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Self-Management for Anxiety, Depression and Somatoform Disorders (SMADS)

This study is currently recruiting participants.
Verified April 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01726387
First received: November 3, 2012
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Anxiety Depression (Mild or Not Persistent)
Major Depressive Disorder, Single Episode, Unspecified
Neurotic, Stress-related and Somatoform Disorders
 Behavioral: Psychosocial Counseling
Behavioral: Usual Care
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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."



Secondary Outcome Measures:
  • 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."



Other Outcome Measures:
  • 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)


Estimated Enrollment: 340
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Minimal Psychological Intervention
  • Self-Management Support
Placebo Comparator: Usual Care
Depending on the conditions, patients get usual care of their general practitioner.
 Behavioral: Usual Care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726387

Contacts
Contact: Martin Scherer, Prof. +49 40 7410 ext 52400 m.scherer@uke.de
Contact: Thomas Zimmermann, Dr. #49 40 7410 ext 56066 t.zimmermann@uke.de

Locations
Germany
Hausarztpraxis Quantz Recruiting
Hamburg, Germany
Contact: Sandra Quantz, MD     +49 40 7410 ext 52400     praxis@dr-quantz.de    
Principal Investigator: Patricia Thomsen, Study Nurse            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Martin Scherer, Prof. UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care
  More Information

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01726387     History of Changes
Other Study ID Numbers: SMADS
Study First Received: November 3, 2012
Last Updated: April 7, 2013
Health Authority: Germany: Ethics Commission (Hamburg Medical Association)

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Depressive Disorder, Major
Somatoform Disorders
 Dysthymic Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 16, 2013