<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726387</url>
  </required_header>
  <id_info>
    <org_study_id>SMADS</org_study_id>
    <nct_id>NCT01726387</nct_id>
  </id_info>
  <brief_title>Self-Management for Anxiety, Depression and Somatoform Disorders</brief_title>
  <acronym>SMADS</acronym>
  <official_title>Self-Management Support in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often&#xD;
      these conditions remain undiscovered and/or untreated.&#xD;
&#xD;
      In order to ease this urgent health care problem in the future, the investigators conduct a&#xD;
      cluster-randomized controlled trial, implementing a tandem working cooperation between a&#xD;
      nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its&#xD;
      own practise.&#xD;
&#xD;
      The CA's task is to enhance the patients abilities to engage in a better self-management of&#xD;
      their psychological symptoms and complaints, to enhance self-efficacy and empower the&#xD;
      patients to tackle problems of daily living.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often&#xD;
      these conditions remain undiscovered and/or untreated. Managing it is time-consuming and&#xD;
      communication-intensive. Furthermore, the management is restraint by the high&#xD;
      contact-frequencies in primary care practices in Germany.&#xD;
&#xD;
      In order to ease this urgent health care problem in the future, the investigators conduct a&#xD;
      cluster-randomized controlled trial, implementing a tandem working cooperation between a&#xD;
      nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its&#xD;
      own practise.&#xD;
&#xD;
      The CA's task is to enhance the patients abilities to engage in a better self-management of&#xD;
      their psychological symptoms and complaints, to enhance self-efficacy and empower the&#xD;
      patients to tackle problems of daily living.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>General Self-Efficacy Scale (GSE)</measure>
    <time_frame>Baseline, 8 Weeks, 12 Months</time_frame>
    <description>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.&#xD;
http://userpage.fu-berlin.de/%7Ehealth/engscal.htm &quot;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.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Symptom Score Patient's Health Questionnaire (German Version)</measure>
    <time_frame>Baseline, 8 Weeks, 12 Months</time_frame>
    <description>Reducing the symptoms score in the &quot;Patient's Health Questionnaire (German Version)&quot;. 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>Baseline, 8 Weeks, 12 Months</time_frame>
    <description>Enhancing the health related quality of life in the patients using EQ-5D&#xD;
http://www.euroqol.org/ EQ-5D (European-Quality-of-Life-5-Dimensions): &quot;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.&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Coping with Illness scale</measure>
    <time_frame>Baseline, 8 Weeks, 12 Months</time_frame>
    <description>Assesses a broad range of cognitive, behavioral and emotional aspects of coping with illness. Investigators use the short version (FKV-LIS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">364</enrollment>
  <condition>Anxiety Depression (Mild or Not Persistent)</condition>
  <condition>Major Depressive Disorder, Single Episode, Unspecified</condition>
  <condition>Neurotic, Stress-related and Somatoform Disorders</condition>
  <arm_group>
    <arm_group_label>Psychosocial Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Depending on the conditions, patients get usual care of their general practitioner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Counseling</intervention_name>
    <description>Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms</description>
    <arm_group_label>Psychosocial Counseling</arm_group_label>
    <other_name>Minimal Psychological Intervention</other_name>
    <other_name>Self-Management Support</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Depending on the conditions, patients get usual care of their general practitioner</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scoring &gt;= 5 on the Patient Health Questionnaire (German Version),&#xD;
             corresponding to a probable or established diagnosis of Anxiety, Depression or&#xD;
             Somatoform Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negation of Inclusion Criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Scherer, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Care Practices</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Zimmermann T, Puschmann E, Ebersbach M, Daubmann A, Steinmann S, Scherer M. Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial. BMC Psychiatry. 2014 Jan 3;14:2. doi: 10.1186/1471-244X-14-2.</citation>
    <PMID>24387048</PMID>
  </reference>
  <reference>
    <citation>Zimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012.</citation>
  </reference>
  <reference>
    <citation>Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen T, Scherer M. Selbstmanagementförderung in der ambulanten Versorgung. Programm einer niedrigschwelligen, komplexen, psychosozialen Intervention durch Pflegekräfte in der Hausarztpraxis. Zeitschrift für Allgemeinmedizin, 91, 11, 456-462, 2015.</citation>
  </reference>
  <reference>
    <citation>Porzelt S, Zimmermann T, Ernst A, Puschmann E, Scherer M. Wie Pflegekräfte in der hausärztlichen Versorgung Patienten mit psychischen Beschwerden gezielt unterstützen können. Pflegewissenschaft, 18(7-8): 355-361, 2016.</citation>
  </reference>
  <results_reference>
    <citation>Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen P, Scherer M. [Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. Psychiatr Prax. 2015 Jul;42 Suppl 1:S44-8. doi: 10.1055/s-0034-1387686. Epub 2015 Jul 2. German.</citation>
    <PMID>26135280</PMID>
  </results_reference>
  <results_reference>
    <citation>Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, Daubmann A, Scherer M. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study). Int J Nurs Stud. 2016 Nov;63:101-111. doi: 10.1016/j.ijnurstu.2016.08.007. Epub 2016 Aug 21.</citation>
    <PMID>27611093</PMID>
  </results_reference>
  <results_reference>
    <citation>Grochtdreis T, Zimmermann T, Puschmann E, Porzelt S, Dams J, Scherer M, Konig HH. Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial). Int J Nurs Stud. 2018 Apr;80:67-75. doi: 10.1016/j.ijnurstu.2017.12.010. Epub 2017 Dec 29.</citation>
    <PMID>29353712</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726387
org study id: SMADS
nct id: NCT01726387
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: General Self-Efficacy Scale (GSE)
time frame: Baseline, 8 Weeks, 12 Months
description: 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."
measure: Change in Symptom Score Patient's Health Questionnaire (German Version)
time frame: Baseline, 8 Weeks, 12 Months
description: 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.
measure: Health Related Quality of Life
time frame: Baseline, 8 Weeks, 12 Months
description: 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."
measure: Coping with Illness scale
time frame: Baseline, 8 Weeks, 12 Months
description: Assesses a broad range of cognitive, behavioral and emotional aspects of coping with illness. Investigators use the short version (FKV-LIS)
arm group label: Psychosocial Counseling
arm group type: Experimental
description: 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.
arm group label: Usual Care
arm group type: Placebo Comparator
description: Depending on the conditions, patients get usual care of their general practitioner.
intervention type: Behavioral
intervention name: Psychosocial Counseling
description: Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms
arm group label: Psychosocial Counseling
other name: Minimal Psychological Intervention
other name: Self-Management Support
intervention type: Behavioral
intervention name: Usual Care
description: Depending on the conditions, patients get usual care of their general practitioner
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Martin Scherer, Prof.
role: Principal Investigator
affiliation: UK Hamburg-Eppendorf (Germany), Department of Primary Medical Care
facility: 
country: Germany
citation: Zimmermann T, Puschmann E, Ebersbach M, Daubmann A, Steinmann S, Scherer M. Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial. BMC Psychiatry. 2014 Jan 3;14:2. doi: 10.1186/1471-244X-14-2.
PMID: 24387048
citation: Zimmermann T, Puschmann E, Bäter G, Carstens S, Scherer M. Selbstmanagement stärken bei psychosozialen Belastungen. Die Kerbe - Forum für soziale Psychiatrie 4, 24-26, 2012.
citation: Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen T, Scherer M. Selbstmanagementförderung in der ambulanten Versorgung. Programm einer niedrigschwelligen, komplexen, psychosozialen Intervention durch Pflegekräfte in der Hausarztpraxis. Zeitschrift für Allgemeinmedizin, 91, 11, 456-462, 2015.
citation: Porzelt S, Zimmermann T, Ernst A, Puschmann E, Scherer M. Wie Pflegekräfte in der hausärztlichen Versorgung Patienten mit psychischen Beschwerden gezielt unterstützen können. Pflegewissenschaft, 18(7-8): 355-361, 2016.
citation: Zimmermann T, Puschmann E, Porzelt S, Ebersbach M, Ernst A, Thomsen P, Scherer M. [Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention]. Psychiatr Prax. 2015 Jul;42 Suppl 1:S44-8. doi: 10.1055/s-0034-1387686. Epub 2015 Jul 2. German.
PMID: 26135280
citation: Zimmermann T, Puschmann E, van den Bussche H, Wiese B, Ernst A, Porzelt S, Daubmann A, Scherer M. Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study). Int J Nurs Stud. 2016 Nov;63:101-111. doi: 10.1016/j.ijnurstu.2016.08.007. Epub 2016 Aug 21.
PMID: 27611093
citation: Grochtdreis T, Zimmermann T, Puschmann E, Porzelt S, Dams J, Scherer M, Konig HH. Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial). Int J Nurs Stud. 2018 Apr;80:67-75. doi: 10.1016/j.ijnurstu.2017.12.010. Epub 2017 Dec 29.
PMID: 29353712
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Somatoform Disorders
sharing ipd: Undecided