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History of Changes for Study: NCT03019718
Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'
Latest version (submitted March 2, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 10, 2017 None (earliest Version on record)
2 March 16, 2017 Study Status
3 August 15, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 March 2, 2018 Recruitment Status and Study Status
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Study NCT03019718
Submitted Date:  January 10, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: RK-93604
Brief Title: Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'
Official Title: Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Recruiting
Study Start: July 2016
Primary Completion: April 2017 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: January 6, 2017
First Submitted that
Met QC Criteria:
January 10, 2017
First Posted: January 13, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 10, 2017
Last Update Posted: January 13, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Johannes Gutenberg University Mainz
Responsible Party: Principal Investigator
Investigator: Dr. Rüdiger Zwerenz
Official Title: Principle Investigator
Affiliation: Johannes Gutenberg University Mainz
Collaborators: Deutsche Rentenversicherung
Koblenz University of Applied Science
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Implementation
Keywords: Inpatient rehabilitation
Internet-based intervention
Aftercare
Return to work
Psychodynamic
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 212 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GSA-Online plus
Patients receive access to the internet-based aftercare program after inpatient treatment.
GSA-Online plus
A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.
Open or close this module Outcome Measures
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+
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Ruediger Zwerenz, Dr.
Telephone: +49 6131 17 5981
Email: ruediger.zwerenz@unimedizin-mainz.de
Study Officials: Manfred E. Beutel, Prof. Dr.
Principal Investigator
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
Locations: Germany, Rheinland-Pfalz
Karl-Aschoff-Klinik
[Recruiting]
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Contact:Contact: Andreas Schwarting, Prof. Dr.
Drei-Burgen-Klinik Bad Muenster am Stein
[Recruiting]
Bad Kreuznach, Rheinland-Pfalz, Germany, 55583
Contact:Contact: Ute Dederichs-Masius, Dr.
Mittelrheinklinik Bad Salzig
[Recruiting]
Boppard, Rheinland-Pfalz, Germany, 56154
Contact:Contact: Frank Rudolph, Dr.
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links: Description: Online Aftercare Homepage
Available IPD/Information:

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