Anne Daubmann

Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial

BackgroundAnxiety, Depression and Somatoform (ADSom) disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners (GPs). Furthermore, the management of these patients is restricted by the high patient turnover rates in primary care practices, especially in the German health care system.In order to address this problem, we implement a complex, low-threshold intervention by an Advanced Practice Nurse (APN) using a mixture of case management and counseling techniques to promote self-management in these patients. Here we present the protocol of the “Self-Management Support for Anxiety, Depression and Somatoform Disorders in Primary Care” (SMADS)-Study.Methods/DesignThe study is designed as a cluster-randomized controlled trial, comparing an intervention and a control group of 10 primary care practices in each case. We will compare the effectiveness of the intervention applied by an APN with usual GP-care. A total of 340 participants will be enrolled in the study, 170 in either arm. We use the Patient Health Questionnaire-German version (PHQ-D) as a screening tool for psychiatric symptoms, including patients with a score above 5 on any of the three symptom scales. The primary outcome is self-efficacy, measured by the General Self-Efficacy Scale (GSE), here used as a proxy for self-management. As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life. Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment.DiscussionThe SMADS-study evaluates a complex, low threshold intervention for ambulatory patients presenting ADSom-symptoms, empowering them to better manage their condition, as well as improving their motivation to engage in self-help and health-seeking behaviour. The benefit of the intervention will be substantiated, when patients can enhance their expected self-efficacy, reduce their symptom load and engage in more self-help activities to deal with their everyday lives. After successfully evaluating this psychosocial intervention, a new health care model for the management of symptoms of anxiety, depression and somatoform disorders for ambulatory patients could emerge, supplementing the work of the GP.Trial registrationClinicaltrials.gov Identifier: NCT01726387

Effectiveness of Integrated Care Including Therapeutic Assertive Community Treatment in Severe Schizophrenia Spectrum and Bipolar I Disorders: The 24-Month Follow-Up ACCESS II Study

OBJECTIVE The ACCESS treatment model offers assertive community treatment embedded in an integrated care program to patients with psychoses. Compared to standard care and within a controlled study, it proved to be more effective in terms of service disengagement and illness outcomes in patients with schizophrenia spectrum disorders over 12 months. ACCESS was implemented into clinical routine and its effectiveness assessed over 24 months in severe schizophrenia spectrum disorders and bipolar I disorder with psychotic features (DSM-IV) in a cohort study. METHOD All 115 patients treated in ACCESS (from May 2007 to October 2009) were included in the ACCESS II study. The primary outcome was rate of service disengagement. Secondary outcomes were change of psychopathology, severity of illness, psychosocial functioning, quality of life, satisfaction with care, medication nonadherence, length of hospital stay, and rates of involuntary hospitalization. RESULTS Only 4 patients (3.4%) disengaged with the service. Another 11 (9.6%) left because they moved outside the catchment area. Patients received a mean of 1.6 outpatient contacts per week. Involuntary admissions decreased from 34.8% in the 2 previous years to 7.8% during ACCESS (P < .001). Mixed models repeated-measures analyses revealed significant improvements among all patients in psychopathology (effect size d = 0.64, P < .001), illness severity (d = 0.84, P = .03), functioning level (d = 0.65, P < .001), quality of life (d = 0.50, P < .001), and client satisfaction (d = 0.11, P < .001). At 24 months, 78.3% were fully adherent to medication, compared to 25.2% at baseline (P = .002). CONCLUSIONS ACCESS was successfully implemented in clinical routine and maintained excellent rates of service engagement and other outcomes in patients with schizophrenia spectrum disorders or bipolar I disorder with psychotic features over 24 months. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01888627.

Paths to first treatment and duration of untreated illness in anorexia nervosa: are there differences according to age of onset?

This study examined paths to first treatment and the duration of untreated illness in 140 anorexia nervosa patients using validated questionnaires and a clinical interview. The differences between individuals with an early (≤14 years, n = 40), intermediate (15-18 years, n = 53) and late onset (≥19 years, n = 47) were investigated. Participants were most commonly informed about their diagnosis and first treatment facility through general practitioners and paediatricians. The duration of untreated illness exceeded 2 years in the complete sample (25.14 months) and was longest for individuals with an early onset. The early onset group was more often externally vs. internally motivated and more frequently informed about treatment options by their social network, e.g. parents, than patients with a late onset. The results emphasize the relevance of training general practitioners and paediatricians about anorexia, the need to include parents and teachers in eating disorder prevention and to improve targeting young individuals in early interventions.

The relationship between biogenetic attributions and desire for social distance from persons with schizophrenia and major depression revisited

AIMS Previous population-based studies did not support the view that biological and genetic causal models help increase social acceptance of people with mental illness. However, practically all these studies used un-labelled vignettes depicting symptoms of the disorders of interest. Thus, in these studies the publics reactions to pathological behaviour had been assessed rather than reactions to psychiatric disorders that had explicitly been labelled as such. The question arises as to whether results would have been similar if respondents had been confronted with vignettes with explicit mention of the respective diagnosis. METHODS Analyses are based on data of a telephone survey in two German metropolises conducted in 2011. Case-vignettes with typical symptoms suggestive of depression or schizophrenia were presented to the respondents. After presentation of the vignette respondents were informed about the diagnosis. RESULTS We found a statistically significant association of the endorsement of brain disease as a cause with greater desire for social distance from persons with schizophrenia. In major depression, this relation was absent. With both disorders, there was no statistically significant association between the endorsement of hereditary factors as a cause and social distance. CONCLUSIONS Irrespective of whether unlabelled or labelled vignettes are employed, the ascription to biological or genetic causes seems not to be associated with a reduction of the publics desire for social distance from people with schizophrenia or depression. Our results corroborate the notion that promulgating biological and genetic causal models may not help decrease the stigma surrounding these illnesses.

Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial

BackgroundStroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified ‘constraint-induced movement therapy (CIMT) at home’) with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. ‘CIMT at home’ will be compared with conventional physical and occupational therapy (‘therapy as usual’).Methods/designThe study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order.DiscussionA modification of the CIMT, feasible in the patients’ homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.Trial registrationClinicalTrials.gov NCT01343602

Changes in beliefs and attitudes toward people with depression and schizophrenia – results of a public campaign in Germany

We examined the impact of a mental health awareness campaign on public attitudes. The campaign was embedded in the project psychenet - Hamburg Network for Mental Health. Beliefs and attitudes were examined before and after specific awareness measures in Hamburg (intervention region) and Munich (control region). Analyses were based on representative surveys (2011: N=2014; 2014: N=2006). Vignettes with symptoms suggestive of depression respectively schizophrenia were presented, followed by questions on social distance, beliefs and emotional reactions. Analyses of variance tested variations between regions over time and differences between those aware of the campaign and those not aware. In 2014, 7.3% (n=74) of the Hamburg respondents were aware of the psychenet campaign. Regarding the total sample, there were minor changes in attitudes. Differentiated according to campaign awareness among Hamburg respondents, those who were aware showed less desire for social distance toward a person with depression. Moreover, respondents aware of the campaign stated less often that a person with schizophrenia is in need of help. The campaign had small impact on attitudes. A substantial change in ingrained attitudes toward persons with mental health problems is difficult to achieve with interventions targeting the general public.

Brief motivational intervention for adolescents treated in emergency departments for acute alcohol intoxication – a randomized-controlled trial

BackgroundAlcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in Germany are recently growing. The emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential “teachable moment”. However, studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication. In this protocol we present the HaLT-Hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication.MethodsThe trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after 3 and 6 months. N = 312 participants aged 17 years and younger will be recruited Fridays to Sundays in 6 pediatric clinics over a period of 30 months. Intervention condition is a manual-based brief motivational intervention with a telephone booster after 6 weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual. Primary outcomes are reduction in binge drinking episodes, quantity of alcohol use on a typical drinking day and alcohol-related problems. Secondary outcome is further treatment seeking. Linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat (ITT) and completers (per-protocol) principles to examine intervention effects. We also examine quantitative and qualitative process data on feasibility, intervention delivery, implementation and receipt from intervention providers, receivers and regular emergency department staff.DiscussionThe study has a number of strengths. First, a rigorous evaluation of HaLT-Hamburg is timely because variations of the HaLT project are widely used in Germany. Second, prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication. Third, we included a comprehensive process evaluation to raise external validity. Fourth, the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact.Trial registrationCurrent Controlled Trials ISRCTN31234060 (April 30th 2012).

Understanding the impact of statural height on health-related quality of life in German adolescents: a population-based analysis

AbstractImproving health-related quality of life (HrQoL) is one aim of growth hormone treatment for short-statured patients. Yet, evidence of the relationship between height and HrQoL is inconclusive, especially for young people. This study investigates the association of height and HrQoL in the general German adolescent population. A total of 6646 adolescents and 6388 parents from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS) were included in the analysis. An analysis of covariance was used to evaluate the effect of height deviation on HrQoL as assessed with the KINDL-R in adolescent self-report and parent-report, taking into account sociodemographic and health-related variables. Height was found to be a weak predictor of HrQoL in both adolescent-report and parent-report. Short and tall adolescents did not substantially differ from the normal statured. Sociodemographic and health-related variables failed to significantly interact with height. In contrast, psychosocial variables contributed to the explained HrQoL variance. Conclusion: Height does not appear to be a strong determinant of HrQoL on the population level. These results suggest that the height gain in short stature treatment may not be the most important objective. Contrary to prevalent stereotypes, short adolescents can experience a high HrQoL.

Evaluation of a German version of the Strengthening Families Programme 10-14: a randomised controlled trial.

BACKGROUND The purpose of this study is to evaluate the effects of a German adaptation of the Strengthening Families Programme 10-14 (SFP 10-14; Familien Stärken). METHODS A multi-centre randomised controlled trial comparing the German SFP version consisting of seven sessions and four booster-sessions with a minimal intervention on parenting as control condition. Outcomes comprise measures of adolescent substance use (initiation) and behaviour problems and are assessed at baseline, after programme delivery and at 6- and 18-month follow-ups. Primary outcomes were lifetime tobacco, alcohol and cannabis use at 18 months. Data of n = 292 families were analysed using baseline adjusted logistic regressions and mixed models. RESULTS We observed reduced rates of lifetime tobacco use in analyses with follow-up respondents, but not in data using the complete intention to treat sample with multiple imputation estimates for missing data. Parents reported fewer adolescent behaviour problems in analyses with the total sample and multiple imputed data, but not in data with follow-up respondents only. There were no other significant effects of SFP 10-14. CONCLUSION Overall the medium size effects found in previous US trials could not be replicated in a German context.

Short- to Midterm Effectiveness of a Brief Motivational Intervention to Reduce Alcohol Use and Related Problems for Alcohol Intoxicated Children and Adolescents in Pediatric Emergency Departments: A Randomized Controlled Trial.

OBJECTIVES The proportion of children and adolescents receiving emergency care for acute alcohol intoxication (AAI) in Germany has sharply increased over the past years. Despite this, no randomized controlled trials (RCTs) have studied guideline- and evidence-based interventions to prevent future alcohol misuse within this population. The objective of our investigation was to evaluate the effectiveness of a brief motivational intervention (b-MI) to reduce drinking and associated problems within pediatric emergency departments (PED) in Hamburg, Germany. METHODS This stratified cluster-RCT compared a widely established but modified targeted b-MI and treatment as usual (TAU) for patients recruited and treated on Fridays, Saturdays, or Sundays from July 2011 to January 2014 for AAI in EDs of six pediatric hospitals in Hamburg, Germany. Patients under the age of 18 years and their caregivers were included in the study. Intervention was delivered by trained hospital-external staff. The intervention group (n = 141) received a single-session b-MI with a telephone booster after 6 weeks and a brief consultation for caregivers. All intervention material was manual-based. The TAU control group (n = 175) received youth-specific written information on alcohol use and contact information for community resources. Primary outcomes were changes in binge drinking frequency, number of alcoholic drinks on a typical occasion, and alcohol-related problems using the brief Rutgers Alcohol Problem Index. Outcomes were measured by research assistants not involved in intervention delivery. Baseline data were collected in person at the PED, and follow-up data were collected via telephone 3 and 6 months after baseline. Secondary outcome was postenrollment health service utilization. Analyses were based on linear mixed models and intent to treat. RESULTS A total of 86.1% (87.5%) of patients in the b-MI group and 82.4% (86.9%) in the TAU group provided valid outcome data after 3 (6) months, respectively. The differences between groups for all outcomes were statistically nonsignificant at both follow-ups (p > 0.05). After 3 months the mean change in binge drinking frequency was -1.36 (95% confidence interval [CI] = -1.81 to -0.91), a reduction of 62.1% in the b-MI group, and -1.29 (95% CI = -1.77 to -0.95), a reduction of 49.0% in the TAU group. The mean change in number of alcoholic drinks on a typical occasion was -2.24 (95% CI = -3.18 to -1.29), a reduction of 37.5% in the b-MI group, and -1.34 (95% CI = -2.54 to -0.14), a reduction of 26.4% in the TAU group. The mean change of alcohol-related problems was -6.72 (95% CI = -7.68 to -5.76), a reduction of 60.5% in the b-MI group, and -6.43 (95% CI = -7.37 to -5.49), a reduction of 58.3% in the TAU group. The differences in mean changes between groups were similar after 6 months for all outcomes. CONCLUSION This study provides new information on the effectiveness of b-MIs delivered at discharge of young AAI patients in emergency care. Both trial groups reduced alcohol use and related problems but the b-MI was not associated with significant effects. Although the intervention approach appears feasible, further considerations of improving the outcomes for this relevant target group are required.