NCT03019718

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

January 6, 2017

Last Update Submit

March 2, 2018

Conditions

Implementation

Keywords

Inpatient rehabilitationInternet-based interventionAftercareReturn to workPsychodynamic

Outcome Measures

Primary Outcomes (2)

  • Recommendation rate of 'GSA-Online plus'

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

    study inclusion (T1)

  • 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 Outcomes (17)

  • Future prospects of employment measured with the "Subjective Prognosis of Work Ability Scale" (SPE)

    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)

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

    At study inclusion (T1) and 12 weeks later (T14)

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

    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)

  • +12 more secondary outcomes

Study Arms (1)

GSA-Online plus

EXPERIMENTAL

Patients receive access to the internet-based aftercare program after inpatient treatment.

Other: GSA-Online plus

Interventions

GSA-Online plusOTHER

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

GSA-Online plus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe psychiatric or somatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karl-Aschoff-Klinik

Bad Kreuznach, Rhineland-Palatinate, 55543, Germany

Location

Drei-Burgen-Klinik Bad Muenster am Stein

Bad Kreuznach, Rhineland-Palatinate, 55583, Germany

Location

Mittelrheinklinik Bad Salzig

Boppard, Rhineland-Palatinate, 56154, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29716605DERIVED

Related Links

Study Officials

  • Manfred E. Beutel, Prof. Dr.

    University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 13, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

October 31, 2017

Last Updated

March 5, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)