Implementing brief cognitive behavioral therapy in primary care: A pilot study.
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ABSTRACT:
SUBMITTER: Mignogna J
PROVIDER: S-EPMC4041920 | biostudies-literature | 2014 Jun
REPOSITORIES: biostudies-literature
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Implementing brief cognitive behavioral therapy in primary care: A pilot study.
Mignogna Joseph J Hundt Natalie E NE Kauth Michael R MR Kunik Mark E ME Sorocco Kristen H KH Naik Aanand D AD Stanley Melinda A MA York Kaki M KM Cully Jeffrey A JA
Translational behavioral medicine 20140601 2
Effective implementation strategies are needed to improve the adoption of evidence-based psychotherapy in primary care settings. This study provides pilot data on the test of an implementation strategy conducted as part of a multisite randomized controlled trial examining a brief cognitive-behavioral therapy versus usual care for medically ill patients in primary care, using a hybrid (type II) effectiveness/implementation design. The implementation strategy was multifaceted and included (1) modu ...[more]
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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.
| S-EPMC3503767 | biostudies-literature
Project description:Aim:The aim of the study is to investigate if cognitive behavioral therapy given in a group setting affects anxiety and depression, stress, pain, coping strategies during daily life, and health-related quality of life (HRQoL), among frequent attenders (FAs) in primary care. Methods:Cognitive behavioral therapy was offered to 331 FAs between 18 and 65 years of age, of whom 89 accepted and 54 completed all steps in the protocol; patients were assigned to 1 of 3 groups: 0, 6, and 12-month waiting time. The therapy consisted of 12 sessions administered in group format. Outcome measures were Beck's Anxiety Inventory (BAI), Beck's Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS), Everyday Life Stress (ELS), Coping Strategy Questionnaire, Multidimensional Pain Inventory-Swedish version, and Short Form-36. Results:Mean age among patients who completed cognitive behavioral therapy was 49.9 years, with a female majority (79.6%). Anxiety and depression scores were reduced after treatment (BAI 16.7 vs 13.6; BDI 16.3 vs 15.7; HADS-Anxiety 8.41 vs 6.05; HADS-Depression 7.09 vs 5.69). Because waiting time itself did not affect symptoms, differences reflect treatment effects. Stress ratings were not affected by treatment. Use of nonadaptive coping strategies like praying and hoping and catastrophizing decreased. Frequent attenders experienced a higher sense of life control. Frequent attenders reported significantly lower HRQoL than general Swedish population norms in all 8 Short Form-36 domains including mental and physical component summary scores (MCS and PCS), and all domains were unaffected by treatment. Conclusion:Cognitive behavioral therapy exerts some beneficial effects in FAs. Content of treatment addressed musculoskeletal pain, stress, anxiety, and depression. This broad approach resulted in reduced anxiety, depression, and impact of pain because of enhanced life control.
| S-EPMC6266570 | biostudies-other
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.
| S-EPMC5987469 | biostudies-other
Project description:BackgroundFew studies have examined the practical effectiveness and implementation potential of brief psychotherapies that integrate mental and physical health.ObjectiveTo 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.DesignPragmatic patient-randomized trial comparing bCBT to enhanced usual care (EUC).ParticipantsA 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.InterventionbCBT 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 measuresPrimary 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 resultsParticipants 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.ConclusionsIntegrated 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.
| S-EPMC5570751 | biostudies-literature
Project description:ObjectiveTo report on the 32-week outcome of the Brief Behavioral Therapy (BBT) for Pediatric Anxiety and Depression in Primary Care clinical trial.MethodA total of 185 youths aged 8 to 17 years with anxiety and/or depression identified through 9 pediatric primary care (PPC) settings in San Diego and Pittsburgh were randomized to receive Assisted Referral to Care (ARC) or up to 12 sessions of BBT over 16 weeks. The primary outcome was clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score of ≤2. Secondary outcomes included interview-rated functioning, depression, and anxiety. Here, we report on outcomes at 32 weeks after randomization. All analyses with primary outcomes are corrected for multiple comparisons using the false discovery rate procedure.ResultsAt 32 weeks, BBT was superior to ARC with respect to response (67.5% versus 43.1%, q = 0.03, number needed to treat [NNT] = 5) and functioning (d = 0.49, q = 0.04). BBT was superior to ARC with respect to its impact on anxiety (f = 0.21) but not depressive symptoms (f = 0.05). These findings persisted after controlling for the number of sessions received. Ethnicity moderated the impact of BBT on outcome (NNT for Hispanic youths = 2), because of a much lower response rate to ARC in Hispanic than in non-Hispanic youths (16.7% versus 49.2%, p = 0.04).ConclusionBBT is a promising intervention that can be effectively delivered in PPC and may be particularly effective for Hispanic patients. Further work is indicated to improve its impact on depressive symptoms and to test BBT against other treatments delivered in pediatric primary care.Clinical trial registration informationBrief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care; http://clinicaltrials.gov; NCT01147614.
| S-EPMC6940557 | biostudies-literature
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.
| S-EPMC7961309 | biostudies-literature
Project description:BackgroundFamily members of critically ill patients experience symptoms of postintensive care syndrome-family (PICS-F), including anxiety, depression, and posttraumatic stress disorder. Postintensive care syndrome-family reduces the quality of life of the families of critically ill patients and may impede the recovery of such patients. Cognitive behavioral therapy has become a first-line nonpharmacological treatment of many psychological symptoms and disorders, including anxiety, depression, and posttraumatic stress. With regard to managing mild-to-moderate symptoms, the delivery of cognitive behavioral therapy via mobile technology without input from a clinician has been found to be feasible and well accepted, and its efficacy rivals that of face-to-face therapy.ObjectiveThe purpose of our pilot study is to examine the efficacy of using a smartphone mobile health (mHealth) app to deliver cognitive behavioral therapy and diminish the severity and prevalence of PICS-F symptoms in family members of critically ill patients.MethodsFor our pilot study, 60 family members of critically ill patients will be recruited. A repeated-measures longitudinal study design that involves the randomization of participants to 2 groups (the control and intervention groups) will be used. The intervention group will receive cognitive behavioral therapy, which will be delivered via a smartphone mHealth app. Bandura's social cognitive theory and an emphasis on mental health self-efficacy form the theoretical framework of the study.ResultsRecruitment for the study began in August 2020. Data collection and analysis are expected to be completed by March 2022.ConclusionsThe proposed study represents a novel approach to the treatment of PICS-F symptoms and is an extension of previous work conducted by the research team. The study will be used to plan a fully powered randomized controlled trial.Trial registrationClinicalTrials.gov NCT04316767; https://clinicaltrials.gov/ct2/show/NCT04316767.International registered report identifier (irrid)DERR1-10.2196/30813.
| S-EPMC8374657 | biostudies-literature
Project description:Patients with terminal cancer often experience marked anxiety that is associated with poor quality of life. Although cognitive-behavioral therapy (CBT) is an evidence-based treatment for anxiety disorders, the approach needs to be adapted to address realistic concerns related to having cancer, such as worries about disease progression, disability, and death. In this pilot randomized controlled trial (clinicaltrials.gov identifier NCT00706290), we examined the feasibility and potential efficacy of brief CBT to reduce anxiety in patients with terminal cancer.We adapted CBT by developing treatment modules targeting skills for relaxation, coping with cancer worries, and activity pacing. Adults with incurable malignancies and elevated anxiety based on the Hamilton Anxiety Rating Scale (HAM-A) were randomly assigned to individual CBT or a waitlist control group. Primary outcomes included the number of completed CBT visits and the change in HAM-A scores from baseline to 8-week follow-up per a treatment-blind evaluator. The feasibility criterion was 75% adherence to the intervention.We randomized 40 patients with terminal cancers to CBT (n = 20) or waitlist control (n = 20) groups; 70% completed posttreatment assessments. Most patients who received CBT (80%) participated in at least five of the required six therapy sessions. Analysis of covariance models, adjusted for baseline scores, showed that those assigned to CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for the intervention (Cohen's d = 0.80).Providing brief CBT tailored to the concerns of patients with terminal cancer was not only feasible but also led to significant improvements in anxiety.
| S-EPMC3481900 | biostudies-literature
Project description:To determine the impact of cognitive behavioral therapy on outcomes in primary care, office-based buprenorphine/naloxone treatment of opioid dependence.We conducted a 24-week randomized clinical trial in 141 opioid-dependent patients in a primary care clinic. Patients were randomized to physician management or physician management plus cognitive behavioral therapy. Physician management was brief, manual guided, and medically focused; cognitive behavioral therapy was manual guided and provided for the first 12 weeks of treatment. The primary outcome measures were self-reported frequency of illicit opioid use and the maximum number of consecutive weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report.The 2 treatments had similar effectiveness with respect to reduction in the mean self-reported frequency of opioid use, from 5.3 days per week (95% confidence interval, 5.1-5.5) at baseline to 0.4 (95% confidence interval, 0.1-0.6) for the second half of maintenance (P<.001 for the comparisons of induction and maintenance with baseline), with no differences between the 2 groups (P=.96) or between the treatments over time (P=.44). For the maximum consecutive weeks of opioid abstinence there was a significant main effect of time (P<.001), but the interaction (P=.11) and main effect of group (P=.84) were not significant. No differences were observed on the basis of treatment assignment with respect to cocaine use or study completion.Among patients receiving buprenorphine/naloxone in primary care for opioid dependence, the effectiveness of physician management did not differ significantly from that of physician management plus cognitive behavioral therapy.
| S-EPMC3621718 | biostudies-literature
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.
| S-EPMC5539834 | biostudies-literature