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

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Completed
CT.gov ID
NCT03019718
Collaborator
Deutsche Rentenversicherung (Other), Koblenz University of Applied Science (Other)
88
3
1
16
29.3
1.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: GSA-Online plus
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of the Online Aftercare Intervention 'GSA-Online Plus' (Healthy and Without Stress at the Workplace)
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Oct 31, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Recommendation rate of 'GSA-Online plus' [study inclusion (T1)]

    How often will 'GSA-Online plus' be recommended as an aftercare after inpatient rehabilitation?

  2. 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

  1. Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE) [At study inclusion (T1) and 12 weeks later (T14)]

  2. Working ability measured with the short form of the "Work Ability Index" (WAI) [At study inclusion (T1) and 12 weeks later (T14)]

  3. Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9) [At study inclusion (T1) and 12 weeks later (T14)]

  4. Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7) [At study inclusion (T1) and 12 weeks later (T14)]

  5. Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8) [At study inclusion (T1) and 12 weeks later (T14)]

  6. Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10) [At study inclusion (T1) and 12 weeks later (T14)]

  7. Overall health status measured with the "EQ-5D-3L" questionnaire [At study inclusion (T1) and 12 weeks later (T14)]

  8. General capability measured with the "Sheehan-Disability Scale" [At study inclusion (T1) and 12 weeks later (T14)]

  9. Loneliness measured with the "Loneliness Scale" (LS-S) [At study inclusion (T1) and 12 weeks later (T14)]

  10. Psychological stress measured with the "Perceived Stress Scale" (PSS-4) [At study inclusion (T1) and 12 weeks later (T14)]

  11. Personal resources measured with the "Oslo Support Scale" (OSS-3) [At study inclusion (T1) and 12 weeks later (T14)]

  12. Personal resources measured with the "Brief Resilient Coping Scale" (BRCS) [At study inclusion (T1) and 12 weeks later (T14)]

  13. Regular Monitoring of self-rated health status [up to 12 weeks from study inclusion (T2-T13)]

    Item drawn from the "EQ-5D-3L" questionnaire

  14. Regular Monitoring of self-rated work ability [up to 12 weeks from study inclusion (T2-T13)]

    Item drawn from the "Work Ability Index" (WAI)

  15. 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.

  16. Evaluation of GSA-Online+ [12 weeks after study inclusion (T14)]

    Self developed items to assess overall satisfaction with, helpfulness and utilization of GSA-Online+

  17. Willingness to pay [12 weeks after study inclusion (T14)]

    Self developed items if and how much money participants would pay for GSA-Online+

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karl-Aschoff-Klinik Bad Kreuznach Rheinland-Pfalz Germany 55543
2 Drei-Burgen-Klinik Bad Muenster am Stein Bad Kreuznach Rheinland-Pfalz Germany 55583
3 Mittelrheinklinik Bad Salzig Boppard Rheinland-Pfalz Germany 56154

Sponsors and Collaborators

  • Johannes Gutenberg University Mainz
  • Deutsche Rentenversicherung
  • Koblenz University of Applied Science

Investigators

  • Principal Investigator: Manfred E. Beutel, Prof. Dr., University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dr. RĂ¼diger Zwerenz, Principle Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT03019718
Other Study ID Numbers:
  • RK-93604
First Posted:
Jan 13, 2017
Last Update Posted:
Mar 5, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Dr. RĂ¼diger Zwerenz, Principle Investigator, Johannes Gutenberg University Mainz

Study Results

No Results Posted as of Mar 5, 2018