BackgroundDepression in later life is a common mental disorder with a prevalence rate of between 3% and 35% for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation (BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy accessible intervention for both patients and health care workers (such as nurses), there is no research on the effectiveness of the intervention in inpatient depressed elderly.The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD.Methods/designThe study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60 years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d = 0.7, we intend to include 51 participants per condition (n = 102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life.DiscussionTo our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly population. This research has been approved by the medical research ethics committee for health-care settings in the Netherlands (No. NL26878.029.09) and is listed in the Dutch Trial Register (NTR No.1809).

BackgroundTreatment guidelines for major depressive disorder (MDD) are based on results from randomized clinical trials, among others in psychotherapy efficacy trials. However, patients in these trials differ from routine practice patients since trials use stringent criteria for patient selection. It is unknown whether the exclusion criteria used in psychotherapy efficacy trials (PETs) influence symptom outcome in clinical practice. We first explored which exclusion criteria are used in PETs. Second, we investigated the influence of commonly used exclusion criteria on symptom outcome in routine clinical practice.MethodsWe performed an extensive literature search in PubMed, PsycInfo and additional databases for PETs for MDD. From these, we identified commonly used exclusion criteria. We investigated the influence of exclusion criteria on symptom outcome by multivariate regression models in a sample of patients suffering from MDD according to the MINIplus from a routine clinical practice setting (n=598). Data on routine clinical practice patients were gathered through Routine Outcome Monitoring.ResultsWe selected 20 PETs and identified the following commonly used exclusion criteria: ‘a baseline severity threshold of HAM-D≤14’, ‘current or past abuse or dependence of alcohol and/or drugs’ and ‘previous use of medication or ECT’. In our routine clinical practice sample of patients suffering from MDD (n=598), presence of ‘current or past abuse of or dependence on alcohol and/or drugs’ had no significant influence on outcome.‘Meeting a baseline severity threshold of HAM-D≤14’ and ‘previous use of medication or ECT’ were associated with better outcome, but the explained variance of the models was very small (R2=2-11%).ConclusionsThe most consistently used exclusion criteria are not a major threat to the generalizability of results found in PETs. However, PETs do somewhat improve their results by exclusion of patients with minor depression and patients who used antidepressants prior to psychotherapy.

BackgroundAnxiety disorders are highly prevalent in primary care and cause a substantial burden of disease. Screening on risk status, followed by preventive interventions in those at risk may prevent the onset of anxiety disorders, and thereby reduce the disease burden. The willingness to participate in screening and interventions is crucial for the scope of preventive strategies, but unknown. This feasibility study, therefore, investigated participation rates of screening and preventive services for anxiety disorders in primary care, and explored reasons to refrain from screening.MethodsIn three general practices, screening was offered to individuals visiting their general practitioner (total n = 2454). To assess risk status, a 10-item questionnaire was followed by a telephone interview (including the CIDI) when scoring above a predefined threshold. Preventive services were offered to those at risk. Participation rates for screening and preventive services for anxiety disorders were assessed. Those not willing to be screened were asked for their main reason to refrain from screening.ResultsOf all individuals, 17.3% participated in initial screening, and of those with a possible risk status, 56.0% continued screening. In 30.1% of those assessed, a risk status to develop an anxiety disorder was verified. Of these, 22.6% already received some form of mental health treatment and 38.7% of them agreed to participate in a preventive intervention and were referred. The most frequently mentioned reasons to refrain from screening were the emotional burden associated with elevated risk status, the assumption not to be at risk, and a lack of motivation to act upon an elevated risk status by using preventive services.ConclusionsScreening in general practice, followed by offering services to prevent anxiety disorders in those at risk did not appear to be a feasible strategy due to low participation rates. To enable the development of feasible and cost-effective preventive strategies, exploring the reasons of low participation rates, considering involving general practitioners in preventive strategies, and looking at preventive strategies in somatic health care with proven feasibility may be helpful.

BackgroundDepression in MS patients is frequent but often not treated adequately. An important underlying factor may be physical limitations that preclude face-to-face contact. Internet-based treatment showed to be effective for depressive symptoms in general and could thus be a promising tool for treatment in MS.Methods/designHere, we present a study protocol to investigate the effectiveness of a 5 week Internet-based self-help problem solving treatment (PST) for depressive symptoms in MS patients in a randomized controlled trial. We aim to include 166 MS patients with moderate to severe depressive symptoms who will be randomly assigned to an Internet-based intervention (with or without supportive text-messages) or waiting list control group. The primary outcome is the change in depressive symptoms defined by a change in the sum score on the Beck Depression Inventory (BDI-II). Secondary outcomes will include measures of anxiety, fatigue, cognitive functioning, physical and psychological impact of MS, quality of life, problem solving skills, social support, mastery, satisfaction and compliance rate. Assessments will take place at baseline (T0), within a week after the intervention (T1), at four months (T2) and at ten months follow-up (T3: only the intervention group). The control group will be measured at the same moments in time. Analysis will be based on the intention-to-treat principle.DiscussionIf shown to be effective, Internet-based PST will offer new possibilities to reach and treat MS patients with depressive symptoms and to improve the quality of care.Trial RegistrationThe Dutch Cochrane Center, NTR2772

BackgroundPhobic disorders are highly prevalent and constitute a considerable burden for patients and society. As patients wait for face-to-face psychotherapy for phobic disorders in outpatient clinics, this time can be used for guided self-help interventions. The aim of this study is to investigate a five week internet-based guided self-help programme of exposure therapy in terms of clinical effectiveness and impact on speed of recovery in psychiatric outpatients, as well as the cost-effectiveness of this pre-treatment waiting list intervention.Methods/designA randomised controlled trial will be conducted among 244 Dutch adult patients recruited from waiting lists of outpatient clinics for face-to-face psychotherapy for phobic disorders. Patients suffering from at least one DSM-IV classified phobic disorder (social phobia, agoraphobia or specific phobia) are randomly allocated (at a 1:1 ratio) to either a five-week internet-based guided self-help program followed by face-to-face psychotherapy, or a control group followed by face-to-face psychotherapy. Waiting list status and duration are unchanged and actual need for further treatment is evaluated prior to face-to-face psychotherapy. Clinical and economic self-assessment measurements take place at baseline, post-test (five weeks after baseline) and at 3, 6, 9 and 12 months after baseline.DiscussionOffering pre-treatment internet-based guided self-help efficiently uses time otherwise lost on a waiting list and may increase patient satisfaction. Patients are expected to need fewer face-to-face sessions, reducing total treatment cost and increasing speed of recovery. Internet-delivered treatment for phobias may be a valuable addition to psychotherapy as demand for outpatient treatment increases while budgets decrease.Trial registrationNetherlands Trial Register NTR2233