Self-Management for Anxiety, Depression and Somatoform Disorders (SMADS)
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.
Anxiety Depression (Mild or Not Persistent)
Major Depressive Disorder, Single Episode, Unspecified
Neurotic, Stress-related and Somatoform Disorders
Behavioral: Psychosocial Counseling
Behavioral: Usual Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Self-Management Support in Primary Care|
- General Self-Efficacy Scale (GSE) [ Time Frame: Baseline, 8 Weeks, 12 Months ] [ Designated as safety issue: No ]
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."
- Change in Symptom Score Patient's Health Questionnaire (German Version) [ Time Frame: Baseline, 8 Weeks, 12 Months ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 Weeks, 12 Months ] [ Designated as safety issue: No ]
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."
- Coping with Illness scale [ Time Frame: Baseline, 8 Weeks, 12 Months ] [ Designated as safety issue: No ]Assesses a broad range of cognitive, behavioral and emotional aspects of coping with illness. Investigators use the short version (FKV-LIS)
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Psychosocial Counseling
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.
Behavioral: Psychosocial Counseling
Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms
Placebo Comparator: Usual Care
Depending on the conditions, patients get usual care of their general practitioner.
|Behavioral: Usual Care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726387
|Primary Care Practices|
|Principal Investigator:||Martin Scherer, Prof.||UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care|