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Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial.

ABSTRACT: BACKGROUND:Few studies have examined the practical effectiveness and implementation potential of brief psychotherapies that integrate mental and physical health. OBJECTIVE:To determine whether an integrated brief cognitive behavioral therapy (bCBT), delivered by mental health providers in primary care, would improve depression, anxiety and quality of life for medically ill veterans. DESIGN:Pragmatic patient-randomized trial comparing bCBT to enhanced usual care (EUC). PARTICIPANTS:A total of 302 participants with heart failure and/or chronic obstructive pulmonary disease (COPD) with elevated symptoms of depression and/or anxiety were enrolled from two Veterans Health Administration primary care clinics. INTERVENTION:bCBT was delivered to 180 participants by staff mental health providers (n = 19). bCBT addressed physical and emotional health using a modular, skill-based approach. bCBT was delivered in person or by telephone over 4 months. Participants randomized to EUC (n = 122) received a mental health assessment documented in their medical record. MAIN MEASURES:Primary outcomes included depression (Patient Health Questionnaire) and anxiety (Beck Anxiety Inventory). Secondary outcomes included health-related quality of life. Assessments occurred at baseline, posttreatment (4 months), and 8- and 12-month follow-up. KEY RESULTS:Participants received, on average, 3.9 bCBT sessions with 63.3% completing treatment (4+ sessions). bCBT improved symptoms of depression (p = 0.004; effect size, d = 0.33) and anxiety (p < 0.001; d = 0.37) relative to EUC at posttreatment, with effects maintained at 8 and 12 months. Health-related quality of life improved posttreatment for bCBT participants with COPD but not for heart failure. Health-related quality of life outcomes were not maintained at 12 months. CONCLUSIONS:Integrated bCBT is acceptable to participants and providers, appears feasible for delivery in primary care settings and is effective for medically ill veterans with depression and anxiety. Improvements for both depression and anxiety were modest but persistent, and the impact on physical health outcomes was limited to shorter-term effects and COPD participants. Clinical trials.Gov identifier: NCT01149772.

SUBMITTER: Cully JA

PROVIDER: S-EPMC5570751 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial.

Cully Jeffrey A JA Stanley Melinda A MA Petersen Nancy J NJ Hundt Natalie E NE Kauth Michael R MR Naik Aanand D AD Sorocco Kristen K Sansgiry Shubhada S Zeno Darrell D Kunik Mark E ME

Journal of general internal medicine 20170620 9

<h4>Background</h4>Few studies have examined the practical effectiveness and implementation potential of brief psychotherapies that integrate mental and physical health.<h4>Objective</h4>To determine whether an integrated brief cognitive behavioral therapy (bCBT), delivered by mental health providers in primary care, would improve depression, anxiety and quality of life for medically ill veterans.<h4>Design</h4>Pragmatic patient-randomized trial comparing bCBT to enhanced usual care (EUC).<h4>Pa ...[more]

PMID: 28634906

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Project description: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.

Project description:BACKGROUND:Primary care clinics present challenges to implementing evidence-based psychotherapies (EBPs) for depression and anxiety, and frontline providers infrequently adopt these treatments. The current study explored providers' perspectives on fidelity to a manualized brief cognitive behavioral therapy (CBT) as delivered in primary care clinics as part of a pragmatic randomized trial. Data from the primary study demonstrated the clinical effectiveness of the treatment and indicated that providers delivered brief CBT with high fidelity, as evaluated by experts using a standardized rating form. Data presented here explore challenges providers faced during implementation and how they adapted nonessential intervention components to make the protocol "fit" into their clinical practice. METHODS:A multiprofessional group of providers (n = 18) completed a one-time semi-structured interview documenting their experiences using brief CBT in the primary care setting. Data were analyzed via directed content analysis, followed by inductive sorting of interview excerpts to identify key themes agreed upon by consensus. The Dynamic Adaptation Process model provided an overarching framework to allow better understanding and contextualization of emergent themes. RESULTS:Providers described a variety of adaptations to the brief CBT to better enable its implementation. Adaptations were driven by provider skills and abilities (i.e., using flexible content and delivery options to promote treatment engagement), patient-emergent issues (i.e., addressing patients' broader life and clinical concerns), and system-level resources (i.e., maximizing the time available to provide treatment). CONCLUSIONS:The therapeutic relationship, individual patient factors, and system-level factors were critical drivers guiding how providers adapted EBP delivery to improve the "fit" into their clinical practice. Adaptations were generally informed by tensions between the EBP protocol and patient and system needs and were largely not addressed in the EBP protocol itself. Adaptations were generally viewed as acceptable by study fidelity experts and helped to more clearly define delivery procedures to improve future implementation efforts. It is recommended that future EBP implementation efforts examine the concept of fidelity on a continuum rather than dichotomized as adherent/not adherent with focused efforts to understand the context of EBP delivery. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01149772.

Project description:ImportanceYouth anxiety and depression are common and undertreated. Pediatric transdiagnostic interventions for anxiety and/or depression may be associated with improved access to treatment among youths.ObjectiveTo evaluate the cost-effectiveness of a pediatric transdiagnostic brief behavioral therapy (BBT) program for anxiety and/or depression compared with assisted referral to community outpatient mental health care (ARC).Design, setting, and participantsIn this economic evaluation, an incremental cost-effectiveness analysis was performed from the societal perspective using data from a randomized clinical trial of youths with full or probable diagnoses of anxiety or depression who were recruited from pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania. The trial was conducted from October 6, 2010, through December 5, 2014, and this analysis was performed from January 1, 2019, through October 20, 2020.InterventionsIn the randomized clinical trial, youths were randomized to BBT (n = 95) or ARC (n = 90). The BBT program consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level therapists. Families randomized to ARC received personalized referrals to mental health care and telephone calls to support access to care.Main outcomes and measuresAnxiety-free days, depression-free days, quality-adjusted life-years (QALYs), and costs based on incremental cost-effectiveness ratios from intake through 32-week follow-up. A cost-effectiveness acceptability curve for QALYs was used to assess the probability that BBT was cost-effective compared with ARC over a range of amounts that a decision-maker might be willing to pay for an additional outcome.ResultsEnrolled patients included 185 youths (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] White; and 38 [20.7%] Hispanic). Youths who received BBT experienced significantly more anxiety-free days (difference, 28.63 days; 95% CI, 5.86-50.71 days; P = .01) and QALYs (difference, 0.026; 95% CI, 0.009-0.046; P = .007) compared with youths who received ARC. Youths who received BBT experienced more depression-free days than did youths who received ARC (difference, 10.52 days; 95% CI, -4.50 to 25.76 days; P = .18), but the difference was not statistically significant. The mean incremental cost-effectiveness ratio was -$41 414 per QALY (95% CI, -$220 601 to $11 468). The cost-effectiveness acceptability curve analysis indicated that, at a recommended willingness-to-pay threshold of $50 000 per QALY, the probability that BBT would be cost-effective compared with ARC at 32 weeks was 95.6%.Conclusions and relevanceIn this economic evaluation, BBT in primary care was significantly associated with better outcomes and a greater probability of cost-effectiveness at 32 weeks compared with ARC. The findings suggest that transdiagnostic BBT may be associated with improved youth anxiety and functioning at a reasonable cost.

Project description:ImportanceAnxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations.ObjectiveTo examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care.Design, setting, and participantsThis 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness.InterventionsThe BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators.Main outcomes and measuresThe primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning.ResultsA total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in the ARC group (n = 90), had significantly higher rates of clinical improvement (56.8% vs 28.2%; χ21 = 13.09, P < .001; number needed to treat, 4), greater reductions in symptoms (F2,146 = 5.72; P = .004; Cohen f = 0.28), and better functioning (mean [SD], 68.5 [10.7] vs 61.9 [11.9]; t156 = 3.64; P < .001; Cohen d = 0.58). Ethnicity moderated outcomes, with Hispanic youth having substantially stronger response to BBT (76.5%) than ARC (7.1%) (χ21 = 14.90; P < .001; number needed to treat, 2). Effects were robust across sites.Conclusions and relevanceA pediatric-based brief behavioral intervention for anxiety and depression is associated with benefits superior to those of assisted referral to outpatient mental health care. Effects were especially strong for Hispanic participants, suggesting that the protocol may be a useful tool in addressing ethnic disparities in care.Trial registrationclinicaltrials.gov Identifier: NCT01147614.

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Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial.

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Delivery of Brief Cognitive Behavioral Therapy for Medically Ill Patients in Primary Care: A Pragmatic Randomized Clinical Trial.

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