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

Not Applicable

Completed

• Conditions: Implementation
• Interventions: Other: GSA-Online plus

• Registration Number: NCT03019718
• Lead Sponsor: Johannes Gutenberg University Mainz

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

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-13
• Primary Completion: 2017-07
• Study Completion: 2017-10-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GSA-Online plus	GSA-Online plus	Patients receive access to the internet-based aftercare program after inpatient treatment.

Primary Outcome Measures

Name	Time	Method
Recommendation rate of 'GSA-Online plus'	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'	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

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

Trial Locations

Locations (3)

Karl-Aschoff-Klinik; 🇩🇪 Bad Kreuznach, Rheinland-Pfalz, Germany

Drei-Burgen-Klinik Bad Muenster am Stein; 🇩🇪 Bad Kreuznach, Rheinland-Pfalz, Germany

Mittelrheinklinik Bad Salzig; 🇩🇪 Boppard, Rheinland-Pfalz, Germany