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

March 2, 2018 updated by: Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz

Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
        • Karl-Aschoff-Klinik
      • Bad Kreuznach, Rheinland-Pfalz, Germany, 55583
        • Drei-Burgen-Klinik Bad Muenster am Stein
      • Boppard, Rheinland-Pfalz, Germany, 56154
        • Mittelrheinklinik Bad Salzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
study inclusion (T1)
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.
12 weeks after study inclusion (T14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
up to 12 weeks from study inclusion (T2-T13)
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)
up to 12 weeks from study inclusion (T2-T13)
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.
up to 12 weeks from study inclusion (T2-T13)
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+
12 weeks after study inclusion (T14)
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+
12 weeks after study inclusion (T14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

Deutsche Rentenversicherung
Koblenz University of Applied Science

Investigators

  • Principal Investigator: Manfred E. Beutel, Prof. Dr., University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RK-93604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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