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

Implementation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019718
• Other study ID #: RK-93604
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: March 2, 2018
• Start date: July 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: March 2018
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). '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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 31, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Implementation

Intervention

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.

Locations

Country	Name	City	State
Germany	Drei-Burgen-Klinik Bad Muenster am Stein	Bad Kreuznach	Rheinland-Pfalz
Germany	Karl-Aschoff-Klinik	Bad Kreuznach	Rheinland-Pfalz
Germany	Mittelrheinklinik Bad Salzig	Boppard	Rheinland-Pfalz

Sponsors (3)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Deutsche Rentenversicherung, Koblenz University of Applied Science

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommendation rate of 'GSA-Online plus'	How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?	study inclusion (T1)
Primary	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.	12 weeks after study inclusion (T14)
Secondary	Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Working ability measured with the short form of the "Work Ability Index" (WAI)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Overall health status measured with the "EQ-5D-3L" questionnaire		At study inclusion (T1) and 12 weeks later (T14)
Secondary	General capability measured with the "Sheehan-Disability Scale"		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Loneliness measured with the "Loneliness Scale" (LS-S)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Psychological stress measured with the "Perceived Stress Scale" (PSS-4)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Personal resources measured with the "Oslo Support Scale" (OSS-3)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)		At study inclusion (T1) and 12 weeks later (T14)
Secondary	Regular Monitoring of self-rated health status	Item drawn from the "EQ-5D-3L" questionnaire	up to 12 weeks from study inclusion (T2-T13)
Secondary	Regular Monitoring of self-rated work ability	Item drawn from the "Work Ability Index" (WAI)	up to 12 weeks from study inclusion (T2-T13)
Secondary	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.	up to 12 weeks from study inclusion (T2-T13)
Secondary	Evaluation of GSA-Online+	Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+	12 weeks after study inclusion (T14)
Secondary	Willingness to pay	Self developed items if and how much money participants would pay for GSA-Online+	12 weeks after study inclusion (T14)

External Links

•   Online Aftercare Homepage