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

This study is ongoing, but not recruiting participants.
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: July 11, 2014
Last verified: July 2014
  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
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 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:


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: June 2015
Estimated Primary Completion Date: June 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Primary Care Practices
Hamburg, Germany
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

Publications:
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: July 11, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 15, 2014