Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study).

BACKGROUND: Chronic musculoskeletal pain and depression are very common in primary care patients. Furthermore, they often appear as comorbid conditions, resulting in additive effect on adverse health outcomes. On the basis of previous studies, we hypothesise that depression and chronic musculoskeletal pain may benefit from an integrated management programme at primary care level. We expect positive effects on both physical and psychological distress of patients. OBJECTIVE: To determine whether a new programme for an integrated approach to chronic musculoskeletal pain and depression leads to better outcomes than usual care. DESIGN: Cluster-randomised controlled trial involving two arms: a) control arm (usual care); and b) intervention arm, where patients participate in a programme for an integrated approach to the pain-depression dyad. SETTINGS: Primary care centres in the province of Tarragona, Catalonia, Spain, Participants: We will recruit 330 patients aged 18-80 with moderate or severe musculoskeletal pain (Brief Pain Inventory, average pain subscale ≥5) for at least 3 months, and with criteria for major depression (DSM-IV). INTERVENTION: A multicomponent programme according to the chronic care model. The main components are care management, optimised antidepressant treatment, and a psychoeducational group action. Blind measurements: The patients will be monitored through blind telephone interviews held at 0, 3, 6 and 12 months. OUTCOMES: Severity of pain and depressive symptoms, pain and depression treatment response rates, and depression remission rates. ANALYSIS: The outcomes will be analysed on an intent-to-treat basis and the analysis units will be the individual patients. This analysis will consider the effect of the study design on any potential lack of independence between observations made within the same cluster. ETHICS: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAP), Barcelona, (P14/142). DISCUSSION: This project strengthens and improves treatment approaches for a major comorbidity in primary care. The design of the intervention takes into account its applicability under typical primary care conditions, so that if the programme is found to be effective it will be feasible to apply it in a generalised manner. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02605278 ; Registered 28 September, 2015.

Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement).

BACKGROUND: Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. DESIGN: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. SETTING: 20 primary care centres in the province of Tarragona (Spain) SAMPLE: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV) and who need to initiate antidepressant treatment INTERVENTION: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. MEASUREMENTS: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial). These interviews will be given at 0, 3, 6 and 12 months. MAIN VARIABLES: Severity of the depressive symptoms, response rate and remission rate. ANALYSIS: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. DISCUSSION: The effectiveness of caring for depression in primary care can be improved by various strategies. The most effective models involve organisational changes and a greater role of nurses. However, these models are almost exclusively from the USA, and this randomized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system. TRIAL REGISTRATION: ISRCTN16384353.

Somatized depression in primary care attenders.

OBJECTIVE: The aim of this study is to determine, within the context of primary care, the frequency of the various ways in which depression is presented with respect to somatic symptoms and to compare depressed patients who present their distress somatically with those with psychological complaints. METHOD: In the two-phase cross-sectional study, first, we screened 906 consecutive patients, and second, we interviewed in detail 306 selected patients. RESULTS: The prevalence of depression was 16.8% (CI 95%: 13.4-20.2). There were 59 cases with psychological presentation, 45 somatizers and 16 had organic disorders with depressive comorbidity. Somatizers had lower level of education, and somatized depression was less serious and caused less repercussion. Detection, antidepressive treatment and psychiatric care were lower for somatizers than for psychologizers. CONCLUSIONS: Somatization is a frequent way to present depression in primary care. For somatizers, depression is less severe and is associated with less repercussion. Somatization is associated with the under-detection of the underlying psychiatric process.