Anxiety Depression (Mild or Not Persistent), Major Depressive Disorder, Single Episode, Unspecified, Neurotic, Stress-related and Somatoform Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPsychosocial Counseling
Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms
BEHAVIORALUsual Care
Depending on the conditions, patients get usual care of their general practitioner
Sponsors
German Federal Ministry of Education and Research
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scoring \>= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder
Exclusion criteria
* Negation of Inclusion Criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Self-Efficacy Scale (GSE) | Baseline, 8 Weeks, 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Score Patient's Health Questionnaire (German Version) | Baseline, 8 Weeks, 12 Months | 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. |
| Health Related Quality of Life | Baseline, 8 Weeks, 12 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Coping with Illness scale | Baseline, 8 Weeks, 12 Months | Assesses a broad range of cognitive, behavioral and emotional aspects of coping with illness. Investigators use the short version (FKV-LIS) |
Countries
Germany
Outcome results
None listed