Patient characteristics and changes in anxiety symptoms in patients with panic disorder: Post-hoc analysis of the PARADIES cluster randomised trial.

Anxiety disorders are among the most common mental health problems in primary care. The PARADIES (Patient Activation foR Anxiety DIsordErS) intervention combined elements of cognitive behavioural therapy with case management and has demonstrated efficacy. Our aim was to explore patient characteristics, which may influence the course of anxiety symptoms over a 12 months period. Multiple linear regression was used to quantify associations of baseline characteristics (demographics, clinical parameters, medication use) with changes in anxiety symptoms as measured by the Beck anxiety inventory. Treatment modalities (e.g. adherence to appointment schedules) were considered as confounders. We examined univariate associations between dependent and independent variables before considering all independent variables in a multivariate final model. To find the best model to explain BAI score changes, we performed step-wise selection of independent variables based on Akaike information criteria. We tested for interaction terms between treatment allocation (intervention vs control) and independent variables using the multivariate model. We repeated these analyses in control vs intervention groups separately. From the original trial (N = 419), 236 patients (56.3%) were included. In the multivariate model, receiving the intervention (p<0.001), higher anxiety symptom severity (p<0.001) and longer illness duration at baseline (p = 0.033) were significantly associated with changes in anxiety symptom severity to the better while depression severity at baseline (p<0.001) was significantly associated with changes in anxiety symptoms to the worse. In stratified analyses, the control group showed significant associations between depression symptom severity and illness duration with anxiety symptom changes while baseline severity of anxiety symptoms remained significantly associated with anxiety symptom changes in both groups. A brief primary-care-based exposure training combined with case management is effective in a broad range of patients with panic disorder with/without agoraphobia, including those with longer illness duration and co-existing symptoms of depression at baseline.

[Health Assistants Perspectives on Team-Led Program for Patients with Panic Disorder in General Practice - A Qualitative Study]. / Perspektiven von Medizinischen Fachangestellten zu teambasierter Behandlung von Patienten mit Panikstörung in der Hausarztpraxis ­ Eine qualitative Studie.

AIM OF THE STUDY: Investigation of the perspective of medical assistants (MA) regarding their participation in behaviour-therapy oriented interventions in family practice. METHOD: 15 MA (w, 39.5 years old), case managers in a general practitioner supported exercise programme for patients with panic disorder (ICD-10: F41.0), were interviewed using semi-structured interview guidelines on the recruitment and interaction of/with patients, communication of the exercises and implementation in everyday practice. The interviews (n = 14) were documented, transcribed and qualitatively analysed according to Mayring. RESULTS: MA perceived their contribution to the intervention regarding recruitment and monitoring of patients through telephone contacts as positive. CONCLUSION: Strengthening the role of MAs' can help to provide targeted support for patients with mental health problems in GP care as part of a low-threshold intervention and relieve the workload on the GP.

Cost-effectiveness of Practice Team-Supported Exposure Training for Panic Disorder and Agoraphobia in Primary Care: a Cluster-Randomized Trial.

BACKGROUND: Primary care is the main treatment setting for panic disorder and should be supplemented by collaborative care programs. However, shortage of mental health professionals prevents collaborative care programs from being effectively implemented. The PARADISE study showed the efficacy of a self-managed, cognitive-behavioural therapy (CBT)-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the family practice team. OBJECTIVE: To assess the cost-effectiveness of the PARADISE intervention. DESIGN: Cost-effectiveness analysis from the societal perspective based on data from a cluster-randomized controlled trial over a time horizon of 12 months. PARTICIPANTS: Four hundred nineteen adult panic disorder patients with or without agoraphobia. INTERVENTIONS: A self-managed, CBT-oriented exposure training for patients with panic disorder with or without agoraphobia in primary care delivered by the primary care practice team in comparison to routine care. MAIN MEASURES: Total costs from the societal perspective. Direct costs and disease-specific costs. Quality-adjusted life years based on the EQ-5D-3L. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. KEY RESULTS: Patients in the intervention group caused lower costs (mean, €1017; 95% confidence interval [-€3306; €1272]; p = 0.38) and gained on average more QALY (mean, 0.034 QALY (95% confidence interval [0.005; 0.062]; p = 0.02). Therefore, the intervention dominated the control treatment. The probability of cost-effectiveness of the intervention at a willingness-to-pay margin of €50,000 per QALY was 96%. Results from supplementary analyses considering direct or disease-specific costs instead of total costs showed comparable results. CONCLUSION: The PARADISE intervention is cost effective. This conclusion is valid for total costs, generic health care (direct) costs, disease-specific health care costs. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00004386 Current Controlled Trials: ISRCTN64669297.

[Panic disorder and agoraphobia in general practice: Advantages and pitfalls of a practice team-supported exposure training from the general practitioner's perspective - a qualitative study]. / Panikstörung und Agoraphobie hausärztlich behandelt: Vorzüge und Fallstricke eines Praxisteam-unterstützten Expositionstrainings aus Sicht von Hausärztinnen und Hausärzten ­ eine qualitative Studie.

INTRODUCTION: For the treatment of anxiety disorders behavior therapy-oriented methods are recommended for primary care as well. Within the trial "Jena-PARADISE" a primary care practice team-supported exposure training for patients with panic disorder with or without agoraphobia was developed and evaluated. The present paper gives an overview of general practitioners' subjective views on the practicability, feasibility and effectiveness of this new intervention for both patients and GP teams. METHODS: Questions were operationalized based on Bellg's intervention fidelity framework. Fourteen GPs of the intervention group were sampled purposefully and interviewed in a semi-structured way. Generated data were analyzed following Mayring's content analysis approach. RESULTS: The treatment program was positively assessed among the GPs and seen as a useful therapeutic option for inadequately treated patients. The therapy elements 'psycho-education' and 'interoceptive exposure exercises' were described as feasible, while situational exercises and relapse prevention got a less positive rating. The active participation of the nurse in the treatment program was seen as supportive. CONCLUSION: From the GP perspective, the treatment program for patients with panic disorder and/or agoraphobia seems to be a viable therapeutic option in primary care.

The allocation of resources in the care for patients with panic disorder in Germany: an excess cost analysis informing policy and science.

BACKGROUND: Panic disorder is a mental disorder of high prevalence, which frequently co-occurs with agoraphobia. There is a lack of studies measuring excess costs of panic disorder patients with and without agoraphobia. We compared costs of panic disorder patients with or without agoraphobia with costs of the anxiety-free population in Germany. METHODS: Primary data from a cluster-randomized trial of adults suffering from panic disorder (n = 419) and from a representative survey of the German general population (N = 5005) were collected between 2012 and 2014. Missing data from the cluster-randomized trial were first imputed by multiple imputation using chained equations and subsequently balanced with the data from the survey by Entropy Balancing. The societal perspective was chosen. Excess costs were calculated by generalized linear models and two-part-models. RESULTS: Entropy Balancing led to an exact match between the groups. We found 6-month total excess costs of 3220€ (95% CI 1917€-4522€) for panic disorder patients without agoraphobia and of 3943€ (95% CI 2950€-4936€) for patient with agoraphobia. Panic disorder patients with or without agoraphobia had significantly higher costs for psychotherapy, general practitioners, general hospital stays and informal care Indirect costs accounted for approximately 60% of the total excess costs. CONCLUSIONS: Panic disorder with or without agoraphobia is associated with significant excess costs. Agoraphobia changes the pattern of resource utilization. Especially indirect costs are relevant. Agoraphobia influences resource utilization in the inpatient sector.Trial registration ISRCTN64669297.

Symptom trajectories in patients with panic disorder in a primary care intervention: Results from a randomized controlled trial (PARADISE).

This analysis aims to identify and characterize symptom trajectories in primary care patients with panic disorder with/without agoraphobia (PD/AG) who participated in a primary care team based training involving elements of cognitive behavioural therapy (CBT). Growth Mixture Modeling was used to identify different latent classes of change in patients with PD/AG (N = 176) who underwent treatment including CBT elements. We identified three patient classes with distinct similar trajectories. Class 1 (n = 58, mean age: 46.2 years ± 13.4 years, 81% women) consisted of patients with an initially high symptom burden, but symptoms declined constantly over the intervention period. Symptoms of patients in class 2 (n = 89, mean age: 44.2 years ± 14.5 years, 67.4% women) declined rapidly at the beginning, then patients went into a plateau-phase. The third class (n = 29, mean age: 47.0 years ± 12.4 years, 65.5% women) was characterized by an unstable course and had the worse outcome. Our findings show that only a minority did not respond to the treatment. To identify this minority and refer to a specialist would help patients to get intensive care in time.

Panic Disorder in Primary Care.

BACKGROUND: We evaluated a team-based program of exercises for patients with panic disorder with or without agoraphobia (PDA) in primary care. METHODS: 419 patients with PDA (mean age 46.2 years, standard deviation 14.4 years; 74% female) were included in this cluster-randomized, controlled intervention trial. The patients were blinded with respect to their group assignment at baseline. Patients in the intervention group (36 primary-care practices, 230 patients) underwent a 23-week exercise program combined with case management, while patients in the control group (37 practices, 189 patients) received standard care. Symptoms of anxiety (according to the Beck Anxiety Inventory, BAI) at six months were the primary endpoint. Patients were followed up at six months (n = 338, 81%) and at twelve months (n = 318, 76%). The analysis was by intention to treat. RESULTS: Symptoms of anxiety improved to a significantly greater extent in the intervention group (p = 0.008). The intergroup dif- ference in the reduction of the BAI score (range: 0-63) was 3.0 points (95% confidence interval [-5.8; -0.2]) at six months and 4.0 points [-6.9; -1.2] at twelve months. In the intervention group, there was a significantly greater reduction in the frequency of panic attacks (p = 0.019), in avoidant behavior (p = 0.016), and in depressiveness (p<0.001), as well as a greater improvement of the quality of treatment (p<0.001). CONCLUSION: In primary-care patients who have panic disorder with or without agoraphobia, a team-based exercise program combined with case management can improve symptoms to a greater extent than standard primary-care treatment.

Suicidal ideation in primary care patients suffering from panic disorder with or without agoraphobia.

BACKGROUND: Suicidal ideation is common in patients suffering from panic disorder. The present study investigated rates of suicidal ideation and risk factors for suicidal ideation in a sample of primary care patients suffering from panic disorder with or without agoraphobia. METHODS: A total of N = 296 patients [n = 215 (72.6%) women; age: M = 43.99, SD = 13.44] were investigated. Anxiety severity, anxiety symptoms, avoidance behavior, comorbid depression diagnosis, severity of depression, age, sex, employment status, living situation and frequency of visits at the general practitioner were considered as risk factors of suicidal ideation. RESULTS: Suicidal ideation was experienced by 25% of the respondents. In a logistic regression analysis, depression diagnosis and depression severity emerged as significant risk factors for suicidal ideation. Anxiety measures were not associated with suicidal ideation. CONCLUSION: Suicidal ideation is common in primary care patients suffering from panic disorder with or without agoraphobia. Individuals with greater burden of mental illness in terms of mood disorder comorbidity and depressive symptomatology are especially likely to suffer from suicidal ideation.

[The Jena Anxiety Monitoring List (JAMoL) - a tool for the evidence-based treatment of panic disorder with or without agoraphobia in primary care]. / Die Jena Angst-Monitoring-Liste (JAMoL) - ein Instrument zur evidenzbasierten Behandlung von Panikstörung mit oder ohne Agoraphobie in der Hausarztpraxis.

BACKGROUND: Behavior therapy-oriented methods are recommended for treating anxiety disorders in primary care. The treatment of patients with long-term conditions can be improved by case management and structured clinical monitoring. The present paper describes the rationale, design and application of the 'Jena Anxiety Monitoring List' (JAMoL), a monitoring tool for the treatment of patients with panic disorder, with or without agoraphobia, in primary care. METHODS: JAMoL's design was based on established clinical measures, the rationale of exposure-based anxiety treatment, and research on family practice-based case management. After piloting, the JAMoL was used in the clinical study 'Jena-PARADISE' (ISRCTN64669297), where non-physician practice staff monitored patients with panic disorder by telephone. Using semi-structured interviews in concomitant studies, study participants were asked about the instrument's functionality. RESULTS: The JAMoL assesses the severity of anxiety symptoms (6 items) as well as the patient's adherence to therapy (4 items) and fosters the case management-related information exchange (3 items). An integrated traffic light scheme facilitates the evaluation of monitoring results. Within the clinical study, non-physician practice staff carried out a total of 1,525 JAMoL-supported monitoring calls on 177 patients from 30 primary care practices (median calls per patient: 10 [interquartile range, 9-10]). Qualitative analyses revealed that most practice teams and patients rated the JAMoL as a practicable and treatment-relevant tool. CONCLUSIONS: The JAMoL enables primary care practice teams to continuously monitor anxiety symptoms and treatment adherence in patients with panic disorder with or without agoraphobia. Within the behavior therapy-oriented treatment program 'Jena-PARADISE', the JAMoL constitutes an important case management tool.

[Usual Care for Panic Disorder with/without Agoraphobia in Primary Care]. / Standardtherapie für Panikstörung mit/ohne Agoraphobie in der Hausarztpraxis.

OBJECTIVE: To describe therapy as usual (TAU) for panic disorder with/without agoraphobia (PDA) in primary care. METHOD: Written survey of 38 general practitioners (GPs) who provided TAU to 189 patients with PDA as part of an interventional study. Data were analyzed descriptively. RESULTS: The most common TAU-interventions were: exploration of psychosocial problems (83 %), recommendation not to avoid anxiety-provoking stimuli (72 %), prescription of SSRIs (62 %). Common reasons for referrals were various psychiatric comorbidities and treatment-refractory anxiety (77 %). GPs rarely used validated diagnostic tools such as structured interviews (18 %) or questionnaires (14 %). CONCLUSIONS: TAU mostly involved guideline-recommended psychosocial and pharmacological interventions. Study-related procedures may limit the generalizability of findings.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial.

BACKGROUND: Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. METHODS/DESIGN: This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. TRIAL REGISTRATION: Current Controlled Trials [http://ISCRTN64669297].