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Completed

NCT Number: NCT03019718

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

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).

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Key information

Conditions

Implementation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drei-Burgen-Klinik Bad Muenster am Stein, Bad Kreuznach, Rhineland-Palatinate, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSA-Online plus

Other

A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.

Primary outcomes

  1. 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?

  2. 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.

Secondary outcomes

  1. 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)

  2. Working ability measured with the short form of the "Work Ability Index" (WAI)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  3. Depressive symptoms measured with a subscale of the "Patient Health Questionnaire" (PHQ-9)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  4. Anxiety measured with the "General Anxiety Disorder Scale" (GAD-7)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  5. Somatic symptom burden measured with the Somatic Symptom Scale-8 (SSS-8)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  6. Psychosocial stressors measured with a subscale of the "Patient Health Questionnaire" (PHQ-10)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  7. Overall health status measured with the "EQ-5D-3L" questionnaire

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  8. General capability measured with the "Sheehan-Disability Scale"

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  9. Loneliness measured with the "Loneliness Scale" (LS-S)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  10. Psychological stress measured with the "Perceived Stress Scale" (PSS-4)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  11. Personal resources measured with the "Oslo Support Scale" (OSS-3)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  12. Personal resources measured with the "Brief Resilient Coping Scale" (BRCS)

    Time frame: At study inclusion (T1) and 12 weeks later (T14)

  13. Regular Monitoring of self-rated health status

    Time frame: 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

    Time frame: up to 12 weeks from study inclusion (T2-T13)

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

  15. Evaluation of the therapeutic feedback

    Time frame: 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+

    Time frame: 12 weeks after study inclusion (T14)

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

  17. Willingness to pay

    Time frame: 12 weeks after study inclusion (T14)

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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Deutsche Rentenversicherung
  • Koblenz University of Applied Science

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2017
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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