Effectiveness of a blended multidisciplinary intervention for patients with moderate medically unexplained physical symptoms (PARASOL): A cluster randomized clinical trial.

INTRODUCTION: In patients with moderate Medically Unexplained Physical Symptoms (MUPS), interventions focusing on both physical and psychological aspects are recommended. A proactive, blended and integrated physical therapy and mental health nurse intervention (PARASOL) might reduce complaints, stimulate self-management and prevent chronicity. OBJECTIVE: To investigate short- and long-term effectiveness of the PARASOL intervention compared to usual care on subjective symptom impact and quality of life in patients with moderate MUPS. METHODS: We conducted a cluster randomized clinical trial. The 12-week intervention integrated face-to-face sessions with the physical therapist and mental health nurse and access to a web-based program consisting of graded activity, exercises and information modules. Primary outcomes were subjective symptom impact, as registered with the adequate relief question, and quality of life. Secondary outcomes were severity of (psychosocial) symptoms, overall current health, physical behaviour, illness perceptions, and self-management skills. Assessment took place at baseline, after three and twelve months. RESULTS: Compared to usual care (n = 80), the number of patients in the PARASOL intervention (n = 80) that reported adequate short-term relief was higher (31.2% in intervention group vs. 13.7% in control group). On quality of life and secondary outcomes no significant between group differences in short- and long-term were found. CONCLUSIONS: The PARASOL intervention does improve subjective symptom impact of patients with moderate MUPS on short-term. No additional beneficial effects on the other outcomes and the long-term were found.

Identifying Treatment Modalities for a Multidisciplinary and Blended Care Intervention for Patients With Moderate Medically Unexplained Physical Symptoms: Qualitative Study Among Professionals.

BACKGROUND: Medically unexplained physical symptoms (MUPS) are a substantial health problem in primary care with a high burden for patients, general practitioners, and the health care system. Most studies focus on chronic MUPS patients. Little research is conducted in patients with moderate MUPS, and an effective primary care intervention for prevention of chronic MUPS is lacking. OBJECTIVE: The objective of our study was to identify treatment modalities based on expert opinions for the development of a multidisciplinary and blended intervention for patients with moderate MUPS to prevent chronicity. METHODS: Two focus groups with 8 and 6 experts (general practitioners, physical therapists, psychologists, and mental health nurses) were carried out. The focus groups were structured using the nominal group technique. RESULTS: A total of 70 ideas were generated from two nominal group meetings, and 37 of these got votes, were included in the rank order, and were sorted into 8 separate themes. According to the participants, the most important treatment modalities for a multidisciplinary and blended intervention in patients with moderate MUPS were (1) coaching to a healthier lifestyle, (2) education regarding psychosocial factors, (3) therapeutic neuroscience education, (4) multidisciplinary intake, (5) multidisciplinary cooperation and coordination, (6) relaxation or body awareness exercises, (7) clear communication by professionals to the patient, and (8) graded activity. Five independent researchers checked the ideas and linked them to themes to confirm the content analysis and check the validity of the themes. CONCLUSIONS: From professional expert perspectives, 8 themes should be included in a multidisciplinary and blended intervention to prevent chronicity. These themes provide a first step in developing an intervention for patients with moderate MUPS. Future research should focus on further development steps in which patients with moderate MUPS should be involved to determine if the intervention matches their needs.

Effectiveness of a Blended Multidisciplinary Intervention for Patients with Moderate Medically Unexplained Physical Symptoms (PARASOL): Protocol for a Cluster Randomized Clinical Trial.

BACKGROUND: Medically unexplained physical symptoms are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic medically unexplained physical symptoms is substantial for patients, health care professionals, and society. Therefore, early identification of patients with moderate medically unexplained physical symptoms is needed in order to prevent chronicity. The preventive screening of medically unexplained physical symptoms (PRESUME) screening method was developed using data from the electronic medical record of the patients' general practitioner and demonstrated its prognostic accuracy to identify patients with moderate medically unexplained physical symptoms. In the next step, we developed a proactive blended and integrated mental health and physical therapy intervention program (PARASOL) to reduce complaints of moderate medically unexplained physical symptoms, stimulate self-management, and prevent chronicity. OBJECTIVE: The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate medically unexplained physical symptoms compared with usual care. Secondary objectives are to study the effect on severity of physical and psychosocial symptoms, general health, physical behavior, illness perception, and self-efficacy in patients with moderate medically unexplained physical symptoms as well as to determine the cost-effectiveness of the program. METHODS: This paper presents the study protocol of a multicenter cluster randomized clinical trial. Adult patients with moderate medically unexplained physical symptoms will be identified from electronic medical record data using the PRESUME screening method and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate medically unexplained physical symptoms (124 patients per arm) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of 4 face-to-face consultations with the mental health nurse and 5 physical therapy sessions, supplemented with a Web-based program. The Web-based program contains (1) information modules and videos on self-management and educative themes, (2) videos and instructions on prescribed home exercises, and (3) assignments to gradually increase the physical activity. The program is directed at patients' perception of symptoms as well as modifiable prognostic risk factors for chronicity using therapeutic neuroscience education. It encourages self-management, as well as an active lifestyle using a cognitive behavioral approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of physical and psychosocial symptoms, general health, physical behavior, illness perceptions, self-efficacy, and cost-effectiveness. All measurements will be performed at baseline, 3 and 12 months after baseline. Retrospective cost questionnaires will also be sent at 6 and 9 months after baseline and these will be used for the cost-effectiveness analysis. RESULTS: The intervention has been developed, and the physical therapists and mental health nurses in the participating experimental health care centers have received two days of training on the content of the blended PARASOL intervention. The recruitment of health care centers started in June 2016 and inclusion of patients began in March 2017. Follow-up assessments of patients are expected to be completed in March 2019. CONCLUSIONS: This study is the first randomized clinical trial to determine the effectiveness (including cost-effectiveness) of a proactive, blended, and integrated mental health and physical therapy care program for patients with moderate medically unexplained physical symptoms. The findings will help to improve the treatment for patients with moderate medically unexplained physical symptoms and prevent chronicity. TRIAL REGISTRATION: Netherlands Trial Register NTR6755; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755 (Archived by WebCite at http://www.webcitation.org/6ywporY7u).

Somatisation as a risk factor for incident depression and anxiety.

OBJECTIVE: In this study, we aimed to examine somatisation as a risk factor for the onset of depressive and anxiety disorders. METHODS: 4-year follow-up data from the Netherlands Study of Depression and Anxiety (NESDA), a multisite cohort study of the course of depression and anxiety, was analysed. Participants (18-65 years) without a lifetime depressive or anxiety disorder at baseline were included (n=611). Somatisation was measured at baseline with the somatisation subscale of the 4 Dimensional Symptoms Questionnaire. Onset of depression and anxiety was assessed with the CIDI interview at 2-year and 4-year follow-up. RESULTS: Somatisation was a risk factor for the incidence of depression [Hazard Ratio per unit increase (HR); 95% Confidence Interval (CI): 1.13; 1.09-1.17] and anxiety [HR; 95% CI: 1.14; 1.09-1.18]. Associations attenuated but remained statistically significant after adjusting for socio-demographic characteristics, chronic somatic disorders, and baseline levels of (subclinical) depressive or anxiety symptoms [adjusted HR for depression; 95% CI: 1.06; 1.00-1.12, adjusted HR for anxiety; 95% CI: 1.13; 1.07-1.20]. CONCLUSION: Persons who somatise have an increased risk of becoming depressed or anxious in subsequent years, over and above baseline levels of depressive or anxiety symptoms. They may represent a target group for prevention of depressive and anxiety disorders.

Longitudinal association between pain, and depression and anxiety over four years.

OBJECTIVE: Many patients with depression and/or anxiety (D/A) persistently report pain. However, it is not clear how the course of D/A is associated with pain over time. The present study assessed longitudinal associations between D/A and pain, and compared pain over time between D/A and healthy controls. METHODS: 2676 participants of the Netherlands Study of Depression and Anxiety were followed-up for four years. At three waves (baseline, 2, 4years) we assessed depressive and anxiety symptom severity. Using DSM-IV criteria, we also assessed four different D/A disorder courses over time (n=2093): incident, remitted, chronic, and no D/A (reference group). Pain was assessed at the three waves by severity and number of locations. RESULTS: Change in D/A symptoms was positively associated with change in pain symptoms. Compared to healthy controls (n=519), D/A subjects - incident (n=333), remitted (n=548) or chronic (n=693) - reported more severe pain (b=0.4-0.7, p<0.001) and more pain locations (b=0.8-1.4, p<.001) at all waves, with the highest ratings in chronic D/A. Remission of D/A during follow-up was associated with a significant decline in pain (severity; p=0.002, number of locations; p<.001), but pain levels remained significantly higher compared to healthy controls. Findings were similar for separate depression or anxiety course. CONCLUSIONS: This study largely confirms synchrony of change between depression, anxiety and pain. However, even after depression and anxiety remission, subjects report higher pain ratings over time. Individuals with D/A (history) seem to be at increased risk of chronic pain.

The association of depression and anxiety with pain: a study from NESDA.

Chronic pain is commonly co-morbid with a depressive or anxiety disorder. Objective of this study is to examine the influence of depression, along with anxiety, on pain-related disability, pain intensity, and pain location in a large sample of adults with and without a depressive and/or anxiety disorder. The study population consisted of 2981 participants with a depressive, anxiety, co-morbid depressive and anxiety disorder, remitted disorder or no current disorder (controls). Severity of depressive and anxiety symptoms was also assessed. In separate multinomial regression analyses, the association of presence of depressive or anxiety disorders and symptom severity with the Chronic Pain Grade and location of pain was explored. Presence of a depressive (OR = 6.67; P<.001), anxiety (OR = 4.84; P<.001), or co-morbid depressive and anxiety disorder (OR = 30.26; P<.001) was associated with the Chronic Pain Grade. Moreover, symptom severity was associated with more disabling and severely limiting pain. Also, a remitted depressive or anxiety disorder showed more disabling and severely limiting pain (OR = 3.53; P<.001) as compared to controls. A current anxiety disorder (OR = 2.96; p<.001) and a co-morbid depressive and anxiety disorder (OR = 5.15; P<.001) were more strongly associated with cardio-respiratory pain, than gastro-intestinal or musculoskeletal pain. These findings remain after adjustment for chronic cardio respiratory illness. Patients with a current and remitted depressive and/or anxiety disorder and those with more severe symptoms have more disabling pain and pain of cardio-respiratory nature, than persons without a depressive or anxiety disorder. This warrants further research.

Pain, not chronic disease, is associated with the recurrence of depressive and anxiety disorders.

BACKGROUND: Studies suggest that poor physical health might be associated with increased depression and anxiety recurrence. The objectives of this study were to determine whether specific chronic diseases and pain characteristics are associated with depression and anxiety recurrence and to examine whether such associations are mediated by subthreshold depressive or anxiety symptoms. METHODS: 1122 individuals with remitted depressive or anxiety disorder (Netherlands Study of Depression and Anxiety) were followed up for a period of four years. The impact of specific chronic diseases and pain characteristics on recurrence was assessed using Cox regression and mediation analyses. RESULTS: Chronic diseases were not associated with recurrence. Neck (HR 1.45, p < .01), chest (HR 1.65, p < .01), abdominal (HR 1.52, p < .01) pain, an increase in the number of pain locations (HR 1.10, p < .01) and pain severity (HR 1.18, p = .01) were associated with an increased risk of depression recurrence but not anxiety. Subthreshold depressive symptoms mediated the associations between pain and depression recurrence. CONCLUSIONS: Pain, not chronic disease, increases the likelihood of depression recurrence, largely through its association with aggravated subthreshold depressive symptoms. These findings support the idea of the existence of a mutually reinforcing mechanism between pain and depression and are indicative of the importance of shedding light on neurobiological links in order to optimize pain and depression management.

Pain and the onset of depressive and anxiety disorders.

Patients with pain may be at increased risk of developing a first episode of depressive or anxiety disorder. Insight into possible associations between specific pain characteristics and such a development could help clinicians to improve prevention and treatment strategies. The objectives of this study were to examine the impact of pain symptomatology on depression and anxiety onset and to determine whether these associations are independent of subthreshold depressive and anxiety symptoms. Data from the Netherlands Study of Depression and Anxiety, collected between 2004 and 2011, were used. A total of 614 participants with no previous history and no current depression or anxiety at baseline were followed up for 4 years. Onset of depressive or anxiety disorder was assessed at 2- and 4-year follow-up by Composite International Diagnostic Interview. Baseline pain characteristics were location, duration, and severity, as assessed by chronic pain grade. Onset of depressive or anxiety disorder occurred in 15.5% of participants. Using Cox survival analyses, onset of depression and anxiety was associated with 6 pain locations (neck, back, head, orofacial area, abdomen, and joints; hazard ratio [HR]=1.96 to 4.02; P<.05), increasing number of pain locations (HR=1.29; P<.001), and higher severity of pain (HR=1.57; P<.001). By contrast, there was no association with duration of pain symptoms (HR=1.47; P=.12). Independent of subthreshold affective symptoms, only joint pain and increasing number of pain locations were still significantly associated with depression and anxiety onset. Clinicians should be aware that regardless of affective symptoms, pain, particularly at multiple locations, is a risk indicator for developing depressive and anxiety disorders.

The role of somatic health problems in the recognition of depressive and anxiety disorders by general practitioners.

BACKGROUND: Recognition of depression and anxiety by general practitioners (GPs) is suboptimal and there is uncertainty as to whether particular somatic health problems hinder or facilitate GP recognition. The objective of this study was to investigate the associations between somatic health problems and GP recognition of depression and anxiety. METHODS: We studied primary care patients with a DSM-IV based psychiatric diagnosis of depressive or anxiety disorder during a face-to-face interview (n=778). GPs' registrations of depression and anxiety diagnoses, based on medical file extractions, were compared with the DSM-IV based psychiatric diagnoses as reference standard. Somatic health problems were based on self-report of several chronic somatic diseases and pain symptoms, using the Chronic Pain Grade (CPG), during the interview. RESULTS: Depression and anxiety was recognized in sixty percent of the patients. None of the health problems were negatively associated with recognition. Greater severity of pain symptoms (OR=1.18, p=.02), and chest pain (OR=1.56, p=.02), in particular, were associated with more GP recognition of depression and anxiety. Mediation analyses showed that depression and anxiety in these patients were better recognized through the presence of more severe psychiatric symptoms. LIMITATIONS: Some specific chronic diseases had low prevalence. CONCLUSIONS: This study shows that the presence of particular chronic diseases does not influence GP recognition of depression and anxiety. GPs tend to recognize depression and anxiety better in patients with pain symptoms, partly due to more severe psychiatric symptoms among those with pain.

Anxiety and depression are associated with migraine and pain in general: an investigation of the interrelationships.

UNLABELLED: There is a well-established comorbidity between migraine and anxiety and depression (A/D). Here, we investigate whether this relationship is specific for migraine and A/D or whether other types of pain are also consistently associated with A/D. In addition, we test whether there is a consistent association between migraine and other types of pain when comorbidity with A/D is controlled for. Data on A/D, migraine, and 6 nonheadache pain locations (back, neck, orofacial area, abdomen, joints, and chest) were analyzed in 2,981 participants from the Netherlands Study of Depression and Anxiety (NESDA). It was tested whether the prevalence of pain in each individual location, as well as the total number of pain locations, depended on A/D and migraine status. A/D was consistently associated with pain in all measured locations. Migraine was also associated with pain in all anatomical sites, but these associations weakened substantially after correction for A/D severity, suggesting that a considerable part of the comorbidity of migraine and other types of pain may be explained by A/D. These findings emphasize the importance of accounting for A/D in studies of pain comorbidity. This will contribute to a better understanding of the mechanisms underlying A/D and pain. PERSPECTIVE: Anxiety and depression are consistently associated with pain, regardless of anatomical site. These disorders may be important factors in the co-occurrence of different pain disorders. Awareness of this comorbidity and a better understanding of the underlying mechanisms may facilitate adequate treatment of both types of conditions.

Impact of pain on the course of depressive and anxiety disorders.

The combination of pain and depression or anxiety is commonly seen in clinical practice. Little is known about the influence of pain on psychopathology over time, as previous studies have been mainly cross-sectional. The objectives of this study are to determine the impact of pain on the course of depressive and/or anxiety disorders, and investigate to what extent the association between pain and course of these mental disorders is mediated by psychiatric characteristics. Data from the Netherlands Study of Depression and Anxiety (NESDA), collected between 2004 and 2009, were used. A total of 1209 participants with a depressive and/or anxiety disorder at baseline were followed up for 2 years. Baseline pain was assessed by location, duration, use of pain medication, and severity (based on Chronic Pain Grade). Course of depressive and anxiety disorders was assessed by Composite International Diagnostic Interview (CIDI) and Life Chart Interview. A higher number of pain locations (OR=1.10; P=.008), joint pain (OR=1.64; P<.001), ≥ 90 days of pain (OR=1.40; P=.009), daily use of pain medication (OR=1.57; P=.047), and a higher Chronic Pain Grade score (OR=1.27; P<.001) were associated with worse course of depressive and anxiety disorders. These associations were largely mediated by baseline severity of the mental disorder. However, joint pain remained associated with a worse course independent of baseline psychiatric characteristics. This study shows that patients with pain are more prone to a chronic course of depressive and anxiety disorders. More attention to pain seems to be necessary when diagnosing and treating these disorders. Future research should focus on treatment modalities for this co-occurrence, with joint pain in particular.

Urinary incontinence management in women: audit in general practice.

OBJECTIVES: In several Western European countries guidelines regarding urinary incontinence (UI) management in general practice have been drawn up. The aim of this study was to evaluate guideline adherence with feedback in general practice in order to improve UI management. METHODS: First, a retrospective audit of female patient records was performed with Egton Medical Information System compared with the NICE Guideline regarding UI. Between 1 January 2000 and 31 December 2006 patients, 18-65 years of age, with newly diagnosed UI (ICPC U04) were included in two general practices in Nottingham, UK. Second, results were presented to the general practitioners (GPs) in a feedback session. RESULTS: Sixty-five patients were identified to have newly reported UI. Gynaecological examination was performed in 51% of cases. Additionally, in 40% of patients a urine sample was obtained for dipstick. Follow-up was performed in 34% of the 65 cases. During a feedback session GPs became aware they do not adhere to these guideline items consistently. Patients often report UI as final after several other problems during one single consultation. CONCLUSION: Most women with UI were not managed according to the NICE Guideline. Audit feedback created awareness of current UI management in general practice and can therefore be used in improving UI management.

Parental acceptance of Human Papillomavirus vaccines.

OBJECTIVE: To determine whether parents would accept Human Papillomavirus (HPV) vaccination for their children and which variables may influence their decision, including knowledge about cervical cancer and HPV. STUDY DESIGN: Three hundred and fifty-six parents of children aged 10-12 years were interviewed regarding the acceptance of an HPV vaccine for their children and their knowledge of HPV and cervical cancer. All data were recorded anonymously. Results were compared using the chi(2)- and the Mann-Whitney test. RESULTS: HPV vaccination would be accepted by 88% of the parents, preferably when the child is aged 10-12 years. Parents of children who received all the vaccinations of the National Vaccination Programme accepted HPV vaccination significantly more. Less than a third of all parents had heard of HPV, and 14% were aware of the causal relationship of HPV and cervical cancer. Knowledge of HPV and cervical cancer, religion, age, education, and marital status did not show any significant relation with HPV vaccine acceptance. CONCLUSIONS: A majority of the parents would accept HPV vaccination. HPV vaccine acceptance seems to be dependent on vaccine acceptance in general, even more than on knowledge of HPV and its causal relation with cervical cancer. However, parents requested more information about cervical cancer, HPV, and HPV vaccination, before the HPV vaccine is introduced.