Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial.

BACKGROUND: Minor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mild-major depression. We compared the effectiveness of usual primary care treatment, with or without antidepressants, in minor and mild-major depression. METHODS: A pragmatic patient-randomized equivalence trial with 52 weeks follow-up was conducted in The Netherlands. In total, 59 primary care physicians (PCPs) recruited and treated 181 adult patients with minor or mild-major depression. Patients were randomized to four consultations within 3 months of usual care plus antidepressants (UCandAD) or usual care alone (UCnoAD). The Montgomery Asberg Depression Rating Scale (MADRS) was used to assess changes in severity of depressive symptoms. The predefined equivalence margin was set at five points. Multilevel analysis was used to analyze the data. Secondary outcome measures were the Short-Form 36 (SF-36), and the Client Satisfaction Questionnaire (CSQ-8). RESULTS: Patients received on average 3.0 (SD 1.4) 15-min consultations within 3 months with (n = 85) or without paroxetine (n = 96). Equivalence of UCandAD and UCnoAD was demonstrated in the intention-to-treat analyses as well as the per-protocol analysis after 6 weeks, but not at 13, 26 and 52 weeks follow-up. No statistical differences in effectiveness between treatment groups were found in the intention-to-treat analysis. No differences in the physical and mental functioning (SF-36) were found between the treatment groups. Patients allocated to UCandAD were slightly more satisfied with their treatment at 13 weeks follow-up (but not at 52 weeks follow-up) than patients allocated to UCnoAD. Preliminary analyses suggested that subgroups such as patients with mild-major (instead of a minor) depression might benefit from antidepressant treatment. Patients who were assigned to their preferred treatment (in particular to UCnoAD) were more often compliant and had better clinical outcomes. CONCLUSION: UCandAD was as effective as UCnoAD over the first 6 weeks, but not at 13, 26, and 52 weeks. However, superiority of either treatment could not be demonstrated either. The question whether antidepressants add any clinical effect to usual care remains unresolved. We recommend future studies to look for subgroups of patients who may benefit from antidepressants. TRIAL REGISTRATION: Dutch Trial Registry ISRCN03007807.

Interpersonal psychotherapy (IPT) for late-life depression in general practice: uptake and satisfaction by patients, therapists and physicians.

BACKGROUND: Interpersonal Psychotherapy (IPT) is recommended in most depression treatment guidelines and proved to be a suitable treatment for elderly depressed patients. Despite the favorable results of IPT in research populations, the dissemination to general practice is surprisingly limited. Little is known about uptake and satisfaction when this therapy is introduced into real-life general practice. METHODS: Motivation and evaluation of patients, GPs and therapists were recorded and organizational barriers described alongside a randomized controlled trial. IPT, given by mental health workers, was compared with usual general practitioner (GP) care. Included were patients (> or =55 years) who met the DSM-IV criteria for major depressive disorder. RESULTS: Patients were motivated for the psychotherapy intervention: of the 205 eligible patients, 143 (70%) entered the study, and of the 69 patients who were offered IPT, 77% complied with the treatment. IPT proved to be an attractive therapy for patients as well as for therapists from mental health organizations. General practitioners evaluated the intervention positively afterwards, mainly because of the time-limited and structured approach. Organizational barriers: no IPT therapists were available; an IPT trainer and supervisor had to be trained and training materials had to be developed and translated. Additionally, there was a lack of office space in some general practices; for therapists from private practices it was not feasible to participate because of financial reasons. IPT was superior to usual care in patients with moderate to severe depression. CONCLUSION: As we succeeded in delivering IPT in primary care practice, and as IPT was superior to usual care, there are grounds to support the implementation of IPT for depressed elderly patients within general practice, as long as the practices have room for the therapists and financial barriers can be overcome. Consolidation may be achieved by making this intervention available through practice nurses or community psychiatric nurses who deliver IPT as part of a more comprehensive depression management program.

Administering the MADRS by telephone or face-to-face: a validity study.

BACKGROUND: The Montgomery Asberg Depression Rating Scale (MADRS) is a frequently used observer-rated depression scale. In the present study, a telephonic rating was compared with a face-to-face rating in 66 primary care patients with minor or mild-major depression. The aim of the present study was to assess the validity of the administration by telephone. Additional objective was to study the validity of the first item, 'apparent sadness', the only item purely based on observation. METHODS: The present study was a validity study. During an in-person interview at the patient's home a trained interviewer administered the MADRS. A few days later the MADRS was administered again, but now by telephone and by a : Mean total score on the in-person administration was 24.0 (SD = 11.1), and on the telephone administration 23.5 (SD = 10.4). The ICC for the full scale was 0.65. Homogeneity analysis showed that the observation item 'apparent sadness' fitted well into the scale. CONCLUSION: The full MADRS, including the observation item 'apparent sadness', can be administered reliably by telephone.

A pharmacy-based coaching program to improve adherence to antidepressant treatment among primary care patients.

The effects on adherence and depressive symptoms of a community pharmacy-based coaching program, including a take-home videotape, were evaluated in a randomized controlled trial in the Netherlands. A total of 147 depressed primary care patients who had a new antidepressant prescription were included in the study. Adherence was measured with an electronic pill container and was also derived from pharmacy medication records; the latter method was associated with an overestimation of adherence of only 5 percent. Intention-to-treat analyses showed no intervention effect on adherence (73 percent compared with 76 percent), whereas analyses of patients who received the intervention (per protocol) showed improved adherence (73 percent compared with 90 percent). Neither analysis showed effects on depressive symptoms.

Effects of coaching by community pharmacists on psychological symptoms of antidepressant users; a randomised controlled trial.

BACKGROUND: Community pharmacists strive to deliver pharmaceutical care to patients. At the moment, coaching of depressive primary care patients on taking their antidepressants (ADs) is not yet part of their standard care package. AIMS: To investigate the effects of coaching by community pharmacists on psychological symptoms. METHOD: A randomised controlled trial with a 6-month follow-up. OUTCOMES: psychological symptoms with the Hopkins Symptom Checklist (SCL). Intention-to-treat (ITT) was performed with (1) last observation carried forward and (2) with group mean imputation (GMI). RESULTS: Analyses with LOCF and GMI resulted in different findings. The LOCF method revealed that at the 6-month follow-up, the intervention patients were less depressed and less anxious than the controls. The intervention was particularly effective in patients with lower levels of education who received pharmacist's coaching. However, ITT with the GMI method showed no differences in psychological symptoms. Differences between LOCF and GMI were explained by the selective attrition in the intervention arm (attrition intervention patients had lower initial SCL-item scores on depression and anxiety than the completers) and by the higher attrition rate in controls. CONCLUSIONS: Our study indicates that the interpretation of the effects of an intervention on psychological symptoms can differ substantially by the way missing values are imputed. If both LOCF and GMI produce significant differences, efficacy can be concluded. If not, the effects based on ITT analyses with LOCF are based on artefacts. We recommend that positive intervention effects should only be reported when findings with LOCF and GMI are in accordance.

Depression in older persons with versus without vascular disease in the open population: similar depressive symptom patterns, more disability.

BACKGROUND: Clinical studies suggest that vascular depression presents with typical symptom patterns. The aim of the present study is to examine whether depressed older persons in the open population with and without vascular disease show different symptom patterns. METHODS: In the Longitudinal Aging Study Amsterdam (LASA), a depressed cohort with (n=114) and without (n=292) vascular disease was identified. Depression was measured using self-reports (CES-D). Vascular disease was confirmed or ruled out using a combination of self-reported data, medication use and reports from general practitioners. RESULTS: No significant differences were found in depressive symptom patterns, in symptom clusters nor individual items of the CES-D. Depressed subjects with vascular disease showed much more disability than those without vascular disease. Age of onset of depression did not show statistically significant difference. CONCLUSIONS: From our study in the open population, there is no evidence to support the hypothesis that depressed older persons with vascular disease have a distinct depressive symptom profile, but they do show more disability.

Reliability and validity of the assessment of depression in general practice: the Short Depression Interview (SDI).

General practitioners (GPs) are recommended to use DSM-IV criteria to diagnose major depression in daily clinical practice. This implies the assessment of nine depressive symptoms and four additional criteria. A short structured interview has been developed to assess these symptoms and criteria, and a study was carried out to investigate the reliability and validity with which GPs can assess these symptoms and criteria and the DSM-IV diagnosis of major depression. In 14 general practices, 52 patients with symptoms of distress and depression were interviewed twice by their GP, with an interval of one to four days. Furthermore, the patients filled out three depression questionnaires. The reproducibility of eight symptoms and three additional criteria was moderate to good (kappa >0.40). The reproducibility of the depressive symptom count, that is necessary to arrive at a diagnosis of major depression, was such that in 75 percent of the patients the test-retest difference did not exceed one symptom. The reproducibility of the diagnosis of major depression was good (kappa 0.63). The validity of the diagnosis of major depression assessed by the GPs, as compared to results of the self-report depression questionnaires, was satisfactory (r 0.35-0.61). Diagnosing major depression in patients with depressive symptomatology just above or below the threshold of major depression warrants a certain amount of caution in general practice.

The prognosis of minor depression in the general population: a systematic review.

Minor depression is common in the general population. There is no consensus about prognostic indicators that can identify people at high and low risk of chronicity. We systematically reviewed the available literature on the prognosis of minor depression in the general population and identified five studies. Two of these were considered to be of relatively high methodological quality. There was a wide variety among the studies in the definitions of minor depression, the characteristics of the study population, length of follow-up and type of outcome measure. The results show that the majority of people with minor depression have a favorable prognosis; 46-71.4% achieve remission after a follow-up of 1-6 years. However, 16-62.3% still have a minor depression after 5 months to 1 year of follow-up, suggesting that for many people minor depression is chronic or recurrent; 12.7-27% develop a more severe form of depression; they were diagnosed with dysthymia or major depression after 1-6 years of follow-up. There was inconsistent evidence regarding mortality and functional impairment. No study presented results of prognostic factors, so it remains unclear which people have a more favorable course than others. The results of our review need to be interpreted with caution because of the small number of studies and the large heterogeneity among studies.

Patients' preferences in the treatment of depressive disorder in primary care.

Patients' preferences in the treatment of depression are important in clinical practice and in research. Antidepressant medication is often prescribed, but adherence is low. This may be caused by patients preferring psychotherapy, which is often not available in primary care. In randomized clinical trials, patients' preferences may affect the external validity. The aim of this article is to study patients' preferences regarding psychotherapy and antidepressant medication and the impact of these preferences on treatment outcome. A systematic review of the literature was performed. The majority of patients preferred psychotherapy in all available studies. Antidepressants were often regarded as addictive and psychotherapy was assumed to solve the cause of depression. Discussing and supporting preferences as part of a quality improvement program of depression care, resulted in more patients receiving the treatment that was most suitable to them. In two patient-preference trials, preferences did not influence treatment outcome. It can be concluded that a substantial percentage of well-informed patients prefer psychotherapy. Patients with strong preferences, mostly for psychotherapy, are likely not to enter antidepressant treatment or randomized clinical trials if their preferences are not supported.

Development and feasibility of a modified reattribution model for somatising patients, applied by their own general practitioners.

Reattribution has been developed as a cognitive-behavioural treatment model for somatisation in general practice. Our objective is to make reattribution suitable for application on patients with long-standing somatisation, including hypochondria, and to evaluate feasibility. Three modifications were developed: (1) dealing with persistent illness worry, (2) adjustment of the doctor's speed to that of the patient, and (3) the use of symptom diaries. Performance of ten experienced general practitioners (GPs), after a 20h training programme (six sessions of variable length), was measured by self-registrations and audio-taped consultations. GPs were interviewed on factors interfering with performance. Nine GPs completed the course. Reattribution was applied to 51 out of 75 indicated somatising patients, which required on average three consultations of 10-30min duration. We conclude that the modified reattribution model offers a feasible approach to the broad spectrum of somatisation seen in general practice; only the modification 'dealing with illness worry' showed limited feasibility.

Effectiveness of disease management programmes for recognition, diagnosis and treatment of depression in primary care.

OBJECTIVES: Screening is advocated to improve the recognition of patients with major depression in primary care. Furthermore, disease management programmes are advocated to improve the quality of care and outcome for these patients. But is screening and the subsequent implementation of a disease management programme more effective than usual care? METHODS: Review of the literature on the effects of disease management programmes that include screening for major depression in general practice. RESULTS: Six randomised controlled trials were identified in which the effectiveness of disease management programmes were studied in patients with major depression in primary care and compared with usual care. The majority of these, and especially the largest, showed positive effects on the recognition, diagnosis, treatment and outcome of patients. Populations in the US seem to benefit most. CONCLUSION: The results of disease management programmes for major depression in primary care that include screening are positive and are more effective than usual care. Therefore, if proceeded by screening, attention to the whole process of care for patients with major depression instead of paying attention to isolated elements of the process is justified.

The prognosis of undetected depression in older general practice patients. A one year follow-up study.

BACKGROUND: Late-life depression often remains undetected in primary care. However, as there is evidence that GPs do identify those with the most severe and persistent disorders, it is important to know more about the prognosis of depressive disorders that are not detected by GPs. METHODS: A one-year follow-up study of depressed patients of 55 years and older consulting their GP in The Netherlands. A two-stepped screening procedure was used to diagnose depression using the GDS-15 and PRIME-MD. GPs and patients were not informed about the results. The course of depression was measured with the MADRS and PRIME-MD, at six and twelve months. Remission was defined by no longer fulfilling DSM-criteria for depressive disorder and a MADRS-score below 10. The prognosis of those not detected by GPs was compared to those that were detected. RESULTS: 73 patients were followed for one year. Among the 49 (67%) patients that were not detected by their GP as being depressed, 33% had remitted after one year. Of the 24 (33%) depressed patients that were detected by their GP, 37% had remitted after one year. Detected patients tended to have more serious depression and more comorbid anxiety than undetected patients. CONCLUSIONS: Although GPs identify older depressed patients who are most in need of treatment, the prognosis of patients that go undetected is poor.

Primary care management of major depression in patients aged > or =55 years: outcome of a randomised clinical trial.

BACKGROUND: Late-life depression is associated with chronic illness, disability, and a poor prognosis. Primary care management may be in need of improvement. AIM: To compare the effects of an intervention programme that aims to improve the identification, diagnosis, and treatment of depression in patients aged > or =55 years with the effects of usual care. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: General practices in the Netherlands. METHOD: Trained GPs performed the intervention and their practice assistants conducted the screenings. Patients were screened with the 15-item Geriatric Depression Scale (GDS-15) and given a consultation with the GP who diagnosed depression with the mood module of the Primary Care Evaluation of Mental Disorders (PRIME-MD). Antidepressant treatment was proposed. Primary outcomes were measured with the Montgomery Asberg Depression Rating Scale (MADRS). Trained independent research assistants performed independent evaluations in both arms. RESULTS: Eighteen practices (23 GPs) were allocated to the intervention and 16 practices (20 GPs) to usual care. From June 2000 to September 2002, 3937 patients were screened; 579 patients had a positive score on the GDS-15, 178 had major depression, of whom 145 participated in the trial. MADRS scores for the intervention group dropped from 21.66 at baseline to 9.23 at 6 months, and the usual care group from 20.94 at baseline to 11.45 at 6 months. MADRS scores decreased during the year in both arms. For the intervention group, these scores increased between 6 and 12 months. CONCLUSION: The programme resulted in lower MADRS scores in the intervention group than in the usual care group, but only at the end of the intervention, at 6 months after baseline.

The prognosis of depression in older patients in general practice and the community. A systematic review.

BACKGROUND: Little is known about the prognosis of depression in older patients in general practice or the community. OBJECTIVES: To summarize available evidence on the course and prognostic factors of depression in older persons. METHODS: We conducted a systematic, computerized search of Medline and PsycINFO. Manual search of references of included studies were done. Studies potentially eligible for inclusion were discussed by two reviewers. Methodological quality was independently assessed by two reviewers. Data regarding selection criteria, duration of follow-up, outcome of depression and prognostic factors were extracted. RESULTS: We identified 40 studies reporting on four cohorts in general practice and 17 in the community. Of all, 67% were of high quality. Follow-up was up to 1 year in general practice and up to 10 years in the community. Information on treatment was hardly provided. About one in three patients developed a chronic course. Five cohorts used more than two measurements during follow-up, illustrating a fluctuating course of depression. Using a best evidence synthesis we summarized the value of prognostic indicators. General practice studies did not provide strong evidence for any factor. Community studies provided strong evidence for an association of baseline depression level, older age, external locus of control, somatic co-morbidity and functional limitations with persistent depression. CONCLUSION: Within the older population, age seems to be a negative prognostic factor, while older people are more likely to be exposed to most of the other prognostic factors identified.

Nontricyclic antidepressants: predictors of nonadherence.

According to professionals, medication nonadherence is often attributed to adverse effects or early remission. There is, however, little evidence to support these attributions. Our aim was to study the predictors of nonadherence in primary care patients with a new antidepressant (AD) prescription. We used a prospective cohort study with 6-month follow-up among 147 primary care patients who were newly prescribed with a nontricyclic AD for depression. They were recruited in 19 community pharmacies in the Netherlands that were linked to 85 general practitioners. An electronic pill container (medication event monitoring system; Aardex Ltd, Untermüli, Switzerland) registered the adherence for 6 months. The predictive values of patient, prescriber, pharmacist, and drug-related characteristics were expressed in univariate and multivariate odds ratios with 95% confidence intervals. Outcome measures showed nonadherence, as expressed in these factors (all dichotomous): (1) incorrect intakes (<80% period coverage); (2) extra pill intakes (>1 per day); (3) drug holidays (>or=1). We found that not only a positive drug attitude, the most important predictor, but also adverse effects, early treatment response, longer onset of depression, and a higher educational level predicted the correct intake of ADs. Extra intakes were predicted by ADs with a shorter half-life and by experience of adverse effects. Drug holidays were predicted by patients with less social support and a negative drug attitude. In conclusion, the predictors of adherence were multifactorial and varied across the 3 adherence types. A positive drug attitude emerged as the most important predictor for correct intakes and drug holidays.

Differences in heart rate variability between depressed and non-depressed elderly.

OBJECTIVE: To determine whether older primary care patients with a Major Depressive Disorder (MDD) have lower heart rate variability (HRV) compared to non-depressed patients. HRV is a measure of cardiac autonomic functioning. METHOD: A cross-sectional comparison of 136 elderly persons with MDD and 136 non-depressed controls (matched for age and gender) recruited in family practices in the Netherlands. Depression was determined according to the DSM-IV criteria using the PRIME-MD. HRV was measured with an electrocardiogram (ECG) during a 5-minute supine rest. RESULTS: Multivariate analyses showed statistically significant decrease in HRV in MDD patients compared with controls. CONCLUSION: Older primary care patients with MDD have a reduced HRV. This may explain why depression is a risk factor for cardiovascular disease and mortality.

Interpersonal psychotherapy for elderly patients in primary care.

OBJECTIVE: Interpersonal psychotherapy (IPT) is recommended in most depression treatment guidelines, but little is known about its effectiveness in real-life practice. This study investigates whether IPT, delivered by mental health workers to elderly patients with major depressive disorder, is more effective than usual general practitioners' care (CAU). METHODS: A pragmatic randomized, controlled trial was conducted in which 143 patients were allocated to IPT (10 sessions) or to CAU. PRIMary care Evaluation of Mental Disorders (PRIME-MD) and Montgomery Asberg Depression Rating Scale (MADRS) assessments were used as primary outcomes. RESULTS: IPT was significantly more effective in reducing the percentage of patients with a diagnosis of depression (PRIME-MD), but not in inducing remission (MADRS <10). Among treatment completers, IPT was superior in improving social and overall mental functioning. A post hoc analysis revealed that IPT was superior to CAU in moderately to severely depressed patients, but not significantly so in mildly depressed patients. CONCLUSIONS: IPT was more effective than CAU for elderly patients with moderate to severe major depressive disorder in general practice. Future research should focus on determinants of treatment outcome.

Prevalence of depression in older patients consulting their general practitioner in The Netherlands.

BACKGROUND: Little is known about the prevalence of depression in older patients consulting their general practitioner. AIM: To estimate the prevalence of major and minor depression in older GP attendees. DESIGN: Cross sectional two-stage screening design. SETTING: Seventeen GPs in urban and 41 GPs in rural settings. METHODS: Data of The West Friesland Study were used. Five thousand, six hundred and eight-six GP attendees of 55 years and older filled in the Geriatric Depression Scale-15 items as a screening instrument for depression (response 62%). Of those screened positive on the GDS-15, 846 (77.5%) were interviewed using the Primary Care Evaluation of Mental Disorders (PRIME-MD). A random sample (n = 102) scoring below the threshold of the GDS-15 was interviewed to estimate the proportion of false negatives. RESULTS: Major depression was prevalent in 13.7% and minor depression in 10.2% of the patients. Depressed patients were older (mean difference 0.7 years; p = 0.037), more often female (OR 1.3; p < 0.001) and lived more often in urban districts (OR 1.5; p < 0.001). Patients with major depression were younger (mean difference 1.9 years; p < 0.001) and more often female (OR 1.4; p = 0.026) than those with a minor depression. Only 22.9% of the patients with a major depression were treated with antidepressants. CONCLUSION: Depression in older GP attendees is a very common health problem. Further research should focus on identifying those groups of patients with high risk of persistence of depression. This could help to focus the limited resources available in general practice to those patients in whom treatment is most urgently needed.

Gender differences in health-related quality of life among asthma patients.

OBJECTIVE: To identify and explain differences between men and women with asthma regarding health-related quality of life (HRQoL). METHODS: A cross-sectional study was performed among 967 asthma patients recruited from general practice. Data were collected by means of a pulmonary function assessment, a face-to-face interview, and a written questionnaire. RESULTS: Women with asthma reported lower scores on HRQoL in the age groups 16-34 and 56-75 years but not in the age group 35-55 years. In all age groups, women reported more severe dyspnea but had higher levels of pulmonary function. The poorer HRQoL reported by women could be explained by a more severe dyspnea and a higher level of medication use in women. CONCLUSIONS: The finding that women with asthma aged 16-34 and 56-75 years report poorer HRQoL than men is not due to a more severe disease state in terms of pulmonary obstruction but does seem to be related to a more severe subjective disease state in women than in men.

Disease control in general practice patients with asthma.

OBJECTIVES: To examine asthma control in conjunction with medication use in asthma patients from general practice. To determine features of patients with inadequately controlled asthma. METHODS: A cross-sectional study was performed among 661 adult asthma patients recruited from general practice. Disease control was defined by: (1) respiratory symptoms; (2) forced expiratory volume in 1s (FEV(1))% predicted; (3) PEF variability; and (4) the use of beta2-agonists. Medical treatment was categorised according to the step-care therapy rules following the 1997 guideline of the Dutch College of General Practitioners (DDGP). RESULTS: Of the 661 asthma patients studied, 262 (40%) had a good disease control, 84 (13%) a mildly reduced, 235 (36%) a moderately reduced, and 80 (12%) had a poor disease control. Of the 399 patients (60%) inadequately controlled, in 292 patients (44%) adequate control might be achieved by changing treatment, in 99 patients (15%) adequate control might not completely be achieved by changing treatment, and 8 (1%) were already maximally treated. Compared to patients with a good disease control, patients inadequately controlled were usually older, less educated, younger at onset of pulmonary complaints, and in addition had more severe dyspnea and poorer health-related quality of life (HRQoL). CONCLUSION: Using our criteria, a substantial proportion of asthma patients primarily treated in general practice is not adequately controlled. Assessing patients' disease control together with the level of medical treatment may help to gain insight into the effectiveness of current disease management.