent to 2 authors for further data extraction to describe various study characteristics and process measures relating to remote CoCM. RESULTS: The literature search identified 13,211 articles, 9 of which met inclusion criteria. The 9 studies collectively demonstrate effectiveness of remote CoCM in treating a range of behavioral health conditions (depression [n = 7], anxiety [n = 2], and PTSD [n = 1]), across various populations and settings. Sample sizes ranged from 191 patients to 704 patients, publication dates from 2004 to 2018, and studies were conducted from 2000 to 2014. Various process measures were also reported. CONCLUSIONS: As the 9 studies included in our systematic review demonstrate, remote CoCM can be effective in treating a range of behavioral health conditions in various primary care and specialty medical settings. These findings suggest organizations may have more flexibility in building their CoCM team and drawing upon wider workforces than previously recognized. As recent shifts in telehealth policy and practice continue to motivate telehealth approaches, further research that can inform best practices for remote CoCM will be useful and valuable to those making organizational decisions when implementing integrated care models.

The Patient Mania Questionnaire (PMQ-9): a Brief Scale for Assessing and Monitoring Manic Symptoms.

BACKGROUND: Measurement-based care is an effective clinical strategy underutilized for bipolar disorder partly due to lacking a widely adopted patient-reported manic symptom measure. OBJECTIVE: To report development and psychometric properties of a brief patient-reported manic symptom measure. DESIGN: Secondary analysis of data collected in a randomized effectiveness trial comparing two treatments for 1004 primary care patients screening positive for bipolar disorder and/or PTSD. PARTICIPANTS: Two analytic samples included 114 participants with varied diagnoses and test-retest data, and 179 participants with psychiatrist-diagnosed bipolar disorder who had two or more assessments with the nine-item Patient Mania Questionnaire-9 [PMQ-9]). MAIN MEASURES: Internal and test-retest reliability, concurrent validity, and sensitivity to change were assessed. Minimally important difference (MID) was estimated by standard error of measurement (SEM) and by standard deviation (SD) effect sizes. KEY RESULTS: The PMQ-9 had high internal reliability (Cronbach's alpha = 0.88) and test-retest reliability (0.85). Concurrent validity correlation with manic symptom measures was high for the Internal State Scale-Activation Subscale (0.70; p<0.0001), and lower for the Altman Mania Rating Scale (0.26; p=0.007). Longitudinally, PMQ-9 was completed at 1511 clinical encounters in 179 patients with bipolar disorder. Mean PMQ-9 score at first and last encounters was 14.5 (SD 6.5) and 10.1 (SD 7.0), a 27% decrease in mean score during treatment, suggesting sensitivity to change. A point estimate of the MID was approximately 3 points (range of 2-4). CONCLUSIONS: The PMQ-9 demonstrated excellent test-retest reliability, concurrent validity, internal consistency, and sensitivity to change and was widely used and acceptable to patients and clinicians in a pragmatic clinical trial. Combined with the Patient Health Questionnaire-9 (PHQ-9) measure of depressive symptoms this brief measure could inform measurement-based care for individuals with bipolar disorder in primary care and mental health care settings given its ease of administration and familiar self-report response format.

Comparison of Teleintegrated Care and Telereferral Care for Treating Complex Psychiatric Disorders in Primary Care: A Pragmatic Randomized Comparative Effectiveness Trial.

Importance: Only one-third of patients with complex psychiatric disorders engage in specialty mental health care, and only one-tenth receive adequate treatment in primary care. Scalable approaches are critically needed to improve access to effective mental health treatments in underserved primary care settings. Objective: To compare 2 clinic-to-clinic interactive video approaches to delivering evidence-based mental health treatments to patients in primary care clinics. Design, Setting, and Participants: This pragmatic comparative effectiveness trial used a sequential, multiple-assignment, randomized trial (SMART) design with patient-level randomization. Adult patients treated at 24 primary care clinics without on-site psychiatrists or psychologists from 12 federally qualified health centers in 3 states who screened positive for posttraumatic stress disorder and/or bipolar disorder and who were not already receiving pharmacotherapy from a mental health specialist were recruited from November 16, 2016, to June 30, 2019, and observed for 12 months. Interventions: Two approaches were compared: (1) telepsychiatry/telepsychology-enhanced referral (TER), where telepsychiatrists and telepsychologists assumed responsibility for treatment, and (2) telepsychiatry collaborative care (TCC), where telepsychiatrists provided consultation to the primary care team. TER included an adaptive intervention (phone-enhanced referral [PER]) for patients not engaging in treatment, which involved telephone outreach and motivational interviewing. Main Outcomes and Measures: Survey questions assessed patient-reported outcomes. The Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score was the primary outcome (range, 0-100). Secondary outcomes included posttraumatic stress disorder symptoms, manic symptoms, depressive symptoms, anxiety symptoms, recovery, and adverse effects. Results: Of 1004 included participants, 701 of 1000 (70.1%) were female, 660 of 994 (66.4%) were White, and the mean (SD) age was 39.4 (12.9) years. Baseline MCS scores were 2 SDs below the US mean; the mean (SD) MCS scores were 39.7 (14.1) and 41.2 (14.2) in the TCC and TER groups, respectively. There was no significant difference in 12-month MCS score between those receiving TCC and TER (ß = 1.0; 95% CI, -0.8 to 2.8; P = .28). Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (TCC: Cohen d = 0.81; 95% CI, 0.67 to 0.95; TER: Cohen d = 0.90; 95% CI, 0.76 to 1.04). For patients not engaging in TER at 6 months, there was no significant difference in 12-month MCS score between those receiving PER and TER (ß = 2.0; 95% CI, -1.7 to 5.7; P = .29). Conclusions and Relevance: In this comparative effectiveness trial of patients with complex psychiatric disorders randomized to receive TCC or TER, significantly and substantially improved outcomes were observed in both groups. From a health care system perspective, clinical leadership should implement whichever approach is most sustainable. Trial Registration: ClinicalTrials.gov Identifier: NCT02738944.

Development of research methods curriculum for an integrated care fellowship.

OBJECTIVE: To describe the design and delivery of a curriculum in research methods for clinical fellows in integrated care. METHOD: To design the curriculum, a standard curriculum development approach was applied through an iterative improvement process with input from researchers, clinical educators, and the first cohort of fellows. The curriculum has three central goals: (1) develop fellows' capacity to interpret the integrated care literature and apply findings in practice; (2) develop fellows' capacity for conducting quality improvement programs informed by knowledge of clinical research methods; and (3) enhance workforce capacity for practice-based research partnerships by increasing research understanding among clinical providers. A variety of educational strategies were employed to introduce each research method and apply these to the integrated care literature. RESULTS: A description, rationale, and resources for each content domain is presented. The curriculum was delivered to two cohorts of fellows. Evaluation data supports the curriculum's relevance and quality. CONCLUSIONS: A rigorous development process yielded a brief research curriculum targeting the needs of clinical fellows in integrated care. The curriculum is well-received by fellows and adaptable for other subspecialties. It may serve as a model for other clinical training programs seeking to enhance their fellows' fluency in research methods.

Psychiatrist and Psychologist Experiences with Telehealth and Remote Collaborative Care in Primary Care: A Qualitative Study.

PURPOSE: Availability of mental health services is limited in the rural United States. Two promising models to reach patients with limited access to care are telehealth referral and collaborative care. The objective of this study was to assess telepsychiatrist- and telepsychologist-level facilitators and barriers to satisfaction with and implementation of these 2 telehealth models in rural settings. METHODS: Focus groups were held in 2019 using a semistructured interview guide. Participants were off-site telepsychiatrists (N = 10) and telepsychologists (N = 4) for primary care clinics across 3 states (Washington, Michigan, and Arkansas) involved in a recent pragmatic comparative effectiveness trial. Qualitative analysis occurred inductively by 2 independent coders. FINDINGS: Participants were satisfied with the models partly owing to good patient rapport and expanding access to care. Teamwork was highlighted as a facilitator in collaborative care and was often related to work with care managers. However, participants described communication with primary care providers as a challenge, especially in the telehealth referral arm. Barriers centered on variability of logistical processes (eg, symptom monitoring, scheduling, electronic medical record processes, and credentialing) among sites. Staff turnover, variable clinic investment, and inadequacy of training were possible explanations for these barriers. CONCLUSIONS: Participants described high motivation to provide team-based, remote care for patients, though they experienced operational challenges. Centralized credentialing, scheduling, and record keeping are possible solutions. These findings are important because consulting psychiatrists and psychologists may play a leadership role in the dissemination of these models.

Indirect psychiatric consultation for perinatal bipolar disorder: A scoping review.

OBJECTIVE: To synthesize the literature and develop guidance on supports needed for primary care and perinatal providers in screening, initial management, triage, and bridging treatment for perinatal bipolar disorder. METHODS: We conducted a scoping review by searching six electronic databases using keywords related to perinatal bipolar disorder. We summarized descriptive statistics on settings and extracted information on care approaches. We synthesized the literature on indirect care models and extracted data on screening, follow-up, referrals, and management. RESULTS: 1169 articles were retrieved. 51 articles were included after review. Most papers were reviews. Fewer addressed care in obstetric (n = 20, 39%), primary care (n = 10, 20%), and pediatric settings (n = 2, 4%). Most papers (n = 30, 59%) discussed using screening instruments for bipolar disorder. Articles were mixed on recommendations for bipolar disorder screening. CONCLUSIONS: Varied strategies for structured assessment exist and are influenced by practice setting. There remains uncertainty about optimal strategies for screening and management of perinatal bipolar disorder. We recommend screening for bipolar disorder in the perinatal period in select circumstances (with depression screening, known bipolar disorder risk factors, and prior to starting antidepressants). If specialty mental health care is unavailable, we recommend enhancing usual care through integrated care strategies such as indirect consultation.