Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare

Mental Disorder Clinical Trial

Official title:

Studies on the Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare According to the Hannover Curriculum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989842
• Other study ID #: Curriculum Hannover Online
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Dr. Becker Hospital Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy.

In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy.

Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation.

Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online).

The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.

Description:

The use of information and communication technology with the aim of promoting mental health can be described as "e-Mental Health", which is regularly used synonymously with the term "internet-based interventions".

With regard to the study situation on internet-based aftercare interventions, especially in Germany, the research is in an early phase. An overview of the possible uses of internet-based treatment approaches in rehabilitation can be found in Lin, Ebert, Lehr, Berking and Baumeister (2013) and - based on the contributions of the Rehabilitation Science Colloquium since 2008 - Baumeister, Lin and Ebert (2013). However, the first randomised controlled studies on aftercare show, in agreement with the studies outlined above, that corresponding offers led to a reduction in relapses compared to Care as Usual (CAU) (Bauer, Okon, Meermann, Kordy, 2013; Ebert, Tarnowski, Gollwitzer, Sieland& Berking, 2013).Both interventions represent new conceptual developments. Regarding the positive findings on the effectiveness of internet-based interventions and with a view to the suboptimal care situation, Kobelt, Winkler and Petermann (2011), for example, recommend the expansion of internet-based aftercare services and their evaluation.

The planned project aims to develop an internet-based variant of the aftercare concept Curriculum Hannover (Curriculum-Hannover-Online), to integrate it into routine care and to test its effectiveness. The technology of the virtual classroom is particularly suitable for internet-based interventions providing group therapy (cf. Wolever et al., 2012).

For this purpose, the existing manual for Curriculum Hannover (cf. Kobelt et al., 2002) is adapted in the course of the process for the needs of an online intervention. The therapists will be prepared for the specifics of the medium through a train-the-trainer-training for learning how to specifically establish and maintain a therapeutic relationship between therapist and participants. It is assumed that this new program for outpatient aftercare after inpatient psychosomatic rehabilitation can be an effective and useful therpy for patients who do not have access to the existing face-to-face aftercare therapies.. The Virtual Classroom is a direct, video- or audio-synchronous and multimedia contact between therapist and patient.

The main question of the superiority study is:

A. Does participation in the Curriculum-Hannover-Online lead to improved uptake and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online be designed in such a way that its use as a routine procedure in rehabilitation can be recommended? C. Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? For the successful introduction of a new treatment approach, in addition to the proof of its effectiveness, significant challenges have to be overcome with regard to the organisation of work processes, the involvement of all actors involved in the process (especially patients, practitioners, management).

The main question of the equivalence study is:

A.Does participation in the Curriculum-Hannover-Online lead to an equivalent adoption and maintenance of the health improvements achieved in inpatient rehabilitation? B. Can the implementation of the Curriculum-Hannover-Online in addition to the offer of the face-to-face variant be designed in such a way that its use as a rou- tine procedure in rehabilitation can be recommended? C.Can the Curriculum-Hannover-Online be accepted by the relevant stakeholders to the same extent as the face-to-face version of the Curriculum-Hannover-Online? D.Can characteristics be identified that allow a differential indication for the recommendation to participate in the Curriculum Hannover in its online or face-to-face variant? E.What are the additional advantages of the Curriculum Hannover Online from the perspective of patients, therapists, service providers and health care providers? Both studies will be conducted as two-arm randomised controlled trials. Individual rehabilitation patients will be randomised to the respective study arms. The system is based on a randomisation list (permuted blocks of variable length) with the help of the "Randlist" software at the sites. The order of the completed questionnaires determines the position in the list.

All data of the participants will be treated in accordance with the data security regulations (DSGVO), good scientific practice and the ethical requirements. Furthermore, all patients are informed about the project, ethics and data protection in a generally understandable way by a cover letter from their clinic before the treatment. All project staff are obliged to comply with the ethics guidelines and to maintain confidentiality. The pre- and post-data of the patients are combined by means of a personal code, which does not allow any conclusion about the participant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6023
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients after psychosomatic rehabilitation

• indication for outpatient psychosomatic aftercare are included in both studies.

• access to a standard PC and broadband internet connection is required (DSL or LTE).

Exclusion Criteria:

Persons who are

• are discharged with a capacity of less than three hours per day on the general labour market,

• receive or have applied for a pension of at least two-thirds of the full pension,

• receive a benefit that is regularly paid until the start of an old-age pension.

• suffering from acute addiction disorder / acute psychosis

Related Conditions & MeSH terms

• Disease
• Mental Disorder
• Mental Disorders
• Psychophysiologic Disorders
• Psychosomatic Disorder
• Somatoform Disorders

Intervention

Behavioral:
• Curriculum Hannover
The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of a face-to-face or a digital psychosomatic aftercare basing upon the concept of the Curriculum Hanover. A control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).

Locations

Country	Name	City	State
Germany	Dr. Becker Hospital Group	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Becker Hospital Group

Country where clinical trial is conducted

Germany, 

References & Publications (12)

Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/wps.20151. — View Citation

Arnberg FK, Linton SJ, Hultcrantz M, Heintz E, Jonsson U. Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness. PLoS One. 2014 May 20;9(5):e98118. doi: 10.1371/journal.pone.0098118. eCollection 2014. Review. — View Citation

Cheng SK, Dizon J. Computerised cognitive behavioural therapy for insomnia: a systematic review and meta-analysis. Psychother Psychosom. 2012;81(4):206-16. doi: 10.1159/000335379. Epub 2012 May 11. Review. — View Citation

Cuijpers P, Marks IM, van Straten A, Cavanagh K, Gega L, Andersson G. Computer-aided psychotherapy for anxiety disorders: a meta-analytic review. Cogn Behav Ther. 2009;38(2):66-82. doi: 10.1080/16506070802694776. Review. — View Citation

Cuijpers P, van Straten A, Warmerdam L, van Rooy MJ. Recruiting participants for interventions to prevent the onset of depressive disorders: possible ways to increase participation rates. BMC Health Serv Res. 2010 Jun 25;10:181. doi: 10.1186/1472-6963-10-181. — View Citation

Ebert D, Tarnowski T, Gollwitzer M, Sieland B, Berking M. A transdiagnostic internet-based maintenance treatment enhances the stability of outcome after inpatient cognitive behavioral therapy: a randomized controlled trial. Psychother Psychosom. 2013;82(4):246-56. doi: 10.1159/000345967. Epub 2013 Jun 1. — View Citation

Ebert DD, Lehr D, Boß L, Riper H, Cuijpers P, Andersson G, Thiart H, Heber E, Berking M. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial. Scand J Work Environ Health. 2014 Nov;40(6):582-96. doi: 10.5271/sjweh.3449. Epub 2014 Aug 13. — View Citation

Haug T, Nordgreen T, Öst LG, Havik OE. Self-help treatment of anxiety disorders: a meta-analysis and meta-regression of effects and potential moderators. Clin Psychol Rev. 2012 Jul;32(5):425-45. doi: 10.1016/j.cpr.2012.04.002. Epub 2012 Apr 21. — View Citation

Lin J, Ebert DD, Lehr D, Berking M, Baumeister H. [Internet based cognitive behavioral interventions: state of the art and implementation possibilities in rehabilitation]. Rehabilitation (Stuttg). 2013 Jun;52(3):155-63. doi: 10.1055/s-0033-1343491. Epub 2013 Jun 12. Review. German. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. — View Citation

Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28. — View Citation

Wolever RQ, Bobinet KJ, McCabe K, Mackenzie ER, Fekete E, Kusnick CA, Baime M. Effective and viable mind-body stress reduction in the workplace: a randomized controlled trial. J Occup Health Psychol. 2012 Apr;17(2):246-258. doi: 10.1037/a0027278. Epub 2012 Feb 20. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of psychic and somatoform complaints	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of depressiveness	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of phobic anxiety	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of somatoform complaints	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of mental well-being	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of interactional difficulties	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of self-efficacy	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of activity and participation	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of social support	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of social stress	according to the HEALTH-49 (Rabung et al., 2009)	up to 18 months
Secondary	change of employment prognosis	according to the subjective employment forecast (Mittag et al.,2006)	up to 18 months
Secondary	change of workability	according to the work ability index (Hasselhorn&Freude, 2007)	up to 18 months