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Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'

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ClinicalTrials.gov Identifier: NCT03019718
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Deutsche Rentenversicherung
Koblenz University of Applied Science
Information provided by (Responsible Party):
Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 13, 2017
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Recommendation rate of 'GSA-Online plus' [ Time Frame: study inclusion (T1) ]
    How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?
  • Number of patients participating in 'GSA-Online plus' [ Time Frame: 12 weeks after study inclusion (T14) ]
    At least 66% of patients with a corresponding recommendation should use 'GSA-Online plus' at least once.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • 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) ]
  • Working ability measured with the short form of the "Work Ability Index" (WAI) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Overall health status measured with the "EQ-5D-3L" questionnaire [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • General capability measured with the "Sheehan-Disability Scale" [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Loneliness measured with the "Loneliness Scale" (LS-S) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Psychological stress measured with the "Perceived Stress Scale" (PSS-4) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Personal resources measured with the "Oslo Support Scale" (OSS-3) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Personal resources measured with the "Brief Resilient Coping Scale" (BRCS) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  • Regular Monitoring of self-rated health status [ Time Frame: up to 12 weeks from study inclusion (T2-T13) ]
    Item drawn from the "EQ-5D-3L" questionnaire
  • Regular Monitoring of self-rated work ability [ Time Frame: up to 12 weeks from study inclusion (T2-T13) ]
    Item drawn from the "Work Ability Index" (WAI)
  • Evaluation of the therapeutic feedback [ Time Frame: up to 12 weeks from study inclusion (T2-T13) ]
    Two self developed items ('How satisfied are you with ... / How helpful was therapeutic feedback') on a five-point Likert scale.
  • Evaluation of GSA-Online+ [ Time Frame: 12 weeks after study inclusion (T14) ]
    Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+
  • Willingness to pay [ Time Frame: 12 weeks after study inclusion (T14) ]
    Self developed items if and how much money participants would pay for GSA-Online+
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'
Official Title  ICMJE Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Implementation
Intervention  ICMJE Other: GSA-Online plus
A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.
Study Arms  ICMJE Experimental: GSA-Online plus
Patients receive access to the internet-based aftercare program after inpatient treatment.
Intervention: Other: GSA-Online plus
Publications * Zwerenz R, Böhme K, Wirth A, Labitzke N, Pachtchenko S, Beutel ME. Integration of the work-related online aftercare intervention 'GSA-online plus' (healthy and without stress at the workplace) into clinical practice: study protocol for an implementation study. BMC Health Serv Res. 2018 May 2;18(1):312. doi: 10.1186/s12913-018-2995-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
88
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2017)
212
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Referral (physician) or request (patient) to take part in the internet-based aftercare program
  • Current or prospective employment within 4 weeks after inpatient rehabilitation
  • Private internet access
  • Informed consent
  • Knowledge of the German language

Exclusion Criteria:

  • Severe psychiatric or somatic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03019718
Other Study ID Numbers  ICMJE RK-93604
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE
  • Deutsche Rentenversicherung
  • Koblenz University of Applied Science
Investigators  ICMJE
Principal Investigator: Manfred E. Beutel, Prof. Dr. University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP