DÄ internationalArchive10/2019Panic Disorder in Primary Care: The Effects of a Team-Based Intervention

Original article

Panic Disorder in Primary Care: The Effects of a Team-Based Intervention

A cluster randomized trial

Dtsch Arztebl Int 2019; 116(10): 159-66; DOI: 10.3238/arztebl.2019.0159

Gensichen, J; Hiller, T S; Breitbart, J; Brettschneider, C; Teismann, T; Schumacher, U; Lukaschek, K; Schelle, M; Schneider, N; Sommer, M; Wensing, M; König, H; Margraf, J

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 difference 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.

LNSLNS

Panic disorder with/without agoraphobia (PDA) is associated with decreased quality of life of those affected (1) and increased health care costs (2). In Germany, the prevalence of panic disorder in primary care is approximately 5% (3, 4). Even though it is a comparatively common condition, panic disorder is frequently overlooked and not treated (5). For most patients with panic disorder, the general practitioner is the first, and often the only, contact (6). Cognitive behavioral therapy and antidepressants are effective first-line therapies (7, 8).

Previous studies used collaborative care models (adaptions of Wagner’s chronic care model [9, 10]) to improve treatment in the primary care setting. These models typically comprise systematic monitoring, collaboration between the primary care provider and the specialist/therapist as well as psychiatric counseling (9, 11). A systematic review with meta-analysis on the effect of collaborative care for patients with anxiety disorders in the primary care setting showed that collaborative care was superior to treatment as usual (TAU) (effect size for all anxiety disorders: standardized mean difference [SMD]: 0.35; 95% confidence interval: [0.14; 0.56]; effect size for panic disorder: SMD: 0.59; [0.41; 0.78]) (12). Apparently, anxiety patients prefer psychotherapeutic interventions, such as cognitive-behavioral therapy (CBT), to pharmacotherapy (13). CBT contributes to long-term clinical improvements too (14).

In Germany, waiting times for psychotherapeutic treatment to become available can be up to several months (15). Thus, a low-threshold treatment offering adapted to the general practitioner (GP) practice setting seems to be a suitable option to bridge the waiting time (16). The aim of this study was to evaluate the effects of a team-based intervention with case management in patients with panic disorder in a primary care setting. It was hypothesized that this intervention results in a significantly greater improvement of symptoms of anxiety after six months compared to treatment as usual.

Methods

Study design and subjects

See the eMethods section for a detailed description of the methodology used.

“Jena-PARADIES“ (Patient Activation foR Anxiety DIsordErS) was a cluster-randomized intervention study with a two-arm parallel group design (intervention group versus TAU control group) (17). To prevent contamination of control group patients, GP practices were the randomization units (clusters).

Patients were screened by the teams of the participating GP practices, using the Overall Anxiety Severity and Impairment Scale (OASIS) (18) and the panic modules of the Patient Health Questionnaire (PHQ) (19). The general practitioner invited patients with suspicious scores for a diagnostic interview during which the patient’s eligibility for participating in the study was verified using validated ICD-10 check lists (ICD, International Classification of Diseases) (20).

Only adult patients diagnosed with PDA (ICD-10: F41.0 or F40.01) were included in the study. The exclusion criteria were as follows: suicidality, psychotic or substance-related disorders, severe physical impairments, pregnancy or ongoing anxiety-specific psychotherapy. The general practitioners were responsible for including eligible patients and obtaining their informed consents to study participation.

Randomization

After a three-month recruitment period for each practice, cluster randomization of the GP practices was performed (allocation ratio 1:1).

Interventions

The practice team–supported exposure training comprised evidence-based elements of CBT (psychoeducation, interoceptive and situational anxiety exposure exercises) (21) as well as intervention elements from the chronic care model (22).

Intervention group patients received a therapy companion book, providing information about psychoeducation and how to perform the exercises, as well as exposure log sheets. Four structured GP visits were scheduled in a 23-week period; during the first 3 visits, an introduction into the CBT elements was given. Starting from the second GP visit, patients were encouraged to independently perform anxiety exposure exercises at least twice a week. To ensure current symptoms of anxiety are monitored at regular intervals and to enhance treatment adherence, checklist-based telephone monitoring was carried out by a nurse of the GP practice (23). In case of suboptimal monitoring results, the general practitioners could arrange for additional patient contacts and/or adaptions to be made to the exercise plan. Patients in the control group received standard therapy, i.e. guideline-based psychosocial or psychopharmacological treatment (6, 24).

The general practitioners were free to administer whatever treatment they deemed necessary and make referrals at their own discretion.

Endpoints

The primary endpoint was the clinical severity of the anxiety symptoms measured using the Beck Anxiety Inventory (BAI) (25). The patients used this instrument to rate how severely affected they had been by 21 typical symptoms of anxiety (range 0–63) during the last week.

Secondary endpoints included

  • number and severity of panic attacks, measured using 2 items (A1, A2) of the panic and agoraphobia scale (PAS) (26)
  • agoraphobic avoidance behavior, measured using the mobility inventory (MI), “alone“ subscale (27)
  • depression measured using the Patient Health Questionnaire (PHQ-9) (19)
  • patient evaluation of the medical care received, measured using the Patient Assessment of Chronic Illness Care (PACIC) (28)..

Measurements were performed at baseline (T0), at 6-month follow-up (T1) and at 12-month follow-up (T2). Patient-side baseline variables were reported by the patients or by their general practitioners.

Sample size calculation

With a standard deviation of the BAI of 11 (2), a standardized effect size of 0.35 (i.e. a BAI mean difference of 3.85 points) could be demonstrated with a power of 80% in a patient-randomized study with 130 patients per treatment group, using the t test. Assuming an intracluster correlation of 0.07 (2) and a cluster size of 6, a design effect of 1.35 (correction factor for sample size adaption with cluster randomization) was calculated. When in addition a dropout rate of 20% was assumed, 222 patients from 37 practices per treatment group were required.

Statistical analysis

Intention-to-treat (ITT) analyses were performed using the SAS 9.4 software package. For the analysis of intervention effects, linear mixed models (LMMs) and generalized LMMs, taking the hierarchical data structure into account (maximum likelihood method), were adapted (29). Fixed-effects estimators are reported with 95% confidence intervals. The statistical test for clinical improvements referred to the interaction between the factors treatment group and time (two-sided α = 0.05).

Using the “clinical significance“ approach (30), dichotomous measures for response to treatment and for remission were calculated. “Response“ was defined as a statistically reliable BAI score decrease. “Remission“ was defined as a BAI score decrease below the weighted midpoint between the empirical BAI score distribution in our sample (T0) and a comparable patient sample without anxiety disorders (30, 31).

The data on remission after 12 months were used to calculate the number needed to treat (NNT).

Results

Course of the study

The Figure shows the CONSORT flowchart. The median cluster size was 6 (interquartile range [IQR] 4–7). Altogether, 219 patients (53.2%) were included prior to practice randomization. The 6-month follow-up was responded to by 175/230 (76%) patients of the intervention group and by 163/189 (86%) patients of the control group; the 12-month follow-up by 168/230 (73%) and 150/189 (79%), respectively (dropout analysis in the eTables 1 and 2).

Study participants

The two treatment groups were similar with regard to practice and patient characteristics (Tables 1a and b). Prior to the intervention, 341 patients (82%) experienced up to 3 panic attacks weekly (eTable 3), 73 (18%) experienced 4 or more attacks weekly. The severity of these panic attacks (eTable 4) was rated by 96 patients (24%) as mild or moderate and by 226 (55%) as severe or extremely severe. Comorbid depression was observed in 143 patients (35%).

GP practice sample description
GP practice sample description
Table 1a
GP practice sample description
Sample description of GP patients with panic disorder
Sample description of GP patients with panic disorder
Table 1b
Sample description of GP patients with panic disorder

Conduct of the intervention

Data on the conduct of the scheduled GP visits were obtained from 199/230 patients (87%). These data showed that 129 (65%) patients received all 4 GP visits, 152 (76%) at least the first 3 GP visits (which informed about the CBT elements), 168 (84%) at least the first 2 GP visits, and 17 (9%) no visit at all (information about dropouts provided in eTable 5).

A median of 10 practice nurse monitoring activities (IQR: 6–10) was performed. The mean consultation time was 27.4 minutes (standard deviation [SD]: 5.8; range: 15–45) and practice nurse monitoring time 8.2 minutes (SD: 3.5; range: 2–30). The mean duration of the total intervention (up to GP visit 4) was 157 days (IQR: 140–196).

In the control group, the patients had a median of 4 GP visits during the intervention period (IQR: 3–6). The general practitioners of the control group patients usually provided the following interventions:

  • exploration of psychosocial problems
  • recommendation not to avoid anxiety-triggering stimuli (72%), and
  • prescription of selective serotonin reuptake inhibitors (SSRIs) (62%), benzodiazepines, as required, (40%) and/or tricyclic antidepressants (18%) (24).

Analysis of the primary endpoints

The ITT analysis (Table 2) showed at 6-month follow-up in each of the two groups a significant decline in mean anxiety severity (BAI, range: 0–63) (intervention group: −8.5 [−10.3; −6.6], control group: −5.4 [−7.3; −3.4]; raw data listed in eTable 6). Between the 6-month follow-up and the 12-month follow-up, this trend continued in a weakened form. A significant interaction of the factors group and time (p = 0.008) confirmed that the intervention group had seen stronger improvements compared to the control group. The group differences in mean BAI scores were as follows: after 6 months −3.0 [−5.8; −0.2] and after 12 months −4.0 [−6.9; −1.2]. The location of the GP practice (urban versus rural [stratification variable]) had no significant effect (p = 0.93). A sensitivity analysis based on multiple imputation (see eMethods) confirmed these results.

Intention to treat analysis of the endpoints *1
Intention to treat analysis of the endpoints *1
Table 2
Intention to treat analysis of the endpoints *1

As shown by explorative analyses of individual BAI score changes, patient response to treatment was more frequently observed in the intervention group (i.e. decrease of the BAI score by at least 10.3 points). After 6 months, this occurred in the intervention group in 59 patients (37%) and in the control group in 46 patients (31%); after 12 months in 66 (42%) and 45 (32%) patients, respectively. Likewise, remission of symptoms (i.e. decrease of the BAI score to less than 11.1 points) was significantly more often observed in the intervention group. After 6 months, this was noted in the intervention group in 44 patients (27%) and in the control group in 19 patients (13%); after 12 months in 54 patients (34%) and 23 patients (16%), respectively. The NNT was 6.

Analysis of secondary endpoints

In both groups, the number of panic attacks was found reduced (eTable 7); the decrease was significantly greater in the intervention group compared to the control group (p = 0.019). Likewise, the intervention group showed greater improvements with regards to agoraphobic avoidance behavior (MI), depression (PHQ-9) and perceived quality of care (PACIC) compared to the control group (Table 2). The severity of panic attacks was reduced in both groups (eTable 8, p = 0.13). Intake of psychotropic medications was reported by 55% of patients (eTable 9); there was no difference in this respect at the 12-month follow-up between the two groups.

Discussion

In patients with panic disorder with/without agoraphobia, practice team–supported exposure training led to a more pronounced reduction in anxiety symptoms compared to treatment as usual. The mean anxiety levels improved in both groups during the intervention period from severe to moderate. Differences in anxiety reduction between the groups were minor to moderate, largely comparable with effect sizes of measures of anxiety observed in collaborative care studies with specialist involvement (12, 32, 33). The effects remained stable over a period of 12 months. This could indicate that patients in the intervention group learnt health-related behavior and self-management strategies which stabilized the progress made (34).

Based on the 12-month remission data, an NNT of 6 was calculated. This indicates a rather good effect of the intervention (35) and is comparable to results of similar studies (13). The improvements with regard to avoidance behavior and depression achieved in the intervention group were statistically significant. This may have facilitated the interaction between general practitioner and patient and improved treatment adherence by the patient (36).

In an earlier study where general practitioners had been trained in anxiety treatment, no effects on the clinical endpoints was noted (2). The treatment effects observed in our study are comparable with those in studies on stepped care or collaborative care models for anxiety disorders in a primary care setting, all of which involved a psychologist/psychotherapist and/or other healthcare professionals to perform or monitor the intervention (13, 32, 33, 37). Our study shows the practice team–supported interventions are feasible. Offering low-threshold interventions in primary care may help to optimize patient safety, quality of care and access to evidence-based treatments. Future studies should investigate whether GP practice-based interventions are associated with changes in acceptance of primary medicine or psychotherapeutic services offered.

Compared to other studies, patients here showed good treatment compliance (37, 38). Additional analyses of individual BAI score changes demonstrated that in the intervention group remission of symptoms of anxiety was achieved in approximately one third of the patients. Since this is twice as high compared to the control group, it is reasonable to assume that the intervention was effective. Future studies should evaluate patient characteristics associated with the acceptance and benefit of the intervention to facilitate decision-making for individual treatments. Based on the reduced amount of follow-up data on pharmacotherapy and on the limited quality of patient self-reporting, we do not believe that the intervention had an effect on the treatment with psychotropic medications.

Strengths of the study

In a large sample of patients receiving primary care, an intervention was evaluated which empowers and encourages patients to independently perform exposure exercises (21). To ensure transferability of its results, the study was conducted in single-GP practices or small group practices which are typical for the German primary care setting, accounting for the largest portion of healthcare services provided (39).

Disadvantages of the study

The open recruitment of about half of the patients could have introduced selection bias. However, this appears unlikely because no significant differences with regard to socioeconomic and clinical baseline data were found between patients who were included before and after practice randomization. In the intervention group, the proportion of missing follow-up data was higher compared to the control group, but altogether still similar to that in other studies on CBT-based interventions in primary care (13). The LMM analyses help to avoid an overestimation of the effects. In addition, we performed a sensitivity analysis based on multiple imputation of missing data points which confirmed the results of the primary analysis. Even though the BAI is a generic measure of anxiety, it can be used to assess symptoms typically associated with panic disorder; its validity and sensitivity to change have been proven in the primary care setting (31, 37). The reliability of the BAI was excellent in our sample. Waiting times for the intervention should not have affected symptom severity: On the one hand, the general practitioners in both groups were familiarized with the clinical care guidelines; on the other, patients of the control group benefited from participating in the study because they received well organized GP care and increased clinical attention (40).

Conclusion

GP practice teams (GP and practice nurse) can successfully treat patients with PDA using elements of CBT and continuous case management. The intervention was carried out in small GP practices which are the mainstay of primary care delivery in Germany. In this setting, resources are often limited and the implementation of complex collaborative care models is challenging.

Acknowledgement
The authors would like to thank the participating general practitioners, members of the non-medical practice staff and patients, as well as the members of the scientific staff of the Institute of General Practice and Family Medicine at the Jena University Hospital and of the Jena-PARADIES study group.

A special acknowledgment to Michael von Korff, Seattle, USA

Collaborators

Dr. Wolfgang Blank, Kirchberg im Wald; Dr. Florian Bleibler, Hamburg-Eppendorf; Jörg Breitbart, Jena; Dr. Christian Brettschneider, Hamburg-Eppendorf; Anne Brokop, Jena; Prof. Dr. Jochen Gensichen, München; Thomas Hiller, Jena; Dr. Heike Hoyer, Jena; Dr. Bert Huenges, Bochum; Michelle Kaufmann, Jena; Prof. Dr. Hans-Helmut König, Hamburg-Eppendorf); Dr. Armin Mainz, Korbach; Prof. Dr. Jürgen Margraf, Bochum; Pauline Masopust, Jena; Alexander Piwtorak, Jena; Rebekka Salzmann, Jena; Prof. Dr. Sylvia Sänger, Jena; Mercedes Schelle, Jena; Prof. Dr. Peter Schlattmann, Jena; Dr. Konrad Schmidt, Jena; Nico Schneider, Jena; Elisabeth Schöne, Jena; Dr. Sven Schulz, Jena; Dr. Ulrike Schumacher, Jena; Michael Sommer, Jena; Monika Storch, Jena; Dr. Tobias Teismann, Bochum; Franziska Theune-Hobbs, Jena; Dr. Paul Thiel, Jena; Prof. Dr. Michel Wensing, Heidelberg, Germany

Availability of the data and the material
The data on which the results published in this study are based are subject to access restrictions and cannot be made publicly available. However, the data can be requested from the Principal Investigator (PI) of the study, Prof. Gensichen (Jochen.Gensichen@med.uni-muenchen.de) within the framework of an individual project agreement.

Study registration
Current Controlled Trials (www.isrctn.com/ISRCTN64669297)

German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) (www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004386)

Funding
The study was funded by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) (Funding no.: 01GY1146).

Ethics Committee and informed consent
The Ethics Committee of the Friedrich-Schiller University Jena granted approval of the study protocol on 17 August 2012 (no. 3484–06/12). All participating physicians and patients gave their written informed consent to participating in the study.

Conflict of interest
The authors declare no conflict of interest

Manuscript received on 4 July 2018; revised version accepted on 25 January 2019

Translated from the original German by Ralf Thoene, MD.

Corresponding author
Prof. Dr. med. Jochen Gensichen
Institut für Allgemeinmedizin
Klinikum der Ludwig-Maximilians-Universität München
Pettenkoferstr. 10
80336 München, Germany
jochen.gensichen@med.uni-muenchen.de

Supplementary material

eMethods, eTables:
www.aerzteblatt-international.de/19m0159

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Institute of General Practice and Family Medicine, University Hospital of the Ludwig-Maximilians University of Munich, Munich, Germany :Prof. Dr. med. Jochen Gensichen, PD Dr. phil. Karoline Lukaschek
Institute of General Practice and Family Medicine, Jena University Hospital, Jena, Germany: Prof. Dr. med. Jochen Gensichen, Dipl.-Psych. Thomas S. Hiller, Jörg Breitbart, Mercedes Schelle, Dipl.-Biol. Nico Schneider, Dr. med. Michael Sommer, Prof. Dr. Michel Wensing
Institute of Psychosocial Medicine and Psychotherapy, Jena University Hospital, Friedrich-Schiller University Jena, Jena, Germany: Dipl.-Biol. Nico Schneider
Institute of Health Economics and Health Care Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany: Dr. rer. biol. hum. Christian Brettschneider, Prof. Dr. med. Hans-Helmut König
Mental Health Research and Treatment Center, Ruhr-University Bochum, Bochum, Germany: PD Dr. phil. Tobias Teismann, Prof. Dr. rer. soc. Jürgen Margraf
Center for Clinical Studies, Jena University Hospital, Jena, Germany:
Dr. rer. medic. Ulrike Schumacher
Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany: Prof. Dr. Michel Wensing
*1 The two authors are co-first authors.
*2 The two authors are co-last authors.
*3 A list with the names of all collaborators can be found at the end of the article.
Key messages
GP practice sample description
GP practice sample description
Table 1a
GP practice sample description
Sample description of GP patients with panic disorder
Sample description of GP patients with panic disorder
Table 1b
Sample description of GP patients with panic disorder
Intention to treat analysis of the endpoints *1
Intention to treat analysis of the endpoints *1
Table 2
Intention to treat analysis of the endpoints *1
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