<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/NCT03019718</url>
  </required_header>
  <id_info>
    <org_study_id>RK-93604</org_study_id>
    <nct_id>NCT03019718</nct_id>
  </id_info>
  <brief_title>Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'</brief_title>
  <official_title>Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsche Rentenversicherung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Koblenz University of Applied Science</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to implement the internet-based aftercare program 'GSA-Online&#xD;
      plus' in several rehabilitation clinics with patients of different indications&#xD;
      (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an&#xD;
      internet-based aftercare program for patients with work-related problems or anxieties facing&#xD;
      return to work after longterm sickness absence and inpatient rehabilitation. The patients&#xD;
      have access to various exploratory and motivational videos on the study website until their&#xD;
      inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on&#xD;
      a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method&#xD;
      (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online&#xD;
      therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of&#xD;
      the intervention was determined, whereas the current study focuses on the implementation and&#xD;
      realization in a naturalistic setting (effectiveness).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recommendation rate of 'GSA-Online plus'</measure>
    <time_frame>study inclusion (T1)</time_frame>
    <description>How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients participating in 'GSA-Online plus'</measure>
    <time_frame>12 weeks after study inclusion (T14)</time_frame>
    <description>At least 66% of patients with a corresponding recommendation should use 'GSA-Online plus' at least once.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Future prospects of employment measured with the &quot;Subjective Prognosis of Work Ability Scale&quot; (SPE)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working ability measured with the short form of the &quot;Work Ability Index&quot; (WAI)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms measured with a subscale of the &quot;Patient Health Questionnaire&quot; (PHQ-9)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety measured with the &quot;General Anxiety Disorder Scale&quot; (GAD-7)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial stressors measured with a subscale of the &quot;Patient Health Questionnaire&quot; (PHQ-10)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall health status measured with the &quot;EQ-5D-3L&quot; questionnaire</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General capability measured with the &quot;Sheehan-Disability Scale&quot;</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness measured with the &quot;Loneliness Scale&quot; (LS-S)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological stress measured with the &quot;Perceived Stress Scale&quot; (PSS-4)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal resources measured with the &quot;Oslo Support Scale&quot; (OSS-3)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal resources measured with the &quot;Brief Resilient Coping Scale&quot; (BRCS)</measure>
    <time_frame>At study inclusion (T1) and 12 weeks later (T14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regular Monitoring of self-rated health status</measure>
    <time_frame>up to 12 weeks from study inclusion (T2-T13)</time_frame>
    <description>Item drawn from the &quot;EQ-5D-3L&quot; questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regular Monitoring of self-rated work ability</measure>
    <time_frame>up to 12 weeks from study inclusion (T2-T13)</time_frame>
    <description>Item drawn from the &quot;Work Ability Index&quot; (WAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the therapeutic feedback</measure>
    <time_frame>up to 12 weeks from study inclusion (T2-T13)</time_frame>
    <description>Two self developed items ('How satisfied are you with ... / How helpful was therapeutic feedback') on a five-point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of GSA-Online+</measure>
    <time_frame>12 weeks after study inclusion (T14)</time_frame>
    <description>Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to pay</measure>
    <time_frame>12 weeks after study inclusion (T14)</time_frame>
    <description>Self developed items if and how much money participants would pay for GSA-Online+</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Implementation</condition>
  <arm_group>
    <arm_group_label>GSA-Online plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive access to the internet-based aftercare program after inpatient treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GSA-Online plus</intervention_name>
    <description>A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.</description>
    <arm_group_label>GSA-Online plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referral (physician) or request (patient) to take part in the internet-based aftercare&#xD;
             program&#xD;
&#xD;
          -  Current or prospective employment within 4 weeks after inpatient rehabilitation&#xD;
&#xD;
          -  Private internet access&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Knowledge of the German language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric or somatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manfred E. Beutel, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karl-Aschoff-Klinik</name>
      <address>
        <city>Bad Kreuznach</city>
        <state>Rheinland-Pfalz</state>
        <zip>55543</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drei-Burgen-Klinik Bad Muenster am Stein</name>
      <address>
        <city>Bad Kreuznach</city>
        <state>Rheinland-Pfalz</state>
        <zip>55583</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mittelrheinklinik Bad Salzig</name>
      <address>
        <city>Boppard</city>
        <state>Rheinland-Pfalz</state>
        <zip>56154</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.online-nachsorge.de</url>
    <description>Online Aftercare Homepage</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 2, 2018</last_update_submitted>
  <last_update_submitted_qc>March 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Dr. Rüdiger Zwerenz</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Inpatient rehabilitation</keyword>
  <keyword>Internet-based intervention</keyword>
  <keyword>Aftercare</keyword>
  <keyword>Return to work</keyword>
  <keyword>Psychodynamic</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03019718
org study id: RK-93604
nct id: NCT03019718
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to implement the internet-based aftercare program 'GSA-Online
      plus' in several rehabilitation clinics with patients of different indications
      (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an
      internet-based aftercare program for patients with work-related problems or anxieties facing
      return to work after longterm sickness absence and inpatient rehabilitation. The patients
      have access to various exploratory and motivational videos on the study website until their
      inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on
      a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method
      (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online
      therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of
      the intervention was determined, whereas the current study focuses on the implementation and
      realization in a naturalistic setting (effectiveness).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recommendation rate of 'GSA-Online plus'
time frame: study inclusion (T1)
description: How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?
measure: Number of patients participating in 'GSA-Online plus'
time frame: 12 weeks after study inclusion (T14)
description: At least 66% of patients with a corresponding recommendation should use 'GSA-Online plus' at least once.
measure: Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Working ability measured with the short form of the "Work Ability Index" (WAI)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Overall health status measured with the "EQ-5D-3L" questionnaire
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: General capability measured with the "Sheehan-Disability Scale"
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Loneliness measured with the "Loneliness Scale" (LS-S)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Psychological stress measured with the "Perceived Stress Scale" (PSS-4)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Personal resources measured with the "Oslo Support Scale" (OSS-3)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)
time frame: At study inclusion (T1) and 12 weeks later (T14)
measure: Regular Monitoring of self-rated health status
time frame: up to 12 weeks from study inclusion (T2-T13)
description: Item drawn from the "EQ-5D-3L" questionnaire
measure: Regular Monitoring of self-rated work ability
time frame: up to 12 weeks from study inclusion (T2-T13)
description: Item drawn from the "Work Ability Index" (WAI)
measure: Evaluation of the therapeutic feedback
time frame: up to 12 weeks from study inclusion (T2-T13)
description: Two self developed items ('How satisfied are you with ... / How helpful was therapeutic feedback') on a five-point Likert scale.
measure: Evaluation of GSA-Online+
time frame: 12 weeks after study inclusion (T14)
description: Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+
measure: Willingness to pay
time frame: 12 weeks after study inclusion (T14)
description: Self developed items if and how much money participants would pay for GSA-Online+
arm group label: GSA-Online plus
arm group type: Experimental
description: Patients receive access to the internet-based aftercare program after inpatient treatment.
intervention type: Other
intervention name: GSA-Online plus
description: A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.
arm group label: GSA-Online plus
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Manfred E. Beutel, Prof. Dr.
role: Principal Investigator
affiliation: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
facility: 
facility: 
facility: 
country: Germany
url: http://www.online-nachsorge.de
description: Online Aftercare Homepage
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Dr. Rüdiger Zwerenz
investigator title: Principle Investigator
sharing ipd: No