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

NCT04989842 | Completed

• 1 other identifier: Curriculum Hannover Online
• Study Type: interventional
• Target: 6,023
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosomatic Disorder; Mental Disorder

Keywords

Rehabilitation; Psychosomatics; Aftercare; webbased aftercare therapy

Outcome Measures

Primary Outcomes (1)

• change of psychic and somatoform complaints

  according to the HEALTH-49 (Rabung et al., 2009)

  up to 18 months

Secondary Outcomes (11)

• change of depressiveness

  up to 18 months

• change of phobic anxiety

  up to 18 months

• change of somatoform complaints

  up to 18 months

• change of mental well-being

  up to 18 months

• change of interactional difficulties

  up to 18 months

Study Arms (4)

Intervention group 1

ACTIVE COMPARATOR

webbased aftercare

Behavioral: Curriculum Hannover

Control group

NO INTERVENTION

care as usual

Intervention group 2

ACTIVE COMPARATOR

webbased aftercare

Behavioral: Curriculum Hannover

face-to-face aftercare

ACTIVE COMPARATOR

face-to-face aftercare

Behavioral: Curriculum Hannover

Interventions

Curriculum Hannover BEHAVIORAL

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).

Intervention group 1; Intervention group 2; face-to-face aftercare

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Becker Hospital Group: lead

Study Sites (1)

Dr. Becker Hospital Group

Cologne, 50968, Germany

Location

Related Publications (13)

• 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.

  PMID: 25273302 BACKGROUND

• 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.

  PMID: 24844847 BACKGROUND

• 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.

  PMID: 22585048 BACKGROUND

• 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.

  PMID: 20579332 BACKGROUND

• 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.

  PMID: 20183688 BACKGROUND

• 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.

  PMID: 25121986 BACKGROUND

• 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.

  PMID: 23736751 BACKGROUND

• Haug T, Nordgreen T, Ost 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.

  PMID: 22681915 BACKGROUND

• 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. German.

  PMID: 23761204 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche 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. No abstract available.

  PMID: 20332511 BACKGROUND

• 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.

  PMID: 22352291 BACKGROUND

• 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.

  PMID: 22466510 BACKGROUND

• Lippke S, Gao L, Keller FM, Becker P, Dahmen A. Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials. J Med Internet Res. 2021 Nov 3;23(11):e31274. doi: 10.2196/31274.

  PMID: 34730541 DERIVED

MeSH Terms

Conditions

Psychophysiologic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alina Dahmen, MD

  Dr. Becker Hospital Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 4, 2021
• Study Start: March 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)