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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. Managing it is time-consuming and communication-intensive. Furthermore, the management is restraint by the high contact-frequencies in primary care practices in Germany.
In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.
The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial Counseling | Experimental | A Counseling Assistant offers a low-threshold intervention (self-management support, counseling, active guidance). This nurse practitioner collaborates extensively with the general practitioner, re-adjusting the intervention in order to meet the patient's needs. |
|
| Usual Care | Placebo Comparator | Depending on the conditions, patients get usual care of their general practitioner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Counseling | Behavioral | Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| General Self-Efficacy Scale (GSE) | GSE assesses a general sense of perceived self-efficacy. It predicts coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. http://userpage.fu-berlin.de/%7Ehealth/engscal.htm "The construct of Perceived Self-Efficacy reflects an optimistic self-belief (Schwarzer, 1992). This is the belief that one can perform a novel or difficult tasks, or cope with adversity -- in various domains of human functioning. Perceived self-efficacy facilitates goal-setting, effort investment, persistence in face of barriers and recovery from setbacks. It can be regarded as a positive resistance resource factor. Ten items are designed to tap this construct. Each item refers to successful coping and implies an internal-stable attribution of success. Perceived self-efficacy is an operative construct, i.e., it is related to subsequent behavior and, therefore, is relevant for clinical practice and behavior change." | Baseline, 8 Weeks, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptom Score Patient's Health Questionnaire (German Version) | Reducing the symptoms score in the "Patient's Health Questionnaire (German Version)". Reducing symptom score per scale -2,5 units comparing group mean of the intervention group and the group mean of the control group, power 80%, probability 0,05. Effect size d=0,5. | Baseline, 8 Weeks, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Coping with Illness scale | Assesses a broad range of cognitive, behavioral and emotional aspects of coping with illness. Investigators use the short version (FKV-LIS) | Baseline, 8 Weeks, 12 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Scherer, Prof. | UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Practices | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24387048 | Background | Zimmermann T, Puschmann E, Ebersbach M, Daubmann A, Steinmann S, Scherer M. 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. BMC Psychiatry. 2014 Jan 3;14:2. doi: 10.1186/1471-244X-14-2. | |
| Background | Zimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012. | ||
| Background | Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen T, Scherer M. Selbstmanagementförderung in der ambulanten Versorgung. Programm einer niedrigschwelligen, komplexen, psychosozialen Intervention durch Pflegekräfte in der Hausarztpraxis. Zeitschrift für Allgemeinmedizin, 91, 11, 456-462, 2015. | ||
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D003865 | Depressive Disorder, Major |
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Usual Care | Behavioral | Depending on the conditions, patients get usual care of their general practitioner |
|
| Health Related Quality of Life | Enhancing the health related quality of life in the patients using EQ-5D http://www.euroqol.org/ EQ-5D (European-Quality-of-Life-5-Dimensions): "Descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension." | Baseline, 8 Weeks, 12 Months |
| Background |
| Porzelt S, Zimmermann T, Ernst A, Puschmann E, Scherer M. Wie Pflegekräfte in der hausärztlichen Versorgung Patienten mit psychischen Beschwerden gezielt unterstützen können. Pflegewissenschaft, 18(7-8): 355-361, 2016. |
| 26135280 | Result | Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen P, Scherer M. [Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. Psychiatr Prax. 2015 Jul;42 Suppl 1:S44-8. doi: 10.1055/s-0034-1387686. Epub 2015 Jul 2. German. |
| 27611093 | Result | Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, Daubmann A, Scherer M. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study). Int J Nurs Stud. 2016 Nov;63:101-111. doi: 10.1016/j.ijnurstu.2016.08.007. Epub 2016 Aug 21. |
| 29353712 | Result | Grochtdreis T, Zimmermann T, Puschmann E, Porzelt S, Dams J, Scherer M, Konig HH. Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial). Int J Nurs Stud. 2018 Apr;80:67-75. doi: 10.1016/j.ijnurstu.2017.12.010. Epub 2017 Dec 29. |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |