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

February 2, 2018 updated by: Universitätsklinikum Hamburg-Eppendorf

Self-Management Support in Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Primary Care Practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Depending on the conditions, patients get usual care of their general practitioner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Self-Efficacy Scale (GSE)
Time Frame: 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."
Baseline, 8 Weeks, 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom Score Patient's Health Questionnaire (German Version)
Time Frame: 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.
Baseline, 8 Weeks, 12 Months
Health Related Quality of Life
Time Frame: 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."
Baseline, 8 Weeks, 12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping with Illness scale
Time Frame: 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)
Baseline, 8 Weeks, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Martin Scherer, Prof., UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 3, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMADS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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