ImplementationNCT03019718
Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'
A study testing GSA-Online plus in people with Implementation, run by Johannes Gutenberg University Mainz at 3 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implementation
- What is being tested?
- GSA-Online plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2016to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe psychiatric or somatic disease
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Karl-Aschoff-Klinik
Bad Kreuznach, Rhineland-Palatinate, 55543
Drei-Burgen-Klinik Bad Muenster am Stein
Bad Kreuznach, Rhineland-Palatinate, 55583
Mittelrheinklinik Bad Salzig
Boppard, Rhineland-Palatinate, 56154
About this study
Official title: 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).
- Conditions
- Implementation
- Being tested
- GSA-Online plus
- Keywords
- Inpatient rehabilitation, Internet-based intervention, Aftercare, Return to work, Psychodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSA-Online plusOther
A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.
| Study group | Role | What they receive |
|---|---|---|
| GSA-Online plus | Experimental | Patients receive access to the internet-based aftercare program after inpatient treatment. Receives: Other: GSA-Online plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommendation rate of 'GSA-Online plus'
How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?
Measured: study inclusion (T1)
Number of patients participating in 'GSA-Online plus'
At least 66% of patients with a corresponding recommendation should use 'GSA-Online plus' at least once.
Measured: 12 weeks after study inclusion (T14)
Secondary outcomes (17)
Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Working ability measured with the short form of the "Work Ability Index" (WAI)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Overall health status measured with the "EQ-5D-3L" questionnaire
Measured: At study inclusion (T1) and 12 weeks later (T14)
General capability measured with the "Sheehan-Disability Scale"
Measured: At study inclusion (T1) and 12 weeks later (T14)
Loneliness measured with the "Loneliness Scale" (LS-S)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Psychological stress measured with the "Perceived Stress Scale" (PSS-4)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Personal resources measured with the "Oslo Support Scale" (OSS-3)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)
Measured: At study inclusion (T1) and 12 weeks later (T14)
Regular Monitoring of self-rated health status
Item drawn from the "EQ-5D-3L" questionnaire
Measured: up to 12 weeks from study inclusion (T2-T13)
Regular Monitoring of self-rated work ability
Item drawn from the "Work Ability Index" (WAI)
Measured: up to 12 weeks from study inclusion (T2-T13)
Evaluation of the therapeutic feedback
Two self developed items ('How satisfied are you with ... / How helpful was therapeutic feedback') on a five-point Likert scale.
Measured: up to 12 weeks from study inclusion (T2-T13)
Evaluation of GSA-Online+
Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+
Measured: 12 weeks after study inclusion (T14)
Willingness to pay
Self developed items if and how much money participants would pay for GSA-Online+
Measured: 12 weeks after study inclusion (T14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Rentenversicherung, Koblenz University of Applied Science
- Responsible party
- Principal investigator, Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz
- Investigators
- Manfred E. Beutel, Prof. Dr., Principal investigator, University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019718
- Sponsor's protocol ID
- RK-93604
- Status last verified
- Mar 2018
- First submitted
- 6 Jan 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zwerenz R, Bohme 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.
PubMed 29716605
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
- ClinicalTrials.gov ID
- NCT03019718
- Acronym / sponsor ID
- RK-93604
- Conditions
- Implementation
- Keywords
- Inpatient rehabilitation, Internet-based intervention, Aftercare, Return to work, Psychodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Deutsche Rentenversicherung, Koblenz University of Applied Science
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSA-Online plus | Experimental | Other: GSA-Online plusPatients receive access to the internet-based aftercare program after inpatient treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Severe psychiatric or somatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSA-Online plusA 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists. | Other | GSA-Online plus |
Primary outcome
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.
17 secondary outcomes
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)
Regular Monitoring of self-rated work ability
Time frame: 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)
Evaluation of GSA-Online+
Time frame: 12 weeks after study inclusion (T14)
Willingness to pay
Time frame: 12 weeks after study inclusion (T14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Derived from this study: PubMed 29716605Zwerenz R, Bohme 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.
- Online Aftercare HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred E. Beutel, Prof. Dr. principal investigator
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSA-Online plus in people with Implementation, run by Johannes Gutenberg University Mainz at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommendation rate of 'GSA-Online plus' (time frame: study inclusion (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.