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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Implementation Other: GSA-Online plus Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 31, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: GSA-Online plus
Patients receive access to the internet-based aftercare program after inpatient treatment.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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?

  2. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. Working ability measured with the short form of the "Work Ability Index" (WAI) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  3. Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  4. Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  5. Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  6. Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  7. Overall health status measured with the "EQ-5D-3L" questionnaire [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  8. General capability measured with the "Sheehan-Disability Scale" [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  9. Loneliness measured with the "Loneliness Scale" (LS-S) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  10. Psychological stress measured with the "Perceived Stress Scale" (PSS-4) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  11. Personal resources measured with the "Oslo Support Scale" (OSS-3) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  12. Personal resources measured with the "Brief Resilient Coping Scale" (BRCS) [ Time Frame: At study inclusion (T1) and 12 weeks later (T14) ]
  13. 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

  14. 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)

  15. 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.

  16. 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+

  17. 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+


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019718


Locations
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Germany
Karl-Aschoff-Klinik
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Drei-Burgen-Klinik Bad Muenster am Stein
Bad Kreuznach, Rheinland-Pfalz, Germany, 55583
Mittelrheinklinik Bad Salzig
Boppard, Rheinland-Pfalz, Germany, 56154
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Deutsche Rentenversicherung
Koblenz University of Applied Science
Investigators
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Principal Investigator: Manfred E. Beutel, Prof. Dr. University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Rüdiger Zwerenz, Principle Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT03019718    
Other Study ID Numbers: RK-93604
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz:
Inpatient rehabilitation
Internet-based intervention
Aftercare
Return to work
Psychodynamic