Clinical trial NCT03019718: Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'
Official title: Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implementation
Keywords: Inpatient rehabilitation
Internet-based intervention
Aftercare
Return to work
Psychodynamic
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
name: Koblenz University of Applied Science
First posted: 2017-01-13
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Recommendation rate of 'GSA-Online plus'
timeFrame: study inclusion (T1)
measure: Number of patients participating in 'GSA-Online plus'
timeFrame: 12 weeks after study inclusion (T14)
Secondary outcomes:
measure: Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Working ability measured with the short form of the "Work Ability Index" (WAI)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Overall health status measured with the "EQ-5D-3L" questionnaire
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: General capability measured with the "Sheehan-Disability Scale"
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Loneliness measured with the "Loneliness Scale" (LS-S)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Psychological stress measured with the "Perceived Stress Scale" (PSS-4)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Personal resources measured with the "Oslo Support Scale" (OSS-3)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)
timeFrame: At study inclusion (T1) and 12 weeks later (T14)
measure: Regular Monitoring of self-rated health status
timeFrame: up to 12 weeks from study inclusion (T2-T13)
measure: Regular Monitoring of self-rated work ability
timeFrame: up to 12 weeks from study inclusion (T2-T13)
measure: Evaluation of the therapeutic feedback
timeFrame: up to 12 weeks from study inclusion (T2-T13)
measure: Evaluation of GSA-Online+
timeFrame: 12 weeks after study inclusion (T14)
measure: Willingness to pay
timeFrame: 12 weeks after study inclusion (T14)
Other outcomes:
Locations:
city: Bad Kreuznach
country: Germany
facility: Karl-Aschoff-Klinik
state: Rheinland-Pfalz
city: Bad Kreuznach
country: Germany
facility: Drei-Burgen-Klinik Bad Muenster am Stein
state: Rheinland-Pfalz
city: Boppard
country: Germany
facility: Mittelrheinklinik Bad Salzig
state: Rheinland-Pfalz
Study officials:
affiliation: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz
name: Manfred E. Beutel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.