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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johannes Gutenberg University Mainz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche Rentenversicherung
Koblenz University of Applied Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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